Duloxetine Role in Reducing Opioid Consumption After Thoracotomy

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03618225
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.5
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

A total of 60 patients scheduled for thoracotomy with the aim of excision of pleural or lung cancer, will be randomized by the use of a computer-generated table of random numbers to receive duloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure or a placebo pill following the same time schedule.

Condition or Disease	Intervention/Treatment	Phase
Post-thoracotomy Pain	Drug: Oral Duloxetine 60mg; Drug: placebo pill	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Duloxetine Role in Reducing Opioid Consumption After Thoracotomy
• Actual Study Start Date: Aug 15, 2018
• Actual Primary Completion Date: Jan 31, 2020
• Actual Study Completion Date: Jan 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: duloxetine group duloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure.	Drug: Oral Duloxetine 60mg; duloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure
Placebo Comparator: placebo pill group placebo pill orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure.	Drug: placebo pill; placebo pill orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure

Outcome Measures

Primary Outcome Measures

1. Total dose of morphine needed to treat postoperative pain [48 hours]

   Total dose of morphine needed to treat postoperative pain over 48 hours of study period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria

• ASA I, II, and III patients scheduled for thoracotomy for pleural or lung cancer resection.

• Age above 18 years & less than 65 years.

• Adequate coagulation function within 30 days of surgery, defined as platelet count 100,000/mL or more, INR≤ 1.5, and partial thromboplastin time ≤40 seconds.

Exclusion criteria:

• Allergy to duloxetine or to local anesthetics.

• Patients with educational, psychiatric (untreated or poorly controlled schizophrenia, major depression, or bipolar disorder), or communication (language) barriers that would prevent understanding of the informed consent & preclude accurate assessment of postoperative pain and/or ability to answer questions about pain.

• Patients with severe renal and/or liver disease.

• History of chronic pain, long term narcotic use and/or antidepressants.

• Reasons for exclusion after randomization will be protocol violations or patient request.

• Fever, evidence of infection, or other coexisting medical conditions that would preclude epidural placement.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Institute, Cairo University	Cairo		Egypt

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed H Othman, Assisstant professor of Anesthesia ICU and pain Relief, Assiut University
• ClinicalTrials.gov Identifier: NCT03618225
• Other Study ID Numbers: IORG0006563
• First Posted: Aug 7, 2018
• Last Update Posted: Oct 14, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Duloxetine Hydrochloride

Study Results

No Results Posted as of Oct 14, 2021