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Completed

NCT Number: NCT06564610

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

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.

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Key information

Conditions

Pain, Postoperative Agnosia Analgesia Body Weight Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Cairo University.

Cairo, Cairo Governorate, 11432, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transversus abdominis block

Procedure

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

erector spinae block

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

Procedure

Laparoscopic bariatric procedure will be performed

Endotracheal intubation

Device

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

Propofol

Drug

The patients will receive propofol for induction of anesthesia

Primary outcomes

  1. 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

  1. Consumption of analgesia

    Time frame: 24 hours after surgery

    This is the total consumption of nalbuphine by the patient measured in milligrams

  2. Heart rate

    Time frame: 24 hours after surgery

    This is the number of heart beats measured as frequency of heart beats in one minute.

  3. Systolic blood pressure

    Time frame: 24 hours after surgery

    This is the systolic arterial blood pressure measured in mmHg.

  4. Vomiting

    Time frame: 24 hours

    This is the incidence of vomiting after surgery measured as the frequency of patients with vomiting.

  5. Diastolic blood pressure

    Time frame: 24 hours

    This is the diastolic arterial blood pressure measured in mmHg.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2024
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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