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

NCT ID: NCT03700970

Last Updated: 2022-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-13
• Study Completion Date: 2021-03-30

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.

Detailed Description

Transversus Abdominis Plane (TAP) blocks are commonly used as part of Enhanced Recovery After Surgery (ERAS) pathway. This prospective, double-blinded, randomized control trial compares post-operative pain and narcotic consumption after deep inferior epigastric artery perforator (DIEP) breast reconstruction with liposomal bupivacaine (LB) compared to bupivacaine hydrochloride (BHCl). Subjects undergoing DIEP flaps were randomly assigned LB or BHCl, performed using ultrasound-guided TAP block technique pre-procedurally. Primary outcomes were postoperative narcotic analgesia required in oral morphine equivalents (OME) from postoperative day (POD) 0 to 7. Secondary outcomes included POD 1-7 pain Numeric Rating Scale (NRS), non-narcotic pain medication consumption, time to first narcotic use, return of bowel function, and length of stay (LOS).

Conditions

Breast Reconstruction; Anesthesia; Transverse Abdominis Plane Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TAP block with liposomal bupivacaine

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.

Group Type: EXPERIMENTAL

Liposomal bupivacaine

Intervention Type: 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.

TAP block with regular bupivacaine

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.

Group Type: ACTIVE_COMPARATOR

Regular bupivacaine

Intervention Type: DRUG

20mL of 0.25% bupivacaine injected on each side.

Interventions

Liposomal bupivacaine

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.

Intervention Type: DRUG

Regular bupivacaine

20mL of 0.25% bupivacaine injected on each side.

Intervention Type: DRUG

Other Intervention Names

LB; Bupivacaine HCl

Eligibility Criteria

Inclusion Criteria

1. age between 18-85 years

2. males or females

3. plastic surgery for abdominally-based free flap breast reconstruction.

Exclusion Criteria

1. those not candidates for TAP blocks due to allergies to the medications (e.g., bupivacaine)

2. those with anatomic contra-indications to performing a TAP block

3. those unwilling to participate in follow-up assessments

4. vulnerable populations

5. chronic pain or associated diagnosis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Galen Perdikis

Chair and Professor of Surgery Department of Plastic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Galen Perdikis, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37220228 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

180421

Identifier Type: -

Identifier Source: org_study_id