Laparoscopic-assisted Versus Ultrasonography-guided Transversus Abdominis Plane Block in Laparoscopic Sleeve Gastrectomy

March 28, 2024 updated by: Amr Samir Wahdan, Cairo University
The transversus abdominis plane (TAP) block, whereby local anesthetic is injected between the internal oblique and transversus abdominis fascia to facilitate blockade of somatic afferents nerves, is an effective, non-narcotic adjunct incorporated into many ERAS protocols. We hypothesized that surgeon delivered LAP-TAPs would be non-inferior to anesthesia-delivered US-TAPs in terms of post-operative pain control

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Not Applicable

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

  • Egypt
      • Cairo, Egypt, 11562
        • Cairo University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Elective laparoscopic sleeve gastrectomy aging > 18years BMI > 40 kg/m2, ASA score I-III

Exclusion Criteria:

history of chronic opioid consumption suffering from contraindications to regional blocks suffering from allergy to study drugs, history of prior complex abdominal wall reconstruction

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: US-TAP group
Procedure: US-TAP
regional block team under ultrasound guidance
Active Comparator: LAPTAP group
Procedure: LAPTAP
performed TAP block under direct visualization with the laparoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morphine needed
Time Frame: UP TO 24 HOURE
mg
UP TO 24 HOURE

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
first analgesic request time
Time Frame: up to 24 hours
he time elapsed between the end of the operation till the first analgesic dose
up to 24 hours
patients' satisfaction
Time Frame: UP TO 24 HOURE
scale of 1-4 (1, poor; 2, acceptable; 3, satisfactory; and 4, excellent)
UP TO 24 HOURE
opioid-associated side effects
Time Frame: UP TO 24 HOURE
bradycardia and hypotesion
UP TO 24 HOURE

Collaborators and Investigators

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

Sponsor

Cairo University

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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2024-854

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Still working

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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