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Clinical Trials/NCT04777591
NCT04777591
Completed
Phase 4

Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction

University of Virginia2 sites in 1 country117 target enrollmentMarch 1, 2021

Overview

Phase
Phase 4
Intervention
Bupivacain
Conditions
Postoperative Pain
Sponsor
University of Virginia
Enrollment
117
Locations
2
Primary Endpoint
Post-op Pain Scores During Initial Hospitalization
Status
Completed
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
December 28, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John Stranix

Assistant Professor

University of Virginia

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

Arms & Interventions

Control - plain bupivacaine

Receives plain bupivacaine TAP block as part of multi-modal pain control intraoperatively

Intervention: Bupivacain

Experimental - Liposomal bupivacaine

Receives plain bupivacaine + liposomal bupivacaine TAP block as part of multi-modal pain control intraoperatively

Intervention: Liposomal bupivacaine TAP block

Outcomes

Primary Outcomes

Post-op Pain Scores During Initial Hospitalization

Time Frame: During initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first

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.

Post-op Narcotic Pain Medication Use During Hospitalization

Time Frame: during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first

total amount of morphine milliequivalent

Secondary Outcomes

  • Length of Hospital Stay(during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first)

Study Sites (2)

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