Clinical trial NCT03700970: Comparing Local Anesthetics for TAP Block During Abdominally-based Free Flap for Breast Reconstruction
Official title: Double-Blinded Randomized Control Trial Comparing Liposomal Bupivacaine and Bupivacaine Hydrochloride in Transversus Abdominis Plane Blocks Prior To DIEP Flap for Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Reconstruction
Anesthesia
Transverse Abdominis Plane Block
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)
timeFrame: Postoperative day (POD) 1 to 7
Secondary outcomes:
measure: Pain Measure
timeFrame: Post operative day (POD) 1 to 7
measure: Time to First Opiate Use
timeFrame: 0-29.8 hours post operation
measure: Time to Return of Bowel Function
timeFrame: 1 to 4 days post operation
measure: Length of Stay
timeFrame: 1 to 4 days
measure: Ambulation
timeFrame: 1 day post op
measure: Non-narcotic Pain Medication Intake: Acetaminophen
timeFrame: Post op day 1 to 7
measure: Non Narcotic Pain Medication Intake: Cyclobenzaprine
timeFrame: Post op day 1 to 7
measure: Non Narcotic Pain Medication Intake: Gabapentin
timeFrame: Post op day 1 to 7
measure: Non Narcotic Pain Medication Intake: Celebrex
timeFrame: post op day 1 to 7
measure: Non Narcotic Pain Medication Intake: Ondansetron
timeFrame: Post op day 1 to 7
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Galen Perdikis, MD
role: PRINCIPAL_INVESTIGATOR
References: