Comparison of the Efficacy of One Level and Tow Level of Bilateral Thoracic Erector Spinae Plane Block Combined With General Anesthesia in Laparoscopic Bariatric Surgery for Obese Patients: Randomized Controlled Trial
Launched by KASR EL AINI HOSPITAL · Feb 5, 2025
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at two different methods of providing pain relief during and after surgery for obese patients undergoing laparoscopic bariatric surgery, which includes procedures like sleeve gastrectomy and Roux-en-Y gastric bypass. Specifically, it compares a single injection (one-level) versus two injections (two-level) of a type of nerve block called the thoracic erector spinae plane block. The goal is to see which method works better in managing pain during and after the surgery.
To be eligible for this study, patients should be between 18 and 60 years old, have a body mass index (BMI) of 35 or higher, and be classified as having a moderate health status by the American Society of Anesthesiologists. Patients who refuse the nerve block or have certain medical conditions, like neurological disorders or bleeding problems, cannot participate. Those who join can expect to receive either the one-level or two-level nerve block before their surgery and will be monitored for pain relief effectiveness during their recovery. This trial is currently recruiting participants and is important for improving pain management techniques in bariatric surgery.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • • Patient age ranges 18 to 60 years old
- • Obese patients ; Body mass index(BMI) ≥ 35 - 50 kg/m2
- • American Society of Anesthesiologists (ASA) physical status classes II to III
- • Patients scheduled for laparoscopic bariatric surgery i.e. sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB) surgeries
- Exclusion Criteria:
- • • Refusal of regional block
- • Patients with neurological, psychological disorders or those lacking cooperation
- • Patients scheduled for concomitant laparoscopic cholecystectomy or paraumbilical hernia repair or those with history of previous bariatric surgery or obstructive sleep apnea
- • Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion.
- • Patients with bleeding disorders defined as (INR \>1.4) and/ or (platelet count \<100,000/µL)
- • Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement.
- • Patients who are allergic to amide local anesthetics.
About Kasr El Aini Hospital
Kasr El Aini Hospital, a prestigious medical institution affiliated with Cairo University, is dedicated to advancing healthcare through innovative clinical research. With a commitment to excellence, the hospital serves as a leading sponsor of clinical trials, leveraging its state-of-the-art facilities and a multidisciplinary team of healthcare professionals. The institution focuses on a diverse range of therapeutic areas, aiming to improve patient outcomes and contribute to the global medical community. By fostering collaboration and adhering to the highest ethical standards, Kasr El Aini Hospital plays a pivotal role in the development of new treatments and therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cairo, , Egypt
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported