Duloxetine for Postoperative Pain of Laparoscopic Cholecystectomy

Phase 2

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Placebo; Drug: Duloxetine

• Registration Number: NCT05115123
• Lead Sponsor: Mansoura University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-10
• Study Start: 2022-03-02
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-13
• Last Update Posted: 2022-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	patients scheduled for elective LC will receive placebo before surgery
Intervention	Duloxetine	patients scheduled for elective LC will receive 60 mg duloxetine before surgery

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Egypt