Duloxetine Role in Reducing Opioid Consumption After Thoracotomy

Post-thoracotomy Pain Clinical Trial

Official title:

Duloxetine Role in Reducing Opioid Consumption After Thoracotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03618225
• Other study ID #: IORG0006563
• Status: Completed
• Phase: Phase 4
• Start date: August 15, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: October 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Post-thoracotomy Pain

Intervention

Drug:
• Oral Duloxetine 60mg
duloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure
• placebo pill
placebo pill orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure

Locations

Country	Name	City	State
Egypt	National Cancer Institute, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total dose of morphine needed to treat postoperative pain	Total dose of morphine needed to treat postoperative pain over 48 hours of study period	48 hours