Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction

NCT04777591 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HSR210033
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Pain; Breast Reconstruction

Keywords

TAP block; Regional block; ERAS; liposomal bupivacaine; free flap

Outcome Measures

Primary Outcomes (2)

• Post-op Pain Scores During Initial Hospitalization

  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.

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

• Post-op Narcotic Pain Medication Use During Hospitalization

  total amount of morphine milliequivalent

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

Secondary Outcomes (1)

• Length of Hospital Stay

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

Study Arms (2)

Control - plain bupivacaine

ACTIVE COMPARATOR

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

Drug: Bupivacain

Experimental - Liposomal bupivacaine

EXPERIMENTAL

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

Drug: Liposomal bupivacaine TAP block

Interventions

Liposomal bupivacaine TAP block DRUG

Group will receive Liposomal bupivacaine TAP block (mixed with plain bupivacaine) intraoperatively during free flap breast reconstruction as part of the multimodal pain control.

Experimental - Liposomal bupivacaine

Bupivacain DRUG

Group will receive plain bupivacaine TAP block intraoperatively during free flap breast reconstruction as part of the multimodal pain control.

Control - plain bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (2)

University of Virginia Medical Center

Charlottesville, Virginia, 22902, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• Park RH, Chou J, DeVito RG, Elmer A, Hollenbeck ST, Campbell CA, Stranix JT. Effectiveness of Liposomal Bupivacaine Transversus Abdominis Plane Block in DIEP Flap Breast Reconstruction: A Randomized Controlled Trial. Plast Reconstr Surg. 2024 Oct 1;154(4S):52S-59S. doi: 10.1097/PRS.0000000000011326. Epub 2024 Sep 20.

  PMID: 38315156 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: John T Stranix, MD
• Organization: University of Virginia

jts3v@uvahealth.org

434-924-5078

Study Officials

• John Stranix, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Control group: TAP block with plain bupivacaine Intervention group: TAP block with plain bupivacaine + liposomal bupivacaine

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 2, 2021
• Study Start: March 1, 2021
• Primary Completion: December 28, 2022
• Study Completion: December 28, 2022
• Last Updated: August 23, 2024
• Results First Posted: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)