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.

Study Overview

• Status: Completed
• Conditions: Post-thoracotomy Pain
• Intervention / Treatment: Drug: Oral Duloxetine 60mg; Drug: placebo pill

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • National Cancer Institute, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: duloxetine group; duloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure.	Drug: Oral Duloxetine 60mg; duloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure
PLACEBO_COMPARATOR: placebo pill group; placebo pill orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure.	Drug: placebo pill; placebo pill orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 15, 2018
• Primary Completion (ACTUAL): January 31, 2020
• Study Completion (ACTUAL): January 31, 2020

Study Registration Dates

• First Submitted: July 14, 2018
• First Submitted That Met QC Criteria: August 4, 2018
• First Posted (ACTUAL): August 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: IORG0006563

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No