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

Not Applicable

Completed

• Conditions: Analgesia; Pain, Postoperative; Obesity
• Interventions: Procedure: Erector spinae block; Procedure: Transversus abdominis block; Procedure: Bariatric surgery; Device: Endotracheal intubation; Drug: Propofol

• Registration Number: NCT06564610
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-16
• Study First Submitted QC: 2024-08-19
• Study First Posted: 2024-08-21
• Study Start: 2024-08-25
• Primary Completion: 2025-01-05
• Study Completion: 2025-01-09
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector spinae block	Erector spinae block	Patients in this group will receive Erector Spinae block guided by the ultrasound after induction of anesthesia.
Erector spinae block	Bariatric surgery	Patients in this group will receive Erector Spinae block guided by the ultrasound after induction of anesthesia.
Erector spinae block	Endotracheal intubation	Patients in this group will receive Erector Spinae block guided by the ultrasound after induction of anesthesia.
Transversus abdominis block	Transversus abdominis block	Patients in this group will receive Transversus Abdominis block guided by the laparoscope at the beginning of surgery.
Transversus abdominis block	Bariatric surgery	Patients in this group will receive Transversus Abdominis block guided by the laparoscope at the beginning of surgery.
Transversus abdominis block	Endotracheal intubation	Patients in this group will receive Transversus Abdominis block guided by the laparoscope at the beginning of surgery.
Transversus abdominis block	Propofol	Patients in this group will receive Transversus Abdominis block guided by the laparoscope at the beginning of surgery.
Erector spinae block	Propofol	Patients in this group will receive Erector Spinae block guided by the ultrasound after induction of anesthesia.

Primary Outcome Measures

Name	Time	Method
Numerical rating scale	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 Outcome Measures

Name	Time	Method
Consumption of analgesia	24 hours after surgery	This is the total consumption of nalbuphine by the patient measured in milligrams
Heart rate	24 hours after surgery	This is the number of heart beats measured as frequency of heart beats in one minute.
Vomiting	24 hours	This is the incidence of vomiting after surgery measured as the frequency of patients with vomiting.
Systolic blood pressure	24 hours after surgery	This is the systolic arterial blood pressure measured in mmHg.
Diastolic blood pressure	24 hours	This is the diastolic arterial blood pressure measured in mmHg.

Trial Locations

Locations (1)

Faculty of medicine, Cairo University.; 🇪🇬 Cairo, Egypt