Postoperative Pain Management Following Laparoscopic Cholecystectomy

Postoperative Pain Management Following Laparoscopic Cholecystectomy- Vortioxetine

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Vortioxetine 20Mg Tab

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 Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11617
    • National Hepatology and Tropical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; The patient will not be administered with any drug/placebo before the surgery
Experimental: Intervention arm; 20 mg oral vortioxetine tablet 2 hours before the procedure	Drug: Vortioxetine 20Mg Tab; 20 mg oral vortioxetine tablet 2 hours before the procedure

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (QoL) after laparoscopic cholecystectomy (LC)	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.	3 months
Time to analgesic request	Time to analgesic request	24 hours

Collaborators and Investigators

• Sponsor: Future University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2024
• Primary Completion (Actual): June 7, 2025
• Study Completion (Actual): June 7, 2025

Study Registration Dates

• First Submitted: August 17, 2024
• First Submitted That Met QC Criteria: August 17, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: laparoscopic; post-operative pain; 5-HT3 and 5-HT7 receptors inhibition
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Neurotransmitter Agents; Membrane Transport Modulators; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Antidepressive Agents; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists; Serotonin Agents; Selective Serotonin Reuptake Inhibitors; Serotonin Receptor Agonists; Serotonin 5-HT1 Receptor Agonists; Vortioxetine
• Other Study ID Numbers: 02/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No