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

Double-Blinded Randomized Control Trial Comparing Liposomal Bupivacaine and Bupivacaine Hydrochloride in Transversus Abdominis Plane Blocks Prior To DIEP Flap for Breast Reconstruction

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Breast Reconstruction; Transverse Abdominis Plane Block
• Intervention / Treatment: Drug: Liposomal bupivacaine; Drug: Regular bupivacaine

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).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: LB
Active Comparator: 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.	Drug: Regular bupivacaine; 20mL of 0.25% bupivacaine injected on each side.; Other Names: Bupivacaine HCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Measure	Pain as measured by numeric rating scale ranging from 0 (no pain) to 10 (worst pain ever).	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	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	1 to 4 days post operation
Length of Stay	Length of hospital stay post operatively	1 to 4 days
Ambulation	Time to first ambulate post op (in days)	1 day post op
Non-narcotic Pain Medication Intake: Acetaminophen	The total use of the non-narcotic pain medication Acetaminophen was recorded during hospitalization	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	Post op day 1 to 7
Non Narcotic Pain Medication Intake: Gabapentin	The total use of the non-narcotic pain medication gabapentin was recorded during hospitalization	Post op day 1 to 7
Non Narcotic Pain Medication Intake: Celebrex	The total use of the non-narcotic pain medication celebrex was recorded during hospitalization	post op day 1 to 7
Non Narcotic Pain Medication Intake: Ondansetron	The total use of the non-narcotic pain medication ondansetron was recorded during hospitalization	Post op day 1 to 7

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Galen Perdikis, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2019
• Primary Completion (Actual): March 15, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 6, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): January 24, 2022
• Last Update Submitted That Met QC Criteria: December 24, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 180421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No