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

Phase 4

Completed

• Conditions: Breast Reconstruction; Transverse Abdominis Plane Block; Anesthesia
• Interventions: Drug: Regular bupivacaine; Drug: Liposomal bupivacaine

• Registration Number: NCT03700970
• Lead Sponsor: Vanderbilt University Medical Center

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-10-02
• Study First Submitted QC: 2018-10-06
• Study First Posted: 2018-10-09
• Study Start: 2019-06-13
• Primary Completion: 2021-03-15
• Study Completion: 2021-03-30
• Results First Submitted: 2021-11-26
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-24
• Last Update Submitted: 2021-12-24
• Results First Posted: 2022-01-24
• Last Update Posted: 2022-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP block with regular bupivacaine	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.
TAP block with liposomal bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)	Postoperative day (POD) 1 to 7	Amount of supplemental postoperative narcotic analgesia (both intravenous and oral) required by study groups in oral morphine equivalents

Secondary Outcome Measures

Name	Time	Method
Ambulation	1 day post op	Time to first ambulate post op (in days)
Non-narcotic Pain Medication Intake: Acetaminophen	Post op day 1 to 7	The total use of the non-narcotic pain medication Acetaminophen was recorded during hospitalization
Time to Return of Bowel Function	1 to 4 days post operation	Mean time in days at which patients had a return of bowel movement post op
Non Narcotic Pain Medication Intake: Cyclobenzaprine	Post op day 1 to 7	The total use of the non-narcotic pain medication Cyclobenzaprine was recorded during hospitalization
Pain Measure	Post operative day (POD) 1 to 7	Pain as measured by numeric rating scale ranging from 0 (no pain) to 10 (worst pain ever).
Time to First Opiate Use	0-29.8 hours post operation	Time from end of surgery to time of first opioid intake measured in hours
Length of Stay	1 to 4 days	Length of hospital stay post operatively
Non Narcotic Pain Medication Intake: Celebrex	post op day 1 to 7	The total use of the non-narcotic pain medication celebrex was recorded during hospitalization
Non Narcotic Pain Medication Intake: Gabapentin	Post op day 1 to 7	The total use of the non-narcotic pain medication gabapentin was recorded during hospitalization
Non Narcotic Pain Medication Intake: Ondansetron	Post op day 1 to 7	The total use of the non-narcotic pain medication ondansetron was recorded during hospitalization

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States