Duloxetine for Postoperative Pain of Laparoscopic Cholecystectomy

Mansoura University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain, Postoperative

Interventions

DuloxetineDRUG

60 mg duloxetine

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Mansoura University

Al Mansurah, Egypt

Outcomes

Primary Outcomes

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)

Time frame: 24 Hours postoperative

Secondary Outcomes

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.

Time frame: 24 Hours postoperative

Data from ClinicalTrials.gov

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