Duloxetine for Postoperative Pain of Laparoscopic Cholecystectomy
Duloxetine Efficacy and Tolerability for Pain Management in Patients Undergoing Laparoscopic Cholecystectomy
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2022
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2021
CompletedFirst Posted
Study publicly available on registry
November 10, 2021
CompletedStudy Start
First participant enrolled
March 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedMay 16, 2022
May 1, 2022
2 months
November 1, 2021
May 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Postoperative nausea and vomiting (PONV)
24 Hours postoperative
Study Arms (2)
Intervention
ACTIVE COMPARATORpatients scheduled for elective LC will receive 60 mg duloxetine before surgery
Control
PLACEBO COMPARATORpatients scheduled for elective LC will receive placebo before surgery
Interventions
Eligibility Criteria
You may qualify if:
- \. Patients who are scheduled to undergo elective LC
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura University
Al Mansurah, 35516, Egypt
Related Publications (1)
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.
PMID: 36249765DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
November 1, 2021
First Posted
November 10, 2021
Study Start
March 2, 2022
Primary Completion
April 30, 2022
Study Completion
April 30, 2022
Last Updated
May 16, 2022
Record last verified: 2022-05