Duloxetine Role in Reducing Opioid Consumption After Thoracotomy

• Status: Completed
• Trial end date: 2020-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assiut University
• Treatments: Duloxetine Hydrochloride

Criteria

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.