Duloxetine Role in Reducing Opioid Consumption After Thoracotomy

Assiut University

Status and phase

Completed

Phase 4

Conditions

Post-thoracotomy Pain

Treatments

Drug: Oral Duloxetine 60mg

Drug: placebo pill

Study type

Interventional

Funder types

Other

Identifiers

NCT03618225

IORG0006563

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.