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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Breast Reconstruction, Anesthesia, Transverse Abdominis Plane Block

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: Regular bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP block with liposomal bupivacaine<br>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<br>* 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.<br>* Other names: LB;|
| Active Comparator: TAP block with regular bupivacaine<br>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<br>* 20mL of 0.25% bupivacaine injected on each side.<br>* Other names: Bupivacaine HCl;|

What is the study measuring?
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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 |