Trial Outcomes & Findings for Erector Spinae Block for Spine Surgery (NCT NCT05417113)
NCT ID: NCT05417113
Last Updated: 2024-05-29
Results Overview
The amount of postoperative intravenous opioid consumption (Total morphine mg equivalents MME) during the first 72 hours
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
13 participants
Primary outcome timeframe
12 hours, 24 hours, 48 hours, 72 hours
Results posted on
2024-05-29
Participant Flow
Participant milestones
| Measure |
Bupivacaine Only
Bupivacaine: bupivacaine 0.25% in ESP blocks
|
Liposomal Bupivacaine and Bupivacaine
Liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Bupivacaine Only
Bupivacaine: bupivacaine 0.25% in ESP blocks
|
Liposomal Bupivacaine and Bupivacaine
Liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
Erector Spinae Block for Spine Surgery
Baseline characteristics by cohort
| Measure |
Bupivacaine Only
n=5 Participants
Bupivacaine: bupivacaine 0.25% in ESP blocks
|
Liposomal Bupivacaine and Bupivacaine
n=4 Participants
Liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 13.35 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 6.70 • n=7 Participants
|
63.44 years
STANDARD_DEVIATION 10.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Weight
|
80.58 kg
STANDARD_DEVIATION 17.23 • n=5 Participants
|
78.88 kg
STANDARD_DEVIATION 22.49 • n=7 Participants
|
79.82 kg
STANDARD_DEVIATION 18.41 • n=5 Participants
|
|
ASA Physical Status
|
2.2 units on a scale
STANDARD_DEVIATION 0.45 • n=5 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 0.58 • n=7 Participants
|
2.33 units on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 hours, 24 hours, 48 hours, 72 hoursThe amount of postoperative intravenous opioid consumption (Total morphine mg equivalents MME) during the first 72 hours
Outcome measures
| Measure |
Bupivacaine Only
n=5 Participants
Bupivacaine: bupivacaine 0.25% in ESP blocks
|
Liposomal Bupivacaine and Bupivacaine
n=4 Participants
Liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks
|
|---|---|---|
|
Postoperative Opioid Consumption During First 72 Hours
12 hours
|
11.69 MME
Standard Deviation 8.26
|
22.63 MME
Standard Deviation 4.02
|
|
Postoperative Opioid Consumption During First 72 Hours
24 hours
|
19.56 MME
Standard Deviation 13.14
|
39.79 MME
Standard Deviation 19.36
|
|
Postoperative Opioid Consumption During First 72 Hours
48 hours
|
30.66 MME
Standard Deviation 32.46
|
73.88 MME
Standard Deviation 15.05
|
|
Postoperative Opioid Consumption During First 72 Hours
72 hours
|
38.99 MME
Standard Deviation 39.03
|
93.42 MME
Standard Deviation 31.35
|
SECONDARY outcome
Timeframe: up to 12 weeksChange in the severity of pain at rest using an 11-point Likert scale. Scale from 0-10, with higher score indicating more pain.
Outcome measures
| Measure |
Bupivacaine Only
n=5 Participants
Bupivacaine: bupivacaine 0.25% in ESP blocks
|
Liposomal Bupivacaine and Bupivacaine
n=4 Participants
Liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks
|
|---|---|---|
|
Change in Pain Score
1 hour post-operatively
|
4.0 score on a scale
Standard Deviation 2.74
|
4.5 score on a scale
Standard Deviation 3.11
|
|
Change in Pain Score
6 hours post-operatively
|
2.0 score on a scale
Standard Deviation 1.41
|
4.5 score on a scale
Standard Deviation 3.87
|
|
Change in Pain Score
12 hours post-operatively
|
2.6 score on a scale
Standard Deviation 4.34
|
3.75 score on a scale
Standard Deviation 3.30
|
|
Change in Pain Score
24 hours post-operatively
|
2.8 score on a scale
Standard Deviation 2.77
|
5.5 score on a scale
Standard Deviation 2.89
|
|
Change in Pain Score
48 hours post-operatively
|
5.6 score on a scale
Standard Deviation 3.78
|
5.0 score on a scale
Standard Deviation 3.56
|
|
Change in Pain Score
72 hours post-operatively
|
5.0 score on a scale
Standard Deviation 3.61
|
5.0 score on a scale
Standard Deviation 3.56
|
|
Change in Pain Score
2 weeks hours post-operatively
|
4.6 score on a scale
Standard Deviation 2.30
|
4.25 score on a scale
Standard Deviation 2.06
|
|
Change in Pain Score
6 weeks hours post-operatively
|
2.4 score on a scale
Standard Deviation 3.36
|
3.75 score on a scale
Standard Deviation 4.19
|
|
Change in Pain Score
12 weeks hours post-operatively
|
2.2 score on a scale
Standard Deviation 3.19
|
3.0 score on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: 72 hoursChange in general quality of recovery using a 15 point questionnaire via QoR-15 with regard to how the patient is feeling scored on a scale from 0-10, with 0 being none of the time and 10 being all of the time. Full scale range from 0-150, with a higher score indicating a better health outcome.
Outcome measures
| Measure |
Bupivacaine Only
n=5 Participants
Bupivacaine: bupivacaine 0.25% in ESP blocks
|
Liposomal Bupivacaine and Bupivacaine
n=4 Participants
Liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks
|
|---|---|---|
|
Quality of Recovery (QOR 15)
|
123.2 score on a scale
Standard Deviation 7.39
|
108.0 score on a scale
Standard Deviation 35.15
|
SECONDARY outcome
Timeframe: in PACU (4 hours)Number of participants with postoperative nausea/vomiting (PONV) in PACU
Outcome measures
| Measure |
Bupivacaine Only
n=5 Participants
Bupivacaine: bupivacaine 0.25% in ESP blocks
|
Liposomal Bupivacaine and Bupivacaine
n=4 Participants
Liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks
|
|---|---|---|
|
Number of Participants With Postoperative Nausea/Vomiting (PONV)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: average 26-27 hoursTime to ambulation in hours
Outcome measures
| Measure |
Bupivacaine Only
n=5 Participants
Bupivacaine: bupivacaine 0.25% in ESP blocks
|
Liposomal Bupivacaine and Bupivacaine
n=4 Participants
Liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks
|
|---|---|---|
|
Time to Ambulation
|
26.03 hours
Standard Deviation 12.58
|
27.13 hours
Standard Deviation 14.94
|
SECONDARY outcome
Timeframe: average 72 hoursHospital length of stay (LOS)
Outcome measures
| Measure |
Bupivacaine Only
n=5 Participants
Bupivacaine: bupivacaine 0.25% in ESP blocks
|
Liposomal Bupivacaine and Bupivacaine
n=4 Participants
Liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks
|
|---|---|---|
|
Hospital Length of Stay
|
3 days
Standard Deviation 2.35
|
3.5 days
Standard Deviation 0.58
|
Adverse Events
Bupivacaine Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Liposomal Bupivacaine and Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Christina Jeng
Icahn School of Medicine at Mount Sinai
Phone: 212-241-4743
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60