Postoperative Pain Management Following Laparoscopic Cholecystectomy

NCT06561438 | Completed Phase 3

• 1 other identifier: 02/2024
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain

Keywords

laparoscopic; 5-HT3 and 5-HT7 receptors inhibition; post-operative pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time to analgesic request

  24 hours

• Quality of life (QoL) after laparoscopic cholecystectomy (LC)

  3 months

Study Arms (2)

Control Arm

NO INTERVENTION

The patient will not be administered with any drug/placebo before the surgery

Intervention arm

EXPERIMENTAL

20 mg oral vortioxetine tablet 2 hours before the procedure

Drug: Vortioxetine 20Mg Tab

Interventions

Vortioxetine 20Mg Tab DRUG

20 mg oral vortioxetine tablet 2 hours before the procedure

Intervention arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are scheduled to undergo elective LC.
• Adults (males and/or females) between the ages of 18-70 years old.

You may not qualify if:

• 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

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

National Hepatology and Tropical Research Institute

Cairo, 11617, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 17, 2024
• First Posted: August 20, 2024
• Study Start: August 6, 2024
• Primary Completion: June 7, 2025
• Study Completion: June 7, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)