Postoperative Analgesia of TAP Block for Laparoscopic Sleeve Gastrectomy (TAP)

November 26, 2023 updated by: Ismail Mohamed Abdelgawad Ahmed, Al-Azhar University

Postoperative Efficacy of Subcostal TAP Block in Laparoscopic Sleeve Gastrectomy Surgery: a Randomized Controlled Trial

many methods were considered to control postoperative pain in laparoscopic bariatic surgery including non steroidal anti-inflammatory drugs, opioids and neuraxial block

but subcostal (TAP) block has provided good analgesic effect when used as a part of multimodal analgesia in bariatric surgery due to lack of visceral block

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Since long time opioid have been used to control postoperative pain in bariatric surgery However, an increasing awareness of opioid-related adverse events, including respiratory depression, paralytic ileums, and sedation, constipation has led to a shift towards utilizing opioid-sparing techniques for postoperative analgesia As neuroaxial block and ultrasound guided nerve blocks

As the transverse abdominis plane (TAP) block which is of increasing interest nowadays (Basaran B, et al 2015)

The ultrasound-guided oblique SCTAP block, first described by Hebbard et al., has the potential to provide analgesia for both upper and lower abdominal surgery. There is a growing consensus that the SCTAP block provides better analgesia for upper abdominal incisions

The TAP block via various approaches provides some advantages over neuraxial anesthesia (Ganapathy Set al 2015). For example, TAP blocks are associated with a lower use of intraoperative phenylephrine and a lesser degree of intraoperative blood pressure changes. The SCTAP block may be utilized in cases in which neuraxial anesthesia is contraindicated, such as patients with coagulation issues or infection at the epidural puncture site. Although the SCTAP block provides sensory blockade of the abdominal wall, it is lacking in coverage of visceral pain (Lissauer J,et al 2014).

The lack of visceral pain analgesia may require the use of additional methods of postoperative pain control such as intravenous opioids or non-narcotic analgesics.

Study Type

Interventional

Enrollment (Estimated)

100

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 Contact

Study Contact Backup

Study Locations

  • Egypt
    • Naser City
      • Cairo, Naser City, Egypt, 11811
        • Recruiting
        • Al Azhar University
        • Contact:

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 20-60 years
  • ASA Ι-ΙΙ
  • BMI >35

Exclusion Criteria:

  • Patient refusal.
  • Allergy to study drugs.
  • Infection at site of injection.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TAP group
patients candidate for laparoscopic sleeve gastrectomy to receive GA and subcostal TAP block to control postoperative pain and minimize opioid consumption
Other: subcostal TAP block
Comparison between subcostal TAP block and opioids for postoperative pain after laparscopic sleeve gastrectomy
No Intervention: Control group
healthy controls candidate for laparoscopic sleeve gastrectomy to receive GA only opioids were used

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain control
Time Frame: 9 months
by using VAS score
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative 24 hour opioid consumption
Time Frame: 9 months
collecting total doses of opioids consumed in the first 24 hours postoperative in cmparison to the other group
9 months
postoperative nausea and vomiting
Time Frame: 9 months
recording incidence, frequency and severity
9 months

Collaborators and Investigators

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

Sponsor

Al-Azhar University

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

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)

January 30, 2023

Primary Completion (Estimated)

November 30, 2023

Study Completion (Estimated)

December 15, 2023

Study Registration Dates

First Submitted

November 26, 2023

First Submitted That Met QC Criteria

November 26, 2023

First Posted (Actual)

December 5, 2023

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 26, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAP block

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD are planned to be coded for privacy protection

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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