Clinical trial

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

Name

6-2023

Description

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.

Trial arms

Trial start

2023-05-30

Estimated PCD

2024-01-30

Trial end

2024-01-30

Status

Not yet recruiting

Phase

Early phase I

Treatment

Venlafaxine

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

Arms:

Laparoscopic Cholecystectomy

Placebo

Patients scheduled for elective LC will receive placebo venlafaxine before surgery

Arms:

Control

Size

Primary endpoint

Change in postoperative pain between the two groups using visual analogue score (VAS)

24 Hours postoperative

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2023-06-01

1 organization

1 product

1 drug

1 indication

Organization

Product

Indication

Drug