Trial Outcomes & Findings for Local Anesthetic as Single Shot Versus Catheter in Patients Undergoing Video Assisted Thoracoscopic Surgery (NCT NCT04559347)
NCT ID: NCT04559347
Last Updated: 2025-06-12
Results Overview
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
TERMINATED
PHASE2
45 participants
0-4 hours post operative
2025-06-12
Participant Flow
Participant milestones
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
22
|
|
Overall Study
COMPLETED
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Thoracotomy conversion
|
1
|
1
|
|
Overall Study
Provider unavailable
|
2
|
1
|
|
Overall Study
Other
|
2
|
1
|
Baseline Characteristics
Due to per protocol analysis for the noninferiority study, the number analyzed differs from the number randomized. For the Exparel group: 23 subjects were randomized but only 17 subjects complied with protocol to include in final analysis.For the continuous catheter bupivacaine group: 22 subjects were randomized but only 19 complied with the protocol to include in final analysis. For the safety analysis of adverse events, all 45 subjectswere included in the analysis.
Baseline characteristics by cohort
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=19 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.53 years
STANDARD_DEVIATION 9.45 • n=17 Participants • Due to per protocol analysis for the noninferiority study, the number analyzed differs from the number randomized. For the Exparel group: 23 subjects were randomized but only 17 subjects complied with protocol to include in final analysis.For the continuous catheter bupivacaine group: 22 subjects were randomized but only 19 complied with the protocol to include in final analysis. For the safety analysis of adverse events, all 45 subjectswere included in the analysis.
|
65.21 years
STANDARD_DEVIATION 12.91 • n=19 Participants • Due to per protocol analysis for the noninferiority study, the number analyzed differs from the number randomized. For the Exparel group: 23 subjects were randomized but only 17 subjects complied with protocol to include in final analysis.For the continuous catheter bupivacaine group: 22 subjects were randomized but only 19 complied with the protocol to include in final analysis. For the safety analysis of adverse events, all 45 subjectswere included in the analysis.
|
65.36 years
STANDARD_DEVIATION 11.25 • n=36 Participants • Due to per protocol analysis for the noninferiority study, the number analyzed differs from the number randomized. For the Exparel group: 23 subjects were randomized but only 17 subjects complied with protocol to include in final analysis.For the continuous catheter bupivacaine group: 22 subjects were randomized but only 19 complied with the protocol to include in final analysis. For the safety analysis of adverse events, all 45 subjectswere included in the analysis.
|
|
Sex: Female, Male
Female
|
10 Participants
n=17 Participants
|
8 Participants
n=19 Participants
|
18 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=17 Participants
|
11 Participants
n=19 Participants
|
18 Participants
n=36 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
17 participants
n=17 Participants
|
19 participants
n=19 Participants
|
36 participants
n=36 Participants
|
|
Tobacco History
Quit more than 12 months ago
|
7 Participants
n=17 Participants
|
12 Participants
n=19 Participants
|
19 Participants
n=36 Participants
|
|
Tobacco History
Never
|
7 Participants
n=17 Participants
|
5 Participants
n=19 Participants
|
12 Participants
n=36 Participants
|
|
Tobacco History
Current
|
3 Participants
n=17 Participants
|
2 Participants
n=19 Participants
|
5 Participants
n=36 Participants
|
|
Chronic liver disease (CLD) history
|
0 Participants
n=17 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=36 Participants
|
|
Chronic obstructive pulmonary disease (COPD) History
|
0 Participants
n=17 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=36 Participants
|
|
Diabetes History
|
2 Participants
n=17 Participants
|
1 Participants
n=19 Participants
|
3 Participants
n=36 Participants
|
|
American Society of Anesthesiologists (ASA) Physical Status
2
|
3 Participants
n=17 Participants
|
3 Participants
n=19 Participants
|
6 Participants
n=36 Participants
|
|
American Society of Anesthesiologists (ASA) Physical Status
3
|
13 Participants
n=17 Participants
|
16 Participants
n=19 Participants
|
29 Participants
n=36 Participants
|
|
American Society of Anesthesiologists (ASA) Physical Status
4
|
1 Participants
n=17 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=36 Participants
|
|
Primary Procedure
Video-assisted thoracoscopic surgery (VATS) with Lobectomy
|
12 Participants
n=17 Participants
|
10 Participants
n=19 Participants
|
22 Participants
n=36 Participants
|
|
Primary Procedure
Video-assisted thoracoscopic surgery (VATS) with Wedge Biopsy
|
3 Participants
n=17 Participants
|
7 Participants
n=19 Participants
|
10 Participants
n=36 Participants
|
|
Primary Procedure
Video-assisted thoracoscopic surgery (VATS)
|
2 Participants
n=17 Participants
|
2 Participants
n=19 Participants
|
4 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 0-4 hours post operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=17 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Numeric Rated Pain Scale at Rest 0-4 Hours Post-operative
|
4.824 score on a scale
Standard Deviation 2.531
|
5.176 score on a scale
Standard Deviation 2.744
|
PRIMARY outcome
Timeframe: 4-8 hours post operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=15 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=15 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Numeric Rated Pain Scale at Rest 4-8 Hours Post-operative
|
3.867 score on a scale
Standard Deviation 2.774
|
3.133 score on a scale
Standard Deviation 2.386
|
PRIMARY outcome
Timeframe: 8-12 hours post operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=13 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=15 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Numeric Rated Pain Scale at Rest 8-12 Hours Post-operative
|
2.923 score on a scale
Standard Deviation 2.253
|
3.4 score on a scale
Standard Deviation 2.384
|
PRIMARY outcome
Timeframe: 12-24 hours post operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=14 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=16 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Numeric Rated Pain Scale at Rest 12-24 Hours Post-operative
|
3.714 score on a scale
Standard Deviation 2.367
|
5.312 score on a scale
Standard Deviation 3.114
|
PRIMARY outcome
Timeframe: 2 days post operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=16 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=16 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Numeric Rated Pain Scale at Rest 24-48 Hours Post-operative
|
4.188 score on a scale
Standard Deviation 2.482
|
4.125 score on a scale
Standard Deviation 2.187
|
PRIMARY outcome
Timeframe: 3 days post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=9 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=6 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Numeric Rated Pain Scale 48-72 Hours Post-operative
|
3.333 score on a scale
Standard Deviation 2.179
|
4.833 score on a scale
Standard Deviation 2.639
|
PRIMARY outcome
Timeframe: 0-4 hours post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=17 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Numeric Rated Pain Scale With Cough 0-4 Hours Post-operative
|
6.765 score on a scale
Standard Deviation 2.306
|
7 score on a scale
Standard Deviation 2.784
|
PRIMARY outcome
Timeframe: 4-8 hours post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=15 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=14 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Numeric Rated Pain Scale With Cough 4-8 Hours Post-operative
|
7 score on a scale
Standard Deviation 2.171
|
5.357 score on a scale
Standard Deviation 2.872
|
PRIMARY outcome
Timeframe: 8-12 hours post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=13 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=15 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Numeric Rated Pain Scale With Cough 8-12 Hours Post-operative
|
6.615 score on a scale
Standard Deviation 2.534
|
5.867 score on a scale
Standard Deviation 2.85
|
PRIMARY outcome
Timeframe: 12-24 hours post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=15 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=16 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Numeric Rated Pain Scale With Cough 12-24 Hours Post-operative
|
7.467 score on a scale
Standard Deviation 2.2
|
7.062 score on a scale
Standard Deviation 2.435
|
PRIMARY outcome
Timeframe: 24-48 hours post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=16 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=16 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Numeric Rated Pain Scale With Cough 24-48 Hours Post-operative
|
6.875 score on a scale
Standard Deviation 2.391
|
7.5 score on a scale
Standard Deviation 2.309
|
PRIMARY outcome
Timeframe: 48-72 hours post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=9 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=6 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Numeric Rated Pain Scale With Cough 48-72 Hours Post-operative
|
6.889 score on a scale
Standard Deviation 2.667
|
6.833 score on a scale
Standard Deviation 2.563
|
SECONDARY outcome
Timeframe: 0-4 hours post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=18 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Opioid Consumption in Morphine Equivalent Dose 0-4 Hours Post-operative
|
23.47 milligram morphine equivalents (MME)
Standard Deviation 20.74
|
37.89 milligram morphine equivalents (MME)
Standard Deviation 22.73
|
SECONDARY outcome
Timeframe: 4-8 hours post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=18 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Opioid Consumption in Morphine Equivalent Dose 4-8 Hours Post-operative
|
29.00 milligram morphine equivalents (MME)
Standard Deviation 26.91
|
39.94 milligram morphine equivalents (MME)
Standard Deviation 23.83
|
SECONDARY outcome
Timeframe: 8-16 hours post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=18 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Opioid Consumption in Morphine Equivalent Dose 8-16 Hours Post-operative
|
38.44 milligram morphine equivalents (MME)
Standard Deviation 34.04
|
52.53 milligram morphine equivalents (MME)
Standard Deviation 29.37
|
SECONDARY outcome
Timeframe: 16-24 hours post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Post-operative opioid consumption in morphine equivalent dose (MED to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=18 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Opioid Consumption in Morphine Equivalent Dose 16-24 Hours Post-operative
|
48.06 milligram morphine equivalents (MME)
Standard Deviation 44.36
|
64.64 milligram morphine equivalents (MME)
Standard Deviation 36.77
|
SECONDARY outcome
Timeframe: 24-48 hours post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=18 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Opioid Consumption in Morphine Equivalent Dose 24-48 Hours Post-operative
|
67.71 milligram morphine equivalents (MME)
Standard Deviation 65.83
|
92.64 milligram morphine equivalents (MME)
Standard Deviation 57.43
|
SECONDARY outcome
Timeframe: 48-72 hours post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=18 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Opioid Consumption in Morphine Equivalent Dose 48-72 Hours Post-operative
|
76.38 milligram morphine equivalents (MME)
Standard Deviation 80.33
|
105.61 milligram morphine equivalents (MME)
Standard Deviation 69.30
|
SECONDARY outcome
Timeframe: From start of surgery to end of surgery, an average of 2-3 hoursTotal opioids administered in morphine equivalent dose (MED) in the operating room during the surgery. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=19 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Total Intraoperative Opioid Consumption in Morphine Equivalent Dose
|
63.1 milligram morphine equivalents (MME)
Standard Deviation 31.7
|
64.1 milligram morphine equivalents (MME)
Standard Deviation 35.4
|
SECONDARY outcome
Timeframe: 0-4 hours post-operativeAcetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=19 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Acetaminophen Consumption in Milligrams 0-4 Hours Post-operative
|
679 milligrams
Standard Deviation 363
|
453 milligrams
Standard Deviation 459
|
SECONDARY outcome
Timeframe: 4-8 hours post-operativeAcetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=19 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Acetaminophen Consumption in Milligrams 4-8 Hours Post-operative
|
250 milligrams
Standard Deviation 358
|
329 milligrams
Standard Deviation 412
|
SECONDARY outcome
Timeframe: 8-16 hours post-operativeAcetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=19 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Acetaminophen Consumption in Milligrams 8-16 Hours Post-operative
|
988 milligrams
Standard Deviation 398
|
842 milligrams
Standard Deviation 462
|
SECONDARY outcome
Timeframe: 16-24 hours post-operativeAcetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=19 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Acetaminophen Consumption in Milligrams 16-24 Hours Post-operative
|
835 milligrams
Standard Deviation 513
|
900 milligrams
Standard Deviation 596
|
SECONDARY outcome
Timeframe: 24-48 hours post-operativeAcetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=19 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Acetaminophen Consumption in Milligrams 24-48 Hours Post-operative
|
2159 milligrams
Standard Deviation 1393
|
2676 milligrams
Standard Deviation 1699
|
SECONDARY outcome
Timeframe: 48-72 hours post-operativeAcetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=19 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Acetaminophen Consumption in Milligrams 48-72 Hours Post-operative
|
1385 milligrams
Standard Deviation 1391
|
1453 milligrams
Standard Deviation 1843
|
SECONDARY outcome
Timeframe: 0-4 hours post-operativeGabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=19 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Gabapentin Consumption in Milligrams 0-4 Hours Post-operative
|
58.82 milligrams
Standard Deviation 100.37
|
68.42 milligrams
Standard Deviation 149.27
|
SECONDARY outcome
Timeframe: 4-8 hours post-operativeGabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=19 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Gabapentin Consumption in Milligrams 4-8 Hours Post-operative
|
52.94 milligrams
Standard Deviation 117.89
|
36.84 milligrams
Standard Deviation 76.09
|
SECONDARY outcome
Timeframe: 8-16 hours post-operativeGabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=19 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Gabapentin Consumption in Milligrams 8-16 Hours Post-operative
|
82.35 milligrams
Standard Deviation 113.11
|
115.79 milligrams
Standard Deviation 167.54
|
SECONDARY outcome
Timeframe: 16-24 hours post-operativeGabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=19 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Gabapentin Consumption in Milligrams 16-24 Hours Post-operative
|
100.00 milligrams
Standard Deviation 122.47
|
189.47 milligrams
Standard Deviation 196.91
|
SECONDARY outcome
Timeframe: 24-48 hours post-operativeGabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=19 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Gabapentin Consumption in Milligrams 24-48 Hours Post-operative
|
223.53 milligrams
Standard Deviation 343.75
|
452.63 milligrams
Standard Deviation 505.93
|
SECONDARY outcome
Timeframe: 48-72 hours post-operativeGabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=19 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Gabapentin Consumption in Milligrams 48-72 Hours Post-operative
|
152.94 milligrams
Standard Deviation 260.09
|
300.00 milligrams
Standard Deviation 458.26
|
SECONDARY outcome
Timeframe: 0-4 hours post-operativeThe ketorolac use in milligrams will be compared in each group at different time points.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=19 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Ketorolac Consumption in Milligrams 0-4 Hours Post-operative
|
1.765 milligrams
Standard Deviation 7.276
|
2.895 milligrams
Standard Deviation 7.695
|
SECONDARY outcome
Timeframe: 4-8 hours post-operativeThe ketorolac use in milligrams will be compared in each group at different time points.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=19 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Ketorolac Consumption in Milligrams 4-8 Hours Post-operative
|
3.529 milligrams
Standard Deviation 8.434
|
0.789 milligrams
Standard Deviation 3.441
|
SECONDARY outcome
Timeframe: 8-16 hours post-operativeThe ketorolac use in milligrams will be compared in each group at different time points.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=19 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Ketorolac Consumption in Milligrams 8-16 Hours Post-operative
|
6.176 milligrams
Standard Deviation 10.684
|
5.789 milligrams
Standard Deviation 10.576
|
SECONDARY outcome
Timeframe: 16-24 hours post-operativeThe ketorolac use in milligrams will be compared in each group at different time points.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=19 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Ketorolac Consumption in Milligrams 16-24 Hours Post-operative
|
0 milligrams
Standard Deviation 0
|
8.421 milligrams
Standard Deviation 11.432
|
SECONDARY outcome
Timeframe: 24-48 hours post-operative.The ketorolac use in milligrams will be compared in each group at different time points.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=19 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Ketorolac Consumption in Milligrams 24-48 Hours Post-operative
|
17.647 milligrams
Standard Deviation 35.669
|
21.842 milligrams
Standard Deviation 26.416
|
SECONDARY outcome
Timeframe: 48-72 hours post-operativeKetorolac is a pain medication that is not an opioid. The ketorolac use in milligrams will be compared in each group at different time points.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=19 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Ketorolac Consumption in Milligrams 48-72 Hours Post-operative
|
11.471 milligrams
Standard Deviation 24.607
|
5.526 milligrams
Standard Deviation 14.327
|
SECONDARY outcome
Timeframe: 12-24 hours post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
A survey on patient reported outcomes which consists of 15 questions related to five domains of patient reported health status (pain, physical comfort, physical independence, psychological support and emotional state). The score is reported on a scale from 0 to 150 with higher scores meaning a better outcome.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=12 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=9 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Postoperative Quality of Recovery Score (QOR-15) 12-24 Hours Post-operative
|
8.24 score on a scale
Standard Deviation 0.96
|
7.29 score on a scale
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: 24-48 hours post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
A survey on patient reported outcomes which consists of 15 questions related to five domains of patient reported health status (pain, physical comfort, physical independence, psychological support and emotional state). The score is reported on a scale from 0 to 150 with higher scores meaning a better outcome.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=13 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=8 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Postoperative Quality of Recovery Score (QOR-15) 24 to 48 Hours Post-operative
|
8.26 score on a scale
Standard Deviation 0.77
|
8.40 score on a scale
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: 48-72 hours post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
A survey on patient reported outcomes which consists of 15 questions related to five domains of patient reported health status (pain, physical comfort, physical independence, psychological support and emotional state). The score is reported on a scale from 0 to 150 with higher scores meaning a better outcome.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=6 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=4 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Postoperative Quality of Recovery Score (QOR-15) 48 to 72 Hours Post-operative
|
8.56 score on a scale
Standard Deviation 0.90
|
8.52 score on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: 0-4 hours post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 0 to 4 hours post-operative). A negative number reflects reduced volume of air.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=16 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=18 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 0-4 Hours Post-operative
|
-956.25 volume of air in cubic centimeters
Standard Deviation 528.796
|
-652.778 volume of air in cubic centimeters
Standard Deviation 596.429
|
SECONDARY outcome
Timeframe: 4-8 hours post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 4 to 8 hours post-operative). A negative number reflects reduced volume of air.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=13 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=14 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 4-8 Hours Post-operative
|
-815.385 volume of air in cubic centimeters
Standard Deviation 632.582
|
-775 volume of air in cubic centimeters
Standard Deviation 765.544
|
SECONDARY outcome
Timeframe: 8-12 hours post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 8 to 12 hours post-operative). A negative number reflects reduced volume of air.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=9 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=11 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 8-12 Hours Post-operative
|
-1005.556 volume of air in cubic centimeters
Standard Deviation 682.113
|
-959.091 volume of air in cubic centimeters
Standard Deviation 654.912
|
SECONDARY outcome
Timeframe: 12-24 hours post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 12 to 24 hours post-operative). A negative number reflects reduced volume of air.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=15 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=15 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 12-24 Hours Post-operative
|
-718.333 volume of air in cubic centimeters
Standard Deviation 575.114
|
-853.333 volume of air in cubic centimeters
Standard Deviation 747.01
|
SECONDARY outcome
Timeframe: 24-48 hours post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 24 to 48 hours post-operative). A negative number reflects reduced volume of air.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=14 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=17 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 24-48 Hours Post-operative
|
-975 volume of air in cubic centimeters
Standard Deviation 640.538
|
-700 volume of air in cubic centimeters
Standard Deviation 537.936
|
SECONDARY outcome
Timeframe: 48-72 hours post-operativePopulation: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 48 to 72 hours post-operative). A negative number reflects reduced volume of air.
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=8 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=7 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 48-72 Hours Post-operative
|
-906.25 volume of air in cubic centimeters
Standard Deviation 651.612
|
-642.857 volume of air in cubic centimeters
Standard Deviation 403.556
|
SECONDARY outcome
Timeframe: From date of admission until date of discharge, an average of 72 hoursNumber of hours from admission to discharge
Outcome measures
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=17 Participants
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=19 Participants
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Length of Hospital Stay
|
72.00 Hours
Interval 53.0 to 79.0
|
58.00 Hours
Interval 55.0 to 77.5
|
Adverse Events
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
Continuous Catheter Infusion Ropivacaine
Serious adverse events
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=23 participants at risk
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=22 participants at risk
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Subcutaneous emphysema
|
4.3%
1/23 • Number of events 1 • From start of surgery to up to 72 hours post-operative
Adverse events are reported for all randomized participants
|
0.00%
0/22 • From start of surgery to up to 72 hours post-operative
Adverse events are reported for all randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.3%
1/23 • Number of events 1 • From start of surgery to up to 72 hours post-operative
Adverse events are reported for all randomized participants
|
4.5%
1/22 • Number of events 1 • From start of surgery to up to 72 hours post-operative
Adverse events are reported for all randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.3%
1/23 • Number of events 1 • From start of surgery to up to 72 hours post-operative
Adverse events are reported for all randomized participants
|
4.5%
1/22 • Number of events 1 • From start of surgery to up to 72 hours post-operative
Adverse events are reported for all randomized participants
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/23 • From start of surgery to up to 72 hours post-operative
Adverse events are reported for all randomized participants
|
4.5%
1/22 • Number of events 1 • From start of surgery to up to 72 hours post-operative
Adverse events are reported for all randomized participants
|
|
Surgical and medical procedures
Intraoperative hemorrhage
|
4.3%
1/23 • Number of events 1 • From start of surgery to up to 72 hours post-operative
Adverse events are reported for all randomized participants
|
0.00%
0/22 • From start of surgery to up to 72 hours post-operative
Adverse events are reported for all randomized participants
|
Other adverse events
| Measure |
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
n=23 participants at risk
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block
|
Continuous Catheter Infusion Ropivacaine
n=22 participants at risk
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
4.3%
1/23 • Number of events 1 • From start of surgery to up to 72 hours post-operative
Adverse events are reported for all randomized participants
|
0.00%
0/22 • From start of surgery to up to 72 hours post-operative
Adverse events are reported for all randomized participants
|
|
Surgical and medical procedures
Pain of skin
|
4.3%
1/23 • From start of surgery to up to 72 hours post-operative
Adverse events are reported for all randomized participants
|
4.5%
1/22 • Number of events 1 • From start of surgery to up to 72 hours post-operative
Adverse events are reported for all randomized participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
1/23 • Number of events 1 • From start of surgery to up to 72 hours post-operative
Adverse events are reported for all randomized participants
|
0.00%
0/22 • From start of surgery to up to 72 hours post-operative
Adverse events are reported for all randomized participants
|
|
Surgical and medical procedures
Postoperative thoracic procedure complication
|
0.00%
0/23 • From start of surgery to up to 72 hours post-operative
Adverse events are reported for all randomized participants
|
4.5%
1/22 • Number of events 1 • From start of surgery to up to 72 hours post-operative
Adverse events are reported for all randomized participants
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place