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NCT05884268 Clinical Trial

Venlafaxine for Postoperative Pain of Laparoscopic Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

Official title:
Evaluating Safety and Tolerability of Venlafaxine for Postoperative Pain of Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05884268
Other study ID # 6-2023
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date May 30, 2023
Est. completion date January 30, 2024

Study information
Verified date May 2023
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date January 30, 2024
Est. primary completion date January 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Venlafaxine
Patients scheduled for elective LC will receive 150 mg venlafaxine before surgery
• Placebo
Patients scheduled for elective LC will receive placebo venlafaxine before surgery

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Outcome
Type Measure Description Time frame Safety issue
Primary Change in postoperative pain between the two groups using visual analogue score (VAS) 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)		 24 Hours postoperative
Secondary Postoperative nausea and vomiting (PONV) 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. 24 Hours postoperative
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