Postoperative Pain Management Following Laparoscopic Cholecystectomy- Vortioxetine
Overview
- Phase
- Phase 3
- Intervention
- Vortioxetine 20Mg Tab
- Conditions
- Postoperative Pain
- Sponsor
- Future University in Egypt
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- VAS score (Visual analogue scale)
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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
Investigators
Hoda Mohamed
Principal investigator
Future University in Egypt
Eligibility 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
Arms & Interventions
Intervention arm
20 mg oral vortioxetine tablet 2 hours before the procedure
Intervention: Vortioxetine 20Mg Tab
Outcomes
Primary Outcomes
VAS score (Visual analogue scale)
Time Frame: 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 Outcomes
- Time to analgesic request(24 hours)
- Quality of life (QoL) after laparoscopic cholecystectomy (LC)(3 months)