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Completed

NCT Number: NCT05115123

Duloxetine for Postoperative Pain of Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mansoura University

Al Mansurah, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duloxetine

Drug

60 mg duloxetine

Placebo

Drug

Placebo

Primary outcomes

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

    Time frame: 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 outcomes

  1. Postoperative nausea and vomiting (PONV)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Collaborators

  • National Hepatology & Tropical Medicine Research Institute

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 10, 2021
Registry last updated
May 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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