Venlafaxine for Postoperative Pain of Laparoscopic Cholecystectomy

Sponsor

Mansoura University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05884268

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Recent studies on the impact of perioperative venlafaxine for treatment of acute postoperative pain have yielded positive outcomes . The aim of the present study is to investigate the role of perioperative venlafaxine on the management of postoperative pain in patients undergoing LC.

Condition or Disease	Intervention/Treatment	Phase
Laparoscopic Cholecystectomy	Drug: Venlafaxine Drug: Placebo	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Evaluating Safety and Tolerability of Venlafaxine for Postoperative Pain of Laparoscopic Cholecystectomy

Anticipated Study Start Date :

May 30, 2023

Anticipated Primary Completion Date :

Jan 30, 2024

Anticipated Study Completion Date :

Jan 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Laparoscopic Cholecystectomy	Drug: Venlafaxine Patients scheduled for elective LC will receive 150 mg venlafaxine before surgery
Placebo Comparator: Control	Drug: Placebo Patients scheduled for elective LC will receive placebo venlafaxine before surgery

Arm

Intervention/Treatment

Active Comparator: Laparoscopic Cholecystectomy

Drug: Venlafaxine

Patients scheduled for elective LC will receive 150 mg venlafaxine before surgery

Placebo Comparator: Control

Drug: Placebo

Patients scheduled for elective LC will receive placebo venlafaxine before surgery

Outcome Measures

Primary Outcome Measures

Change in postoperative pain between the two groups using visual analogue score (VAS) [24 Hours postoperative]
pain will be assessed using visual analogue score (VAS) 0-100 mm (0 indicated no pain, 100 denoted the most severe pain) pain will be assessed using visual analogue score (VAS) 0-100 mm (0 indicated no pain, 100 denoted the most severe pain)

Secondary Outcome Measures

Postoperative nausea and vomiting (PONV) [24 Hours postoperative]
will be assessed using PONV scale a 4-point scale: none (0): no nausea, vomiting, and retching; mild (1): happened once; moderate (2): happened 2-3 times; and severe (3): continuous or more than three times.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. Patients who are scheduled to undergo elective LC

Exclusion Criteria:

1- Patients with acute pancreatitis 2. Patients undergoing chronic pain treatment 3. Patients who received analgesics or sedatives 24 h before scheduled surgery 3. Patients had alcohol or drug addiction 4. Severe hepatic and renal dysfunction 5. Previous allergic response to duloxetine 6. Pregnancy and lactation 7. Patients with communication problems, cognitive dysfunction, or psychological disorders

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Noha Mansour, Principal investigator-Lecturer of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department, Mansoura University

ClinicalTrials.gov Identifier:

NCT05884268

Other Study ID Numbers:

6-2023

First Posted:

Jun 1, 2023

Last Update Posted:

Jun 1, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Venlafaxine Hydrochloride

Study Results

No Results Posted as of Jun 1, 2023