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Corticosteroid
Dexamethasone for Chronic Pain After Thoracic Surgery
N/A
Recruiting
Led By Veronique Brulotte, MD, Msc
Research Sponsored by Maisonneuve-Rosemont Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-75 years old
Elective thoracic surgery using a thoracotomy incision and thoracic epidural analgesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 h after surgery
Awards & highlights
Study Summary
This trial looks at whether dexamethasone can help reduce post-operative pain in those who have had thoracic surgery.
Who is the study for?
This trial is for adults aged 18-75 who are scheduled for elective thoracic surgery with a specific type of incision and pain relief method. It's not open to those already on cortisone or dexamethasone, anyone refusing participation, patients with conditions that don't allow the planned pain relief approach, or those on long-term opioid treatment.Check my eligibility
What is being tested?
The study tests if Dexamethasone given before surgery can reduce chronic post-surgery pain by tackling inflammation. Patients will either receive this drug or a saline solution as a comparison. The main goal is to see if there's less pain three months after thoracic surgery.See study design
What are the potential side effects?
Dexamethasone may cause side effects like increased blood sugar levels, mood changes, higher risk of infection due to immune suppression, stomach ulcers, insomnia and possibly others related to its anti-inflammatory action.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Select...
I am scheduled for chest surgery with a specific type of cut and pain management.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 h after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 h after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Brief pain inventory questionnaire
Leeds Assessment of Neuropathic Signs and Symptoms questionnaire
cytokine elevation
+2 moreSide effects data
From 2013 Phase 4 trial • 122 Patients • NCT014749152%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: dexamethasone 10 mgExperimental Treatment1 Intervention
Dexamethasone 10 mg will be given as a single-dose, pre incision, intravenously
Group II: normal salinePlacebo Group1 Intervention
Patients in this group will receive 2.5 mL of normal saline intravenously, pre-incision
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Find a Location
Who is running the clinical trial?
Maisonneuve-Rosemont HospitalLead Sponsor
99 Previous Clinical Trials
36,263 Total Patients Enrolled
Veronique Brulotte, MD, MscPrincipal InvestigatorMaisonneuve-Rosemont Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have an epidural in my upper back due to health reasons.I am currently taking cortisone or dexamethasone.You are taking strong pain medications regularly.I am between 18 and 75 years old.I am scheduled for chest surgery with a specific type of cut and pain management.You are classified as having a low to moderate risk for surgery, based on your overall health and medical history.I have chosen not to participate in the trial.
Research Study Groups:
This trial has the following groups:- Group 1: normal saline
- Group 2: dexamethasone 10 mg
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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