Duloxetine Role in Reducing Opioid Consumption After Thoracotomy

NCT03618225 | Completed Phase 4

• 1 other identifier: IORG0006563
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-thoracotomy Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

duloxetine group

ACTIVE COMPARATOR

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

Drug: Oral Duloxetine 60mg

placebo pill group

PLACEBO COMPARATOR

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

Drug: placebo pill

Interventions

Oral Duloxetine 60mg DRUG

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

duloxetine group

placebo pill DRUG

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

placebo pill group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Fever, evidence of infection, or other coexisting medical conditions that would preclude epidural placement.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

National Cancer Institute, Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Duloxetine Hydrochloride

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant professor of Anesthesia ICU and pain Relief

Study Record Dates

• First Submitted: July 14, 2018
• First Posted: August 7, 2018
• Study Start: August 15, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

EG (1)