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Completed

NCT Number: NCT05537883

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

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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Key information

Conditions

Morbid Obesity Bariatric Surgery Candidate Bites and Stings Body Weight Chemically-Induced Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Poisoning Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liposomal bupivacaine

Drug

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

Other names: Exparel

Bupivacaine Injection

Drug

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

Other names: Plain bupivacaine

Primary outcomes

  1. Mean 24 Hour Visual Analogue Scale (VAS) Pain Score

    Time frame: Hour 24

    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.

Secondary outcomes

  1. Mean Visual Analogue Scale (VAS) Pain Scores

    Time frame: Hours,12, 48, and 72

    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

  2. Mean Average Morphine Equivalences

    Time frame: Day 3

    Morphine milligram equivalences consumed during hospital stay

  3. Morphine Equivalences - Week 1

    Time frame: Week 1

    Morphine milligram equivalences prescribed and consumed as measured at one week follow up clinic visit

  4. Post-operative Nausea and Vomiting (PONV)

    Time frame: Week 1

    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)

  5. Length of Hospital Stay

    Time frame: Day 3

    Hospital length of stay in hours

  6. Patient Satisfaction Scores

    Time frame: Day 30

    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."

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Acronym: TAP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2022
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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