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Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction
Phase 4 trial testing Liposomal bupivacaine TAP block in Postoperative Pain in 117 participants. Completed in 28 December 2022.
| Lead sponsor | University of Virginia |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 117 |
| Start date | 1 March 2021 |
| Primary completion | 28 December 2022 |
| Estimated completion | 28 December 2022 |
| Sites | 2 locations across United States |
University of Virginia
18 and older, female only, with Postoperative Pain or Breast Reconstruction. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Control - Plain Bupivacaine | 4.3 | 2.7 – 5.7 |
| Experimental - Liposomal Bupivacaine | 3.3 | 2.2 – 5.0 |
total amount of morphine milliequivalent
| Group | Value | 95% CI |
|---|---|---|
| Control - Plain Bupivacaine | 55 | 30 – 89.5 |
| Experimental - Liposomal Bupivacaine | 50 | 20 – 90 |
hospital length of stay
| Group | Value | 95% CI |
|---|---|---|
| Control - Plain Bupivacaine | 2.1 | ± 0.4 |
| Experimental - Liposomal Bupivacaine | 2.2 | ± 0.6 |
Transversus Abdominis Plane (TAP) block is a useful tool in pain management after abdominal surgery. It is a regional nerve block that targets T6-L1 thoracolumbar nerves running in the plane between internal oblique and transversus abdominis muscle. It is shown to help with post-operative pain management, reducing pain scores and narcotic pain medication use, as well as promoting earlier return to activity and recovery. TAP block became a very popular, safe, and effective therapeutic adjunct for many different abdominal surgeries ranging from obstetric procedures to general surgery procedures like colorectal surgery. Furthermore, it is used in plastic surgery procedures such as Deep Inferior Epigastric Perforator (DIEP) free flap or Transverse Rectus Abdominis Myocutaneous (TRAM) flap, as they involve extensive amount of abdominal soft tissue incision. Previous studies have shown that TAP block in these procedures significantly reduce post-op pain and narcotic pain medication use. More recently, Exparel (liposomal bupivacaine) has risen to spotlight for providing a longer, sustained local anesthesia. Various surgical disciplines have adopted this agent as part of their pain management protocol. However, there are no literatures that describe the effect of TAP block using Exparel for breast free flap population. The study hypothesize that delivering TAP block with Exparel (vs. plain bupivacaine) will provide longer regional blocking effect, hence aiding in pain control and recovery postoperatively. The investigators will be analyzing postop narcotic pain medication requirement and pain scores to look into this question.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing