Duloxetine Role in Reducing Opioid Consumption After Thoracotomy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03618225

Enrollment

Registered

2018-08-07

Start date

2018-08-15

Completion date

2020-01-31

Last updated

2021-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-thoracotomy Pain

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.

Interventions

DRUGOral Duloxetine 60mg

duloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure

DRUGplacebo pill

placebo pill orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026