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Postoperative Pain Management Following Laparoscopic Cholecystectomy

F

Future University in Egypt

Status and phase

Completed
Phase 3

Conditions

Postoperative Pain

Treatments

Drug: Vortioxetine 20Mg Tab

Study type

Interventional

Funder types

Other

Identifiers

NCT06561438
02/2024

Details and patient eligibility

About

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

Full 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

Enrollment

86 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

86 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Hoda Mohamed Bayoumi, Bachelor's

Data sourced from clinicaltrials.gov

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