Laparoscopic Transversus Abdominis Plane Block Versus Erector Spinae Plane Block in Bariatric Surgery

NCT ID: NCT06564610

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-25

Study Completion Date

2025-01-09

Brief Summary

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The aim of this work is to compare the analgesic efficacy of laparoscopic transversus abdominis plane block, performed by the surgeon to ultrasound-guided erector spinae plane block, performed by the anesthetist, in patients with obesity undergoing bariatric surgery.

Detailed Description

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This is a randomized controlled trial which will include patients with obesity undergoing bariatric surgery. The patients will be randomly allocated into two groups: transversus abdominis plane block group and erector spinae plane block group. The block will be performed after induction of general anesthesia. Preoperative evaluation and preparation will include history-taking, laboratory investigation, fasting recommendations, and optimization of the medical status. The two groups will receive standard induction and maintenance of anesthesia. After the end of the operation, patients will receive standard care according to the local protocols and the enhanced recovery recommendations. Patients will be monitored according to the pain-related outcomes as well as hemodynamic parameters.

Conditions

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Pain, Postoperative Obesity Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Transversus abdominis block

Patients in this group will receive Transversus Abdominis block guided by the laparoscope at the beginning of surgery.

Group Type EXPERIMENTAL

Transversus abdominis block

Intervention Type PROCEDURE

The block will be performed by the surgeon by injecting local anesthetic at the beginning of surgery under the guidance of the laparoscope.

Bariatric surgery

Intervention Type PROCEDURE

Laparoscopic bariatric procedure will be performed

Endotracheal intubation

Intervention Type DEVICE

An endotracheal tube will be inserted as a part of general anesthesia to all patients

Propofol

Intervention Type DRUG

The patients will receive propofol for induction of anesthesia

Erector spinae block

Patients in this group will receive Erector Spinae block guided by the ultrasound after induction of anesthesia.

Group Type ACTIVE_COMPARATOR

Erector spinae block

Intervention Type PROCEDURE

The block will be performed by the anesthetist by injecting local anesthetic after induction of anesthesia under the guidance of the ultrasound.

Bariatric surgery

Intervention Type PROCEDURE

Laparoscopic bariatric procedure will be performed

Endotracheal intubation

Intervention Type DEVICE

An endotracheal tube will be inserted as a part of general anesthesia to all patients

Propofol

Intervention Type DRUG

The patients will receive propofol for induction of anesthesia

Interventions

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Transversus abdominis block

The block will be performed by the surgeon by injecting local anesthetic at the beginning of surgery under the guidance of the laparoscope.

Intervention Type PROCEDURE

Erector spinae block

The block will be performed by the anesthetist by injecting local anesthetic after induction of anesthesia under the guidance of the ultrasound.

Intervention Type PROCEDURE

Bariatric surgery

Laparoscopic bariatric procedure will be performed

Intervention Type PROCEDURE

Endotracheal intubation

An endotracheal tube will be inserted as a part of general anesthesia to all patients

Intervention Type DEVICE

Propofol

The patients will receive propofol for induction of anesthesia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with obesity undergoing laparoscopic bariatric surgery under general anesthesia.

Exclusion Criteria

* Allergy to local anaesthetic.
* Bleeding disorders.
* Obstructive sleep apnea.
* inability to understand the numerical rating scale for pain assessment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Hasanin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Hasanin, Professor

Role: PRINCIPAL_INVESTIGATOR

Professor of anesthesia

Locations

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Faculty of medicine, Cairo University.

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MD-292-2022

Identifier Type: -

Identifier Source: org_study_id

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