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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Pain, Postoperative; Analgesia
• Intervention / Treatment: Procedure: Bariatric surgery; Device: Endotracheal intubation; Procedure: Transversus abdominis block; Drug: Propofol; Procedure: Erector spinae block

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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11432
    • Faculty of medicine, Cairo University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transversus abdominis block; Patients in this group will receive Transversus Abdominis block guided by the laparoscope at the beginning of surgery.	Procedure: Bariatric surgery; Laparoscopic bariatric procedure will be performed; Device: Endotracheal intubation; An endotracheal tube will be inserted as a part of general anesthesia to all patients; Procedure: 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.; Drug: Propofol; The patients will receive propofol for induction of anesthesia
Active Comparator: Erector spinae block; Patients in this group will receive Erector Spinae block guided by the ultrasound after induction of anesthesia.	Procedure: Bariatric surgery; Laparoscopic bariatric procedure will be performed; Device: Endotracheal intubation; An endotracheal tube will be inserted as a part of general anesthesia to all patients; Drug: Propofol; The patients will receive propofol for induction of anesthesia; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical rating scale	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	24 hours after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Ahmed Hasanin, Professor, professor of anesthesia

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2024
• Primary Completion (Actual): January 5, 2025
• Study Completion (Actual): January 9, 2025

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Propofol
• Other Study ID Numbers: MD-292-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No