Double-Blinded Randomized Control Trial Comparing Liposomal Bupivacaine and Bupivacaine Hydrochloride in Transversus Abdominis Plane Blocks Prior To DIEP Flap for Breast Reconstruction
Overview
- Phase
- Phase 4
- Intervention
- Liposomal bupivacaine
- Conditions
- Breast Reconstruction
- Sponsor
- Vanderbilt University Medical Center
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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).
Investigators
Galen Perdikis
Chair and Professor of Surgery Department of Plastic Surgery
Vanderbilt University Medical Center
Eligibility Criteria
Inclusion Criteria
- •age between 18-85 years
- •males or females
- •plastic surgery for abdominally-based free flap breast reconstruction.
Exclusion Criteria
- •those not candidates for TAP blocks due to allergies to the medications (e.g., bupivacaine)
- •those with anatomic contra-indications to performing a TAP block
- •those unwilling to participate in follow-up assessments
- •vulnerable populations
- •chronic pain or associated diagnosis
Arms & Interventions
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.
Intervention: Liposomal bupivacaine
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.
Intervention: Regular bupivacaine
Outcomes
Primary Outcomes
Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)
Time Frame: 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 Outcomes
- Ambulation(1 day post op)
- Non-narcotic Pain Medication Intake: Acetaminophen(Post op day 1 to 7)
- Time to Return of Bowel Function(1 to 4 days post operation)
- Non Narcotic Pain Medication Intake: Cyclobenzaprine(Post op day 1 to 7)
- Pain Measure(Post operative day (POD) 1 to 7)
- Time to First Opiate Use(0-29.8 hours post operation)
- Length of Stay(1 to 4 days)
- Non Narcotic Pain Medication Intake: Celebrex(post op day 1 to 7)
- Non Narcotic Pain Medication Intake: Gabapentin(Post op day 1 to 7)
- Non Narcotic Pain Medication Intake: Ondansetron(Post op day 1 to 7)