Blocking nerves during gallbladder surgery to reduce pain and nausea
Intraoperative Autonomic Blockade to Prevent Early Postoperative Pain After Laparoscopic Cholecystectomy: A Double-Blind, Randomized Controlled Trial
This study is testing if using a combination of a long-lasting pain medicine and a steroid during gallbladder surgery can help reduce pain and nausea for patients after the operation.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad Simón Bolívar Academic / other |
| Locations | 2 sites (Barranquilla, Atlantivo and 1 other locations) |
| Trial ID | NCT06753500 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of a combination of Bupivacaine, a long-acting local anesthetic, and Dexamethasone, a corticosteroid, to infiltrate specific areas during laparoscopic cholecystectomy. The goal is to block the hepatic branches of the celiac plexus, which may improve visceral pain control and reduce the need for analgesics post-surgery. By enhancing pain management, the study aims to lower readmission rates and facilitate quicker recovery for patients. This approach has not been previously tested in the context of laparoscopic cholecystectomy.
Who should consider this trial
Good fit: Ideal candidates include individuals scheduled for elective or emergency laparoscopic cholecystectomy due to cholelithiasis, with or without cholecystitis.
Not a fit: Patients with associated biliary pathologies or those requiring additional surgical procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could significantly improve postoperative pain management and recovery for patients undergoing gallbladder surgery.
How similar studies have performed: While this specific approach has not been tested, similar techniques in pain management have shown promise in other surgical contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Elective or emergency laparoscopic cholecystectomy for cholelithiasis with or without cholecystitis. Exclusion Criteria: * Associated biliary pathologies (e.g., biliary pancreatitis, cholangitis). * Additional procedures, such as formal bile duct exploration. Conversion to an open approach * Anesthesia or Surgical complications that require intensive care unit * Allergies to local anesthetics
Where this trial is running
Barranquilla, Atlantivo and 1 other locations
- Clinica Portoazul — Barranquilla, Atlantivo, Colombia (Recruiting)
- clinica Iberoamerica — Barranquilla, Atlántico, Colombia (Recruiting)
Study contacts
- Study coordinator: Jorge Daes, MD
- Email: jorgedaez@gmail.com
- Phone: +573106363636
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.