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OpenTrials
Completed

NCT Number: NCT03618225

Duloxetine Role in Reducing Opioid Consumption After Thoracotomy

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Cancer Institute, Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral Duloxetine 60mg

Drug

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

Placebo pill

Drug

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

Primary outcomes

  1. Total dose of morphine needed to treat postoperative pain

    Time frame: 48 hours

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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 7, 2018
Registry last updated
Oct 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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