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OpenTrials
Completed

NCT Number: NCT03856788

Unilateral TAP Block for Laparoscopic Gastric Sleeve Surgery

The study team will be assessing if the unilateral subcostal transversus abdominis plane (TAP) block can decrease pain and improve outcomes following laparoscopic sleeve gastrectomy surgeries.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mount Sinai Brooklyn

New York, 11217, United States

About this study

This study will be a double-blinded randomized control trial. Patients will be randomized into one of two groups. Patients in Group 1 will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with 40 mL 0.25% bupivacaine on the ipsilateral side as the extraction site. Patients in Group 2 will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with 40 mL sterile normal saline on the ipsilateral side as the extraction site. Investigators will be blinded to the randomization of these patients. Following performance of these blocks, patients will receive standard care for the surgery as well as during the postoperative recovery period. Data will be obtained from the EPIC electronic medical record, and from the anesthesia computer record. Patients will be asked postoperatively to assess items such as their nausea and pain scores. Patients will also be contacted by phone within 1-2 days of discharge to obtain analgesic satisfaction scores. This data will be collected on the Redcap server.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults 18-80 years old
  • Candidate for general anesthesia
  • Undergoing laparoscopic sleeve gastrectomy
  • Patients of participating surgeons

Exclusion criteria

  • Prior bariatric surgery of any kind
  • Previous abdominoplasty
  • Allergy or intolerance to one of the study medications
  • ASA > 4
  • Chronic opioid use (taking opioids for longer than 3 months or daily oral morphine equivalent of >5mg/day for one month)
  • History of alcohol/drug abuse
  • History of hepatic or renal insufficiency
  • Patient refusal

Treatment and study plan

Saline

Drug

40 mL sterile normal saline

Bupivacaine

Drug

40 mL 0.25% bupivacaine

Primary outcomes

  1. Amount of 24 Hour Opioid Consumption

    Time frame: 24 Hours postoperative

    Amount of intravenous (IV) opioid consumption within 24-hour period

Secondary outcomes

  1. Amount of Intraoperative IV Opioid Consumption

    Time frame: average 2-3 Hours

    Amount of intravenous opioid consumption during the surgery

  2. Number of Participants Asked Area of Pain on the Body After Surgery

    Time frame: 24 Hours postoperative

    Patients asked for the areas of pain (right upper quadrant (RUQ), left upper quadrant, (LUQ) right lower quadrant (RLQ), or left lower quadrant (LLQ), diffuse and epigastric) after surgery.

  3. Number of Participants Who Answered Yes to Having Presence of Nausea After Surgery

    Time frame: 24 Hours postoperative

    Number of participants who answered yes to having presence of nausea after surgery

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Effect of Unilateral Ultrasound-Guided Subcostal Transversus Abdominis Plane Block in Patients Undergoing Laparoscopic Sleeve Gastrectomy

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 27, 2019
Registry last updated
Oct 17, 2022

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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