Duloxetine for Postoperative Pain of Laparoscopic Cholecystectomy

Pain, Postoperative Clinical Trial

Official title:

Duloxetine Efficacy and Tolerability for Pain Management in Patients Undergoing Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05115123
• Other study ID #: 23-2021
• Status: Completed
• Phase: Phase 2
• Start date: March 2, 2022
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2022
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• 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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Duloxetine
60 mg duloxetine
• Placebo
Placebo

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura

Sponsors (2)

Lead Sponsor	Collaborator
Mansoura University	National Hepatology & Tropical Medicine Research Institute

Country where clinical trial is conducted

Egypt, 

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)	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