Transversus Abdominis Plane (TAP) Block Using Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients

Study Overview
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Brief Summary
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To investigate if laparoscopic Transversus Abdominis Plane (TAP) block using plain bupivacaine is equivalent to using liposomal bupivacaine in patients undergoing metabolic and bariatric surgery. The study will see if the plain bupivacaine group will be equivalent in terms of length of stay, Morphine Milligram Equivalents, Pain scores and patient satisfaction, but cost less.

Detailed Description
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Compared to only Bupivacaine administered via TAP block, the study will investigate the analgesia effects to patients undergoing metabolic and bariatric surgery receiving TAP block with a Liposomal Bupivacaine mixture. To determine if patients undergoing metabolic and bariatric surgery receiving TAP block with a Liposomal Bupivacaine results in pain scores, as measured by visual analogic scale (VAS), that are equivalent compared to patients receiving TAP block with Bupivacaine only. Compared to TAP block with Bupivacaine only, the study will compare opioid consumption, and other effect differences to patients undergoing metabolic and bariatric surgery receiving TAP block with Liposomal Bupivacaine. The study will explore other effects, including pain score at 48 hours, and 72 hours after surgery, total opioid consumption required post op during their one-week post op visit as measured in morphine equivalences.

Official Title
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Single Blinded Randomized Trial of Transversus Abdominis Plane Block Using Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients

Conditions
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Morbid Obesity, Bariatric Surgery Candidate

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: Bupivacaine Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years Participants who can give written informed consent and willing to comply with all study-related procedures. Patients undergoing primary sleeve gastrectomy or roux-en-y gastric bypass Exclusion Criteria: Patients undergoing duodenal switch procedures Patients undergoing concomitant hiatal hernia repair or ventral hernia repair or cholecystectomy at time of primary metabolic surgery Patients with chronic opioid use

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: This study is a 2-arm parallel single blinded randomized equivalency, single-center, clinical trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine only<br>Active control group patients receive Transversus Abdominis Plane (TAP) block with a Bupivacaine only mixture, containing 50 mL 0.5% Bupivacaine, and 100 mL normal saline solution. | Drug: Bupivacaine Injection<br>* Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with plain bupivacaine<br>* Other names: Plain bupivacaine;|
| Experimental: Liposomal Bupivacaine<br>Study group patients will receive Transversus Abdominis Plane (TAP) block with a Liposomal Bupivacaine mixture, containing 20 mL Liposomal Bupivacaine, 30 mL 0.5% Bupivacaine, and 100 mL normal saline solution. | Drug: Liposomal bupivacaine<br>* Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with liposomal bupivacaine<br>* Other names: Exparel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 Hour Visual Analogue Scale (VAS) Pain Score | Pain score at 24 hours post-operative, using visual analogue scale (VAS), ranging from 1 to 10. One indicates no pain, and 10 indicates the worst pain one could imagine. | Hour 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) Pain Scores | Pain score at 12 hours, 48 hours, and 72 hours post-operative, using visual analogue scale (VAS), ranging from 1 to 10. One indicates no pain, and 10 indicates the worst pain one could imagine | Hours,12, 48, and 72 | 
| Morphine Equivalences - Immediate | Morphine milligram equivalences consumed during hospital stay | Hour 24 | 
| Morphine Equivalences - Week 1 | Morphine milligram equivalences prescribed and consumed as measured at one week follow up clinic visit | Week 1 | 
| Post-operative nausea and vomiting (PONV) | Post-operative nausea and vomiting (PONV) measured by a numerical score (1: no nausea or vomiting, 2: some nausea no vomiting, 3: nausea and vomiting) | Week 1 | 
| Length of Hospital Stay | Hospital length of stay in hours | Day 3 | 
| Patient Satisfaction Scores | Patient Satisfaction score based on daily postop online surveys - These parameters will be scored via SeamlessMD on a phone application, as well as paper and pen on a standardized reporting form for patients less comfortable using technology - scored on a scale of 0-10, with 0 being worst surgeon possible and 10 being best surgeon possible. | Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transversus Abdominis Plane (TAP) block, Bupivacaine, Liposomal bupivacaine