Postoperative Pain
Conditions
Keywords
laparoscopic, 5-HT3 and 5-HT7 receptors inhibition, post-operative pain
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
Interventions
20 mg oral vortioxetine tablet 2 hours before the procedure
Sponsors
Future University in Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed