Using Erector Spinae Plane Block for Pain Relief in Super Obese Patients Undergoing Bariatric Surgery
The Efficacy of Thoracic Erector Spinae Plane Block For Perioperative Analgesia in Laparoscopic Bariatric Surgery for Super Obese Patients: Randomized Controlled Trial
This study is testing if a special pain relief technique called the erector spinae plane block can help super obese patients feel less pain after laparoscopic bariatric surgery compared to a regular local anesthetic.
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 | NCT06377605 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of the erector spinae plane block (ESPB) as a method for providing perioperative analgesia in super obese patients undergoing laparoscopic bariatric surgery. The study will randomly assign 60 eligible patients to receive either the ESPB or local anesthetic infiltration for pain management. Preoperative assessments will include medical history, laboratory tests, and vital signs monitoring. The goal is to evaluate the efficacy of ESPB in reducing postoperative pain and minimizing opioid use, which can lead to complications in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are super obese patients aged 18 to 60 with a BMI greater than 50 kg/m2 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 approach could significantly improve pain management and reduce opioid-related complications in super obese patients after bariatric surgery.
How similar studies have performed: Other studies have shown promising results with the use of erector spinae plane blocks for pain management, suggesting that this approach may be effective in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient age \>18 \<60 * Super Obese patients ; Body mass index(BMI) \> 50 kg/m2 * Both sexes * American Society of Anesthesiologists(ASA) physical status classes II and 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. * Cases converted to open surgery will also be excluded from the study
Where this trial is running
Cairo
- Kasr Al Ainy Hospitals — Cairo, Egypt (Recruiting)
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.