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Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction

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University of Virginia

Status and phase

Completed
Phase 4

Conditions

Postoperative Pain
Breast Reconstruction

Treatments

Drug: Liposomal bupivacaine TAP block
Drug: Bupivacain

Study type

Interventional

Funder types

Other

Identifiers

NCT04777591
HSR210033

Details and patient eligibility

About

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.

Enrollment

117 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

117 participants in 2 patient groups

Control - plain bupivacaine
Active Comparator group
Description:
Receives plain bupivacaine TAP block as part of multi-modal pain control intraoperatively
Treatment:
Drug: Bupivacain
Experimental - Liposomal bupivacaine
Experimental group
Description:
Receives plain bupivacaine + liposomal bupivacaine TAP block as part of multi-modal pain control intraoperatively
Treatment:
Drug: Liposomal bupivacaine TAP block

Trial documents
1

Trial contacts and locations

2

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Central trial contact

Rachel H Park, MD

Data sourced from clinicaltrials.gov

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