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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-29

Study Completion Date

2023-12-07

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.

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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.

Conditions

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Morbid Obesity Bariatric Surgery Candidate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a 2-arm parallel single blinded randomized equivalency, single-center, clinical trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Patients will be blinded to type of Transversus Abdominis Plane (TAP) block used.

Study Groups

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Bupivacaine only

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.

Group Type ACTIVE_COMPARATOR

Bupivacaine Injection

Intervention Type DRUG

Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with plain bupivacaine

Liposomal Bupivacaine

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.

Group Type EXPERIMENTAL

Liposomal bupivacaine

Intervention Type DRUG

Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with liposomal bupivacaine

Interventions

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Liposomal bupivacaine

Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with liposomal bupivacaine

Intervention Type DRUG

Bupivacaine Injection

Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with plain bupivacaine

Intervention Type DRUG

Other Intervention Names

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Exparel Plain bupivacaine

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No