Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction

Phase 4

Completed

Conditions: Postoperative Pain
Breast Reconstruction

Interventions: Drug: Liposomal bupivacaine TAP block
Drug: Bupivacain

Registration Number: NCT04777591

Lead Sponsor: University of Virginia

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 117

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental - Liposomal bupivacaine	Liposomal bupivacaine TAP block	Receives plain bupivacaine + liposomal bupivacaine TAP block as part of multi-modal pain control intraoperatively
Control - plain bupivacaine	Bupivacain	Receives plain bupivacaine TAP block as part of multi-modal pain control intraoperatively

Primary Outcome Measures

Name	Time	Method
Post-op Pain Scores During Initial Hospitalization	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	during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first	total amount of morphine milliequivalent

Secondary Outcome Measures

Name	Time	Method
Length of Hospital Stay	during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first	hospital length of stay

Trial Locations

Locations (2): University of Virginia
🇺🇸
Charlottesville, Virginia, United States
University of Virginia Medical Center
🇺🇸
Charlottesville, Virginia, United States