Trial Outcomes & Findings for Pecto-Intercostal Fascial Plane Block Study (NCT NCT04928339)
NCT ID: NCT04928339
Last Updated: 2024-11-19
Results Overview
Total opioid consumption during the initial 72 hours post-operatively will be measured in morphine milligram equivalents (MME) and compared between groups.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
up to 72 hours post-operatively
Results posted on
2024-11-19
Participant Flow
Participants were enrolled at UW Hospitals and Clinics from March 2022 until September 2023
Participant milestones
| Measure |
PIFB Intervention
bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)
Bupivacaine Injection: 10mL of 0.25% bupivacaine
Liposomal bupivacaine: 15mL of 133mg liposomal bupivacaine
|
Saline Control
bilateral PIFB with 25 mL saline only
Saline: 25mL saline control
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pecto-Intercostal Fascial Plane Block Study
Baseline characteristics by cohort
| Measure |
PIFB Intervention
n=50 Participants
bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)
Bupivacaine Injection: 10mL of 0.25% bupivacaine
Liposomal bupivacaine: 15mL of 133mg liposomal bupivacaine
|
Saline Control
n=50 Participants
bilateral PIFB with 25 mL saline only
Saline: 25mL saline control
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.50 years
n=5 Participants
|
64.00 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 72 hours post-operativelyTotal opioid consumption during the initial 72 hours post-operatively will be measured in morphine milligram equivalents (MME) and compared between groups.
Outcome measures
| Measure |
PIFB Intervention
n=50 Participants
bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)
Bupivacaine Injection: 10mL of 0.25% bupivacaine
Liposomal bupivacaine: 15mL of 133mg liposomal bupivacaine
|
Saline Control
n=50 Participants
bilateral PIFB with 25 mL saline only
Saline: 25mL saline control
|
|---|---|---|
|
Total Opioid Consumption 72 Hours Post-operatively
|
165.00 morphine milligram equivalents
Interval 102.97 to 283.8
|
205.05 morphine milligram equivalents
Interval 144.94 to 280.8
|
SECONDARY outcome
Timeframe: intraoperative period ranging from anesthesia start time to anesthesia end timeTotal intraoperative opioid consumption will be measured in morphine milligram equivalents (MME) and compared between groups.
Outcome measures
| Measure |
PIFB Intervention
n=50 Participants
bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)
Bupivacaine Injection: 10mL of 0.25% bupivacaine
Liposomal bupivacaine: 15mL of 133mg liposomal bupivacaine
|
Saline Control
n=50 Participants
bilateral PIFB with 25 mL saline only
Saline: 25mL saline control
|
|---|---|---|
|
Total Intraoperative Opioid Consumption
|
267.50 morphine milligram equivalents
Interval 180.75 to 305.4
|
229.80 morphine milligram equivalents
Interval 176.7 to 284.85
|
SECONDARY outcome
Timeframe: data collected immediately post-op, 24 hours, 48 hours, and 72 hours post-operativelyPain will be assessed, according to standard of care, every 4 hours using the 11-point Numerical Rating Scale (NRS), beginning at time 0 (arrival to ICU). Each patient's pain scores (higher scores indicate worse pain) within each postoperative day will be averaged, and the mean pain scores during each day and throughout the first 72 hours will be compared between the intervention and control groups. Median pain scores at 24, 48 and 72 hours post-op will be interrogated. Participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-10).
Outcome measures
| Measure |
PIFB Intervention
n=50 Participants
bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)
Bupivacaine Injection: 10mL of 0.25% bupivacaine
Liposomal bupivacaine: 15mL of 133mg liposomal bupivacaine
|
Saline Control
n=50 Participants
bilateral PIFB with 25 mL saline only
Saline: 25mL saline control
|
|---|---|---|
|
Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op
Median Pain at 72 hours post-operatively · low pain
|
46 Participants
|
47 Participants
|
|
Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op
Median Pain at 72 hours post-operatively · medium pain
|
2 Participants
|
1 Participants
|
|
Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op
Median Pain at 72 hours post-operatively · high pain
|
2 Participants
|
2 Participants
|
|
Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op
Median pain scores at 48 hours post-operatively post-op · low pain
|
3 Participants
|
4 Participants
|
|
Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op
Median pain scores at 48 hours post-operatively post-op · medium pain
|
19 Participants
|
22 Participants
|
|
Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op
Median pain scores at 48 hours post-operatively post-op · high pain
|
28 Participants
|
24 Participants
|
|
Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op
Median pain scores at 24 hours post-operatively · low pain
|
2 Participants
|
2 Participants
|
|
Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op
Median pain scores at 24 hours post-operatively · medium pain
|
17 Participants
|
16 Participants
|
|
Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op
Median pain scores at 24 hours post-operatively · high pain
|
31 Participants
|
32 Participants
|
|
Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op
Median Pain immediately post-operatively · low pain
|
2 Participants
|
0 Participants
|
|
Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op
Median Pain immediately post-operatively · medium pain
|
7 Participants
|
7 Participants
|
|
Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op
Median Pain immediately post-operatively · high pain
|
41 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: up to 72 hours post-opPain will be assessed, according to standard of care, every 4 hours using the 9-point Numerical Rating Scale (NRS) where higher score indicate worse pain, beginning at time 0 (arrival to ICU). The number of Participants reporting a Maximum pain score at 72 hours postoperatively will be reported. Participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-9).
Outcome measures
| Measure |
PIFB Intervention
n=50 Participants
bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)
Bupivacaine Injection: 10mL of 0.25% bupivacaine
Liposomal bupivacaine: 15mL of 133mg liposomal bupivacaine
|
Saline Control
n=50 Participants
bilateral PIFB with 25 mL saline only
Saline: 25mL saline control
|
|---|---|---|
|
Maximum Pain Scores up to 72 Hours Postoperatively
High Pain
|
29 Participants
|
25 Participants
|
|
Maximum Pain Scores up to 72 Hours Postoperatively
Medium Pain
|
19 Participants
|
22 Participants
|
|
Maximum Pain Scores up to 72 Hours Postoperatively
Low Pain
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: up to 90 days post-opPain will be assessed, according to standard of care, every 4 hours using the 11-point Numerical Rating Scale (NRS) where higher score indicate worse pain. Pain at 90 days postoperative will be surveyed by phone. Pain will be assessed participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-10).
Outcome measures
| Measure |
PIFB Intervention
n=50 Participants
bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)
Bupivacaine Injection: 10mL of 0.25% bupivacaine
Liposomal bupivacaine: 15mL of 133mg liposomal bupivacaine
|
Saline Control
n=50 Participants
bilateral PIFB with 25 mL saline only
Saline: 25mL saline control
|
|---|---|---|
|
Pain Score at 90 Days Postoperatively
Within 24 hours, worst pain
|
3 pain score units on a scale
Interval 1.0 to 5.0
|
2 pain score units on a scale
Interval 1.0 to 3.0
|
|
Pain Score at 90 Days Postoperatively
Within 24 hours, least pain
|
0 pain score units on a scale
Interval 0.0 to 2.0
|
0 pain score units on a scale
Interval 0.0 to 1.0
|
|
Pain Score at 90 Days Postoperatively
Within 24 hours, average pain
|
2 pain score units on a scale
Interval 0.0 to 4.0
|
1 pain score units on a scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: up to 72 hours post-opDaily opioid consumption during the initial 72 hours postoperatively will be measured in milligrams of morphine equivalents and compared between groups.
Outcome measures
| Measure |
PIFB Intervention
n=50 Participants
bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)
Bupivacaine Injection: 10mL of 0.25% bupivacaine
Liposomal bupivacaine: 15mL of 133mg liposomal bupivacaine
|
Saline Control
n=50 Participants
bilateral PIFB with 25 mL saline only
Saline: 25mL saline control
|
|---|---|---|
|
Daily Opioid Consumption up to 72 Hours Postoperatively
Opioid Consumption from 0 to 24 hours post-operatively
|
90 milligrams of morphine equivalents
Interval 52.8 to 135.6
|
103.80 milligrams of morphine equivalents
Interval 73.43 to 137.02
|
|
Daily Opioid Consumption up to 72 Hours Postoperatively
Opioid Consumption between 24-48 hours post-operatively
|
58.35 milligrams of morphine equivalents
Interval 37.5 to 79.95
|
75.00 milligrams of morphine equivalents
Interval 29.55 to 105.0
|
|
Daily Opioid Consumption up to 72 Hours Postoperatively
Opioid Consumption between 48-72 hours post-operatively
|
26.25 milligrams of morphine equivalents
Interval 7.88 to 45.0
|
30.00 milligrams of morphine equivalents
Interval 0.0 to 60.0
|
SECONDARY outcome
Timeframe: up to 72 hours post-opDuration of mechanical ventilation will be measured by hours of mechanical ventilation after admission to the ICU.
Outcome measures
| Measure |
PIFB Intervention
n=50 Participants
bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)
Bupivacaine Injection: 10mL of 0.25% bupivacaine
Liposomal bupivacaine: 15mL of 133mg liposomal bupivacaine
|
Saline Control
n=50 Participants
bilateral PIFB with 25 mL saline only
Saline: 25mL saline control
|
|---|---|---|
|
Hours of Mechanical Ventilation After ICU Admission
|
4.03 hours
Interval 3.03 to 6.32
|
4.46 hours
Interval 2.98 to 8.11
|
SECONDARY outcome
Timeframe: up to 72 hours post-opReturn of bowel function will be measured in the number of postoperative days until the first bowel movement.
Outcome measures
| Measure |
PIFB Intervention
n=50 Participants
bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)
Bupivacaine Injection: 10mL of 0.25% bupivacaine
Liposomal bupivacaine: 15mL of 133mg liposomal bupivacaine
|
Saline Control
n=50 Participants
bilateral PIFB with 25 mL saline only
Saline: 25mL saline control
|
|---|---|---|
|
Number of Postoperative Days Until the First Bowel Movement
|
2.81 days
Interval 2.19 to 3.0
|
2.60 days
Interval 2.06 to 2.99
|
SECONDARY outcome
Timeframe: up to 72 hours post-opPostoperative delirium episodes will be measured according to standard of care by utilizing the CAM-ICU assessment every 8-12 hours. The CAM-ICU determines either 'yes' or 'no' the participant is experiencing delirium. The number of of delirium episodes within 72 hours post-op will be determined.
Outcome measures
| Measure |
PIFB Intervention
n=50 Participants
bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)
Bupivacaine Injection: 10mL of 0.25% bupivacaine
Liposomal bupivacaine: 15mL of 133mg liposomal bupivacaine
|
Saline Control
n=50 Participants
bilateral PIFB with 25 mL saline only
Saline: 25mL saline control
|
|---|---|---|
|
Number of Participants Reporting Postoperative Delirium Episodes Per the Confusion Assessment Method for the ICU (CAM-ICU)
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: up to 72 hours post-opDuration of ICU stay will be measured by the number of hours that the patient is in the ICU until an order is placed for transfer to a lower level of care.
Outcome measures
| Measure |
PIFB Intervention
n=50 Participants
bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)
Bupivacaine Injection: 10mL of 0.25% bupivacaine
Liposomal bupivacaine: 15mL of 133mg liposomal bupivacaine
|
Saline Control
n=50 Participants
bilateral PIFB with 25 mL saline only
Saline: 25mL saline control
|
|---|---|---|
|
Number of Hours That the Patient is in the ICU
|
20.94 hours
Interval 17.38 to 23.07
|
20.00 hours
Interval 17.28 to 24.32
|
SECONDARY outcome
Timeframe: Up to 7 daysDuration of hospital stay will be measured by the number of post-operative days until the patient is discharged.
Outcome measures
| Measure |
PIFB Intervention
n=50 Participants
bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)
Bupivacaine Injection: 10mL of 0.25% bupivacaine
Liposomal bupivacaine: 15mL of 133mg liposomal bupivacaine
|
Saline Control
n=50 Participants
bilateral PIFB with 25 mL saline only
Saline: 25mL saline control
|
|---|---|---|
|
Number of Post-operative Days Until the Patient is Discharged
|
4.60 days
Interval 3.84 to 5.68
|
4.51 days
Interval 3.89 to 5.77
|
SECONDARY outcome
Timeframe: up to 90 days post-opPatient use of opioids at 90 days will be obtained by phone call.
Outcome measures
| Measure |
PIFB Intervention
n=50 Participants
bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)
Bupivacaine Injection: 10mL of 0.25% bupivacaine
Liposomal bupivacaine: 15mL of 133mg liposomal bupivacaine
|
Saline Control
n=50 Participants
bilateral PIFB with 25 mL saline only
Saline: 25mL saline control
|
|---|---|---|
|
Count of Participants Using Opioids at 90 Days Postoperatively
|
2 count of participants
|
1 count of participants
|
Adverse Events
PIFB Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place