Duloxetine for Postoperative Pain of Laparoscopic Cholecystectomy
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Duloxetine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
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
Sites / Locations
- Mansoura University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
patients scheduled for elective LC will receive 60 mg duloxetine before surgery
patients scheduled for elective LC will receive placebo before surgery
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05115123
First Posted
November 1, 2021
Last Updated
May 13, 2022
Sponsor
Mansoura University
Collaborators
National Hepatology & Tropical Medicine Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05115123
Brief Title
Duloxetine for Postoperative Pain of Laparoscopic Cholecystectomy
Official Title
Duloxetine Efficacy and Tolerability for Pain Management in Patients Undergoing Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 2, 2022 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
Collaborators
National Hepatology & Tropical Medicine Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
patients scheduled for elective LC will receive 60 mg duloxetine before surgery
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
patients scheduled for elective LC will receive placebo before surgery
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Description
60 mg duloxetine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in postoperative pain between the two groups using visual analogue score (VAS)
Description
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 Outcome Measure Information:
Title
Postoperative nausea and vomiting (PONV)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mansoura University
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36249765
Citation
Mansour NO, Boraii S, Elnaem MH, Elrggal ME, Omar T, Abdelraouf A, Abdelaziz DH. Evaluation of preoperative duloxetine use for postoperative analgesia following laparoscopic cholecystectomy: A randomized controlled trial. Front Pharmacol. 2022 Sep 29;13:944392. doi: 10.3389/fphar.2022.944392. eCollection 2022.
Results Reference
derived
Learn more about this trial
Duloxetine for Postoperative Pain of Laparoscopic Cholecystectomy
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