Unilateral TAP Block for Laparoscopic Gastric Sleeve Surgery

September 20, 2022 updated by: Christina Jeng, Icahn School of Medicine at Mount Sinai

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 11217
        • Mount Sinai Brooklyn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Saline
Patients will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with normal saline on the ipsilateral side as the extraction site.
Drug: Saline
40 mL sterile normal saline
ACTIVE_COMPARATOR: Bupivacaine
Patients will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with bupivacaine on the ipsilateral side as the extraction site.
Drug: Bupivacaine
40 mL 0.25% bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of 24 Hour Opioid Consumption
Time Frame: 24 Hours postoperative
Amount of intravenous (IV) opioid consumption within 24-hour period
24 Hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of Intraoperative IV Opioid Consumption
Time Frame: average 2-3 Hours
Amount of intravenous opioid consumption during the surgery
average 2-3 Hours
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.
24 Hours postoperative
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
24 Hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 10, 2018

Primary Completion (ACTUAL)

March 25, 2021

Study Completion (ACTUAL)

March 25, 2021

Study Registration Dates

First Submitted

February 20, 2019

First Submitted That Met QC Criteria

February 26, 2019

First Posted (ACTUAL)

February 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 17, 2022

Last Update Submitted That Met QC Criteria

September 20, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 18-1886

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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