Managing postoperative pain after laparoscopic gallbladder surgery
Postoperative Pain Management Following Laparoscopic Cholecystectomy- Vortioxetine
This study is testing if giving Vortioxetine before laparoscopic gallbladder surgery can help manage pain better in the first two days after the operation.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Future University in Egypt Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06561438 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and tolerability of Vortioxetine, a serotonergic antidepressant, as an adjuvant treatment for managing postoperative pain in patients undergoing laparoscopic cholecystectomy. The focus is on administering Vortioxetine preoperatively to improve pain control during the critical first 48 hours after surgery, which is crucial for preventing the development of chronic pain. The trial aims to determine if this approach can enhance recovery and reduce hospital stay duration for patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 scheduled for elective laparoscopic cholecystectomy.
Not a fit: Patients with chronic pain conditions unrelated to cholelithiasis or those with severe hepatic or renal dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing laparoscopic cholecystectomy, potentially reducing the risk of chronic pain.
How similar studies have performed: While the use of Vortioxetine for postoperative pain management is novel, similar studies have shown promise in utilizing multimodal analgesia for pain control.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who are scheduled to undergo elective LC. * Adults (males and/or females) between the ages of 18-70 years old. Exclusion Criteria: * Chronic pain other than cholelithiasis. * Patients who received analgesics or sedatives 24 h before scheduled surgery. * Severe hepatic (Child Pugh Class B and C) and renal dysfunction (CrCl \<30ml/min) * Previous allergic response to vortioxetine. * Pregnancy and lactation * Patients with communication problems, cognitive dysfunction, or psychological disorders * Daily corticosteroid use
Where this trial is running
Cairo
- National Hepatology and Tropical Research Institute — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Hoda Mohamed Bayoumi, Bachelor's
- Email: hoda.bayoumy@fue.edu.eg
- Phone: 01126143971
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.