Duloxetine Role in Reducing Opioid Consumption After Thoracotomy
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 |
---|---|---|
|
Phase 4 |
Study Design
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
- 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
Inclusion criteria
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ASA I, II, and III patients scheduled for thoracotomy for pleural or lung cancer resection.
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Age above 18 years & less than 65 years.
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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:
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Allergy to duloxetine or to local anesthetics.
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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.
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Patients with severe renal and/or liver disease.
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History of chronic pain, long term narcotic use and/or antidepressants.
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Reasons for exclusion after randomization will be protocol violations or patient request.
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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.- IORG0006563