Comparing Local Anesthetics for TAP Block During Abdominally-based Free Flap for Breast Reconstruction

NCT03700970 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 180421
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the efficiency of transversus abominus plane (TAP) block using liposomal bupivacaine versus plain bupivacaine that is administered in the operating room under ultrasound guidance prior to the in patients undergoing abdominally-based free flap breast reconstruction at Vanderbilt University Medical Center.

Conditions

Breast Reconstruction; Anesthesia; Transverse Abdominis Plane Block

Outcome Measures

Primary Outcomes (1)

• Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)

  Amount of supplemental postoperative narcotic analgesia (both intravenous and oral) required by study groups in oral morphine equivalents

  Postoperative day (POD) 1 to 7

Secondary Outcomes (10)

• Pain Measure

  Post operative day (POD) 1 to 7

• Time to First Opiate Use

  0-29.8 hours post operation

• Time to Return of Bowel Function

  1 to 4 days post operation

• Length of Stay

  1 to 4 days

• Ambulation

  1 day post op

Study Arms (2)

TAP block with liposomal bupivacaine

EXPERIMENTAL

Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.

Drug: Liposomal bupivacaine

TAP block with regular bupivacaine

ACTIVE COMPARATOR

Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.

Drug: Regular bupivacaine

Interventions

Liposomal bupivacaine DRUG

20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.

Also known as: LB

TAP block with liposomal bupivacaine

Regular bupivacaine DRUG

20mL of 0.25% bupivacaine injected on each side.

Also known as: Bupivacaine HCl

TAP block with regular bupivacaine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18-85 years
• males or females
• plastic surgery for abdominally-based free flap breast reconstruction.

You may not qualify if:

• those not candidates for TAP blocks due to allergies to the medications (e.g., bupivacaine)
• those with anatomic contra-indications to performing a TAP block
• those unwilling to participate in follow-up assessments
• vulnerable populations
• chronic pain or associated diagnosis

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (1)

• Nguyen L, Glassman GE, Afshari A, Feng X, Shastri UD, Kaoutzanis C, McEvoy MD, Bansal V, Canlas C, Yao J, Higdon K, Perdikis G. Randomized Controlled Trial Comparing Liposomal to Plain Bupivacaine in the Transversus Abdominis Plane for DIEP Flap Breast Reconstruction. Plast Reconstr Surg. 2024 Mar 1;153(3):543-551. doi: 10.1097/PRS.0000000000010710. Epub 2023 May 22.

  PMID: 37220228 DERIVED

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

If a patient was unable to be reached, they were given a log to record pain scores and medication intake. There may be a recall bias if those patients were unable to adhere to the protocol to record daily and retroactively logged their scores and number of tablets taken. Another limitation is the reliance of certain outcomes on subjective data (i.e. Numeric Pain Scale scores).

Results Point of Contact

• Title: Dr. Galen Perdikis
• Organization: Vanderbilt university medical center

galen.perdikis@vumc.org

+1 (615) 936-0198

Study Officials

• Galen Perdikis, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants and plastic surgeons will be blinded to the study treatment arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair and Professor of Surgery Department of Plastic Surgery

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 9, 2018
• Study Start: June 13, 2019
• Primary Completion: March 15, 2021
• Study Completion: March 30, 2021
• Last Updated: January 24, 2022
• Results First Posted: January 24, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)