Comparing lung atelectasis after bariatric surgery with and without a specific nerve block
The Incidence of Post-Operative Lung Atelectasis With Erector Spinae Plane Block in Bariatric Surgery: A Prospective Randomized Controlled Trial
This study tests if a specific nerve block during bariatric surgery can help prevent lung problems after the surgery compared to a placebo treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Kasr El Aini Hospital Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06695858 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the incidence of post-operative lung atelectasis in patients undergoing bariatric surgery by comparing two groups: one receiving an erector spinae plane block (ESPB) and the other receiving a sham block. Patients will be randomly assigned to either group, with the ESPB group receiving bupivacaine and the control group receiving normal saline. An experienced anesthetist will perform the procedures while a blinded investigator collects data on pain and other outcomes. The study will assess the effectiveness of ESPB in reducing the incidence of lung complications post-surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with a body mass index of 35 kg/m2 or higher who are scheduled for laparoscopic bariatric surgery.
Not a fit: Patients with ASA physical class greater than III, contraindications to regional anesthesia, or pre-existing chronic pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of post-operative lung atelectasis in bariatric surgery patients, leading to improved recovery outcomes.
How similar studies have performed: Other studies have shown promising results with similar nerve block techniques in reducing post-operative complications, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with body mass index ≥35 kg/m2 * scheduled to undergo laparoscopic bariatric surgery. Exclusion Criteria: * American Society of Anesthesiologists (ASA) physical class\> III. * Subjects with contraindications to peripheral regional anesthesia blocks * neurological or psychological disorders * inability to cooperate * pre-existing chronic pain or cognitive dysfunction
Where this trial is running
Cairo
- Cairo university hospitals — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: khaled sarhan, MD
- Email: khaled.sarhan@kasralainy.edu.eg
- Phone: +201020067816
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.