Phase 4
N=117
Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction
Postoperative Pain · Breast Reconstruction
Bottom Line
View on ClinicalTrials.gov: NCT04777591 ↗Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Post-op Pain Scores During Initial Hospitalization — 4.3; 3.3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Liposomal bupivacaine TAP block (Drug); Bupivacain (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Virginia
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-op Pain Scores During Initial Hospitalization |
4.3; 3.3 | — |
| PRIMARY Post-op Narcotic Pain Medication Use During Hospitalization |
55; 50 | — |
| SECONDARY Length of Hospital Stay |
2.1; 2.2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- All female patients who are 18 years or older who will undergo unilateral or bilateral abdomen-based free flap breast reconstruction at UVA Medical Center
Exclusion Criteria
- Subjects with ages <18 years
- Allergy to local anesthetic
- Inability to tolerate standard postoperative pain management regimen (Tylenol, Toradol, and Oxycodone PRN) for any reason
- Subjects who cannot read or understand English
- Subjects who are pregnant
Data sourced from ClinicalTrials.gov (NCT04777591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.