Postoperative Pain Management Following Laparoscopic Cholecystectomy

NCT ID: NCT06561438

Last Updated: 2025-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-06

Study Completion Date

2025-06-07

Brief Summary

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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

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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

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention arm

20 mg oral vortioxetine tablet 2 hours before the procedure

Group Type EXPERIMENTAL

Vortioxetine 20Mg Tab

Intervention Type DRUG

20 mg oral vortioxetine tablet 2 hours before the procedure

Interventions

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Vortioxetine 20Mg Tab

20 mg oral vortioxetine tablet 2 hours before the procedure

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Future University in Egypt

OTHER

Sponsor Role lead

Responsible Party

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Hoda Mohamed

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Hepatology and Tropical Research Institute

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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02/2024

Identifier Type: -

Identifier Source: org_study_id

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