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

Vanderbilt University Medical Center60 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Breast Reconstruction Anesthesia Transverse Abdominis Plane Block

Interventions

Liposomal bupivacaineDRUG

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.

Regular bupivacaineDRUG

20mL of 0.25% bupivacaine injected on each side.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

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

Time frame: Postoperative day (POD) 1 to 7

Secondary Outcomes

Pain Measure

Pain as measured by numeric rating scale ranging from 0 (no pain) to 10 (worst pain ever).

Time frame: Post operative day (POD) 1 to 7

Time to First Opiate Use

Time from end of surgery to time of first opioid intake measured in hours

Time frame: 0-29.8 hours post operation

Time to Return of Bowel Function

Mean time in days at which patients had a return of bowel movement post op

Time frame: 1 to 4 days post operation

Length of Stay

Length of hospital stay post operatively

Time frame: 1 to 4 days

Ambulation

Time to first ambulate post op (in days)

Time frame: 1 day post op

Non-narcotic Pain Medication Intake: Acetaminophen

The total use of the non-narcotic pain medication Acetaminophen was recorded during hospitalization

Time frame: Post op day 1 to 7

Non Narcotic Pain Medication Intake: Cyclobenzaprine

The total use of the non-narcotic pain medication Cyclobenzaprine was recorded during hospitalization

Data from ClinicalTrials.gov

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