Trial Outcomes & Findings for Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction (NCT NCT04777591)
NCT ID: NCT04777591
Last Updated: 2024-08-23
Results Overview
Visual analog pain scale. Scores range from 0 to 10, 0 being no pain and 10 being worse pain that one experienced in their lifetime.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
117 participants
Primary outcome timeframe
During initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first
Results posted on
2024-08-23
Participant Flow
Participant milestones
| Measure |
Control - Plain Bupivacaine
Receives plain bupivacaine TAP block as part of multi-modal pain control intraoperatively
Bupivacain: Group will receive plain bupivacaine TAP block intraoperatively during free flap breast reconstruction as part of the multimodal pain control.
|
Experimental - Liposomal Bupivacaine
Receives plain bupivacaine + liposomal bupivacaine TAP block as part of multi-modal pain control intraoperatively
Liposomal bupivacaine TAP block: Group will receive Liposomal bupivacaine TAP block (mixed with plain bupivacaine) intraoperatively during free flap breast reconstruction as part of the multimodal pain control.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
58
|
|
Overall Study
COMPLETED
|
59
|
58
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control - Plain Bupivacaine
n=59 Participants
Receives plain bupivacaine TAP block as part of multi-modal pain control intraoperatively
Bupivacain: Group will receive plain bupivacaine TAP block intraoperatively during free flap breast reconstruction as part of the multimodal pain control.
|
Experimental - Liposomal Bupivacaine
n=58 Participants
Receives plain bupivacaine + liposomal bupivacaine TAP block as part of multi-modal pain control intraoperatively
Liposomal bupivacaine TAP block: Group will receive Liposomal bupivacaine TAP block (mixed with plain bupivacaine) intraoperatively during free flap breast reconstruction as part of the multimodal pain control.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.9 Years
STANDARD_DEVIATION 10.5 • n=59 Participants
|
51.1 Years
STANDARD_DEVIATION 8.7 • n=58 Participants
|
51.6 Years
STANDARD_DEVIATION 9.6 • n=117 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=59 Participants
|
58 Participants
n=58 Participants
|
117 Participants
n=117 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=59 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=117 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: During initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came firstVisual analog pain scale. Scores range from 0 to 10, 0 being no pain and 10 being worse pain that one experienced in their lifetime.
Outcome measures
| Measure |
Control - Plain Bupivacaine
n=59 Participants
Receives plain bupivacaine TAP block as part of multi-modal pain control intraoperatively
Bupivacain: Group will receive plain bupivacaine TAP block intraoperatively during free flap breast reconstruction as part of the multimodal pain control.
|
Experimental - Liposomal Bupivacaine
n=58 Participants
Receives plain bupivacaine + liposomal bupivacaine TAP block as part of multi-modal pain control intraoperatively
Liposomal bupivacaine TAP block: Group will receive Liposomal bupivacaine TAP block (mixed with plain bupivacaine) intraoperatively during free flap breast reconstruction as part of the multimodal pain control.
|
|---|---|---|
|
Post-op Pain Scores During Initial Hospitalization
|
4.3 score on a scale
Interval 2.7 to 5.7
|
3.3 score on a scale
Interval 2.2 to 5.0
|
PRIMARY outcome
Timeframe: during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came firsttotal amount of morphine milliequivalent
Outcome measures
| Measure |
Control - Plain Bupivacaine
n=59 Participants
Receives plain bupivacaine TAP block as part of multi-modal pain control intraoperatively
Bupivacain: Group will receive plain bupivacaine TAP block intraoperatively during free flap breast reconstruction as part of the multimodal pain control.
|
Experimental - Liposomal Bupivacaine
n=58 Participants
Receives plain bupivacaine + liposomal bupivacaine TAP block as part of multi-modal pain control intraoperatively
Liposomal bupivacaine TAP block: Group will receive Liposomal bupivacaine TAP block (mixed with plain bupivacaine) intraoperatively during free flap breast reconstruction as part of the multimodal pain control.
|
|---|---|---|
|
Post-op Narcotic Pain Medication Use During Hospitalization
|
55 MME
Interval 30.0 to 89.5
|
50 MME
Interval 20.0 to 90.0
|
SECONDARY outcome
Timeframe: during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came firsthospital length of stay
Outcome measures
| Measure |
Control - Plain Bupivacaine
n=59 Participants
Receives plain bupivacaine TAP block as part of multi-modal pain control intraoperatively
Bupivacain: Group will receive plain bupivacaine TAP block intraoperatively during free flap breast reconstruction as part of the multimodal pain control.
|
Experimental - Liposomal Bupivacaine
n=58 Participants
Receives plain bupivacaine + liposomal bupivacaine TAP block as part of multi-modal pain control intraoperatively
Liposomal bupivacaine TAP block: Group will receive Liposomal bupivacaine TAP block (mixed with plain bupivacaine) intraoperatively during free flap breast reconstruction as part of the multimodal pain control.
|
|---|---|---|
|
Length of Hospital Stay
|
2.1 Days
Standard Deviation 0.4
|
2.2 Days
Standard Deviation 0.6
|
Adverse Events
Control - Plain Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental - Liposomal 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place