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Completed

NCT Number: NCT06561438

Postoperative Pain Management Following 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. No. study has investigated Vortioxetine as an adjuvant to standard care for postoperative pain management in patients undergoing LC

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Hepatology and Tropical Research Institute

Cairo, 11617, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vortioxetine 20Mg Tab

Drug

20 mg oral vortioxetine tablet 2 hours before the procedure

Primary outcomes

  1. 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

  1. Time to analgesic request

    Time frame: 24 hours

    Time to analgesic request

  2. Quality of life (QoL) after laparoscopic cholecystectomy (LC)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

Postoperative Pain Management Following Laparoscopic Cholecystectomy- Vortioxetine

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2024
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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