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Clinical Trials/NCT06564610
NCT06564610
Completed
N/A

Laparoscopic Transversus Abdominis Plane Block Versus Erector Spinae Plane Block in Obese Patients Undergoing Bariatric Surgery: a Randomized Controlled Trial

Cairo University1 site in 1 country96 target enrollmentAugust 25, 2024

Overview

Phase
N/A
Intervention
Bariatric surgery
Conditions
Pain, Postoperative
Sponsor
Cairo University
Enrollment
96
Locations
1
Primary Endpoint
Numerical rating scale
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
August 25, 2024
End Date
January 9, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Hasanin

Professor

Cairo University

Eligibility Criteria

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.

Arms & Interventions

Transversus abdominis block

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

Intervention: Bariatric surgery

Transversus abdominis block

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

Intervention: Endotracheal intubation

Transversus abdominis block

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

Intervention: Transversus abdominis block

Transversus abdominis block

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

Intervention: Propofol

Erector spinae block

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

Intervention: Erector spinae block

Erector spinae block

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

Intervention: Bariatric surgery

Erector spinae block

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

Intervention: Endotracheal intubation

Erector spinae block

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

Intervention: Propofol

Outcomes

Primary Outcomes

Numerical rating scale

Time Frame: 24 hours after surgery

This is a scale for pain assessment which ranges between 0 and 10 with the highest level of pain having score 10 and lowest level of pain having score 0

Secondary Outcomes

  • Consumption of analgesia(24 hours after surgery)
  • Heart rate(24 hours after surgery)
  • Vomiting(24 hours)
  • Systolic blood pressure(24 hours after surgery)
  • Diastolic blood pressure(24 hours)

Study Sites (1)

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