Comparing one-level and two-level thoracic nerve blocks for pain management in obese patients undergoing bariatric surgery
Comparison of the Efficacy of One Level and Two Level of Bilateral Thoracic Erector Spinae Plane Block Combined With General Anesthesia in Laparoscopic Bariatric Surgery for Obese Patients: Randomized Controlled Trial.
This study is testing whether a single or double nerve block can help manage pain better for obese patients having weight loss surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Kasr El Aini Hospital Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06811493 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the efficacy and feasibility of one-level versus two-level thoracic erector spinae plane blocks in providing analgesia during and after laparoscopic bariatric surgery for obese patients. A total of 70 patients will be randomly assigned to receive either a one-level or two-level block prior to surgery. The study will assess the impact of these interventions on intraoperative and postoperative pain management. Comprehensive preoperative assessments will be conducted, including medical history, laboratory tests, and vital signs monitoring.
Who should consider this trial
Good fit: Ideal candidates for this study are obese patients aged 18 to 60 with a BMI between 35 and 50, scheduled for laparoscopic bariatric surgery.
Not a fit: Patients with neurological or psychological disorders, those who refuse regional blocks, or those with certain medical conditions such as bleeding disorders or hepatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance pain management strategies for obese patients undergoing bariatric surgery, potentially leading to improved recovery outcomes.
How similar studies have performed: Other studies have shown promising results with similar approaches in pain management, suggesting that this method may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Emad M. Abdelhafez, Lecturer
- Email: emadabady73@gmail.com
- Phone: 00201096324748
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.