Postoperative Pain Management Following Laparoscopic Cholecystectomy

Phase 3

Recruiting

• Conditions: Postoperative Pain
• Interventions: Drug: Vortioxetine 20Mg Tab

• Registration Number: NCT06561438
• Lead Sponsor: Future University in Egypt

Brief Summary

Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. No. study has investigated Vortioxetine as an adjuvant to standard care for postoperative pain management in patients undergoing LC

Detailed Description

Postoperative pain is a main challenge for delayed hospital discharge in Laparoscopic cholecystectomy. . Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. Vortioxetine (VO) is a multimodal serotonergic antidepressant with a unique mechanism of action that is effective in treating neuropathic pain. The purpose of this study is evaluating the efficacy and tolerability of preoperative oral administration of Vortioxetine on postoperative pain control in patients undergoing LC

Study Timeline

• Study First Submitted: 2024-08-17
• Study First Submitted QC: 2024-08-17
• Study First Posted: 2024-08-20
• Study Start: 2024-08-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Vortioxetine 20Mg Tab	20 mg oral vortioxetine tablet 2 hours before the procedure

Primary Outcome Measures

Name	Time	Method
VAS score (Visual analogue scale)	2 hours, 4 hours, 8 hours, 12 hours, 24 hours	Pain intensity: VAS score from 0 to 100 mm In which 0 means no pain, and 100 means the worst pain possible

Secondary Outcome Measures

Name	Time	Method
Time to analgesic request	24 hours	Time to analgesic request
Quality of life (QoL) after laparoscopic cholecystectomy (LC)	3 months	Gastrointestinal Quality of Life Index questionnaire for QOL assessment with calculation of the score; most desirable option: 4 points, least desirable option: 0 points and GIQLI score: sum of the point. GIQLI ranges from 0 to 80 with higher scores indicating a better quality of life.

Trial Locations

Locations (1)

National Hepatology and Tropical Research Institute; 🇪🇬 Cairo, Egypt