Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction

Last updated: August 21, 2024
Sponsor: University of Virginia
Overall Status: Completed

Phase

4

Condition

Breast Reconstruction

Pain

Chronic Pain

Treatment

Liposomal bupivacaine TAP block

Bupivacain

Clinical Study ID

NCT04777591
HSR210033
  • Ages > 18
  • Female

Study 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

Inclusion Criteria:

  • All female patients who are 18 years or older who will undergo unilateral orbilateral abdomen-based free flap breast reconstruction at UVA Medical Center

Exclusion

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

Study Design

Total Participants: 117
Treatment Group(s): 2
Primary Treatment: Liposomal bupivacaine TAP block
Phase: 4
Study Start date:
March 01, 2021
Estimated Completion Date:
December 28, 2022

Connect with a study center

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • University of Virginia Medical Center

    Charlottesville, Virginia 22902
    United States

    Site Not Available

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