MedDataX Logo

Duloxetine Role in Reducing Opioid Consumption After Thoracotomy

NCT ID: NCT03618225

Last Updated: 2021-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-15

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-thoracotomy Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

duloxetine group

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

Group Type ACTIVE_COMPARATOR

Oral Duloxetine 60mg

Intervention Type DRUG

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

placebo pill group

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

Group Type PLACEBO_COMPARATOR

placebo pill

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral Duloxetine 60mg

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

Intervention Type DRUG

placebo pill

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed H Othman

Assisstant professor of Anesthesia ICU and pain Relief

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Cancer Institute, Cairo University

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IORG0006563

Identifier Type: -

Identifier Source: org_study_id