Dexamethasone for Reduction of Post Thoracotomy Pain Syndrome
Impact of Dexamethasone on the Post Operative Inflammatory Response and on the Occurrence of Post Thoracotomy Pain Syndrome
1 other identifier
interventional
60
1 country
1
Brief Summary
Post thoracotomy pain syndrome still affects 50% of patients after a thoracic surgery. Pathogenesis is unclear but there is growing evidence that neuro inflammation may play a significant role. Dexamethasone is a very potent anti-inflammatory drug. The hypothesis of this study is that dexamethasone, given pre operatively, would help reduce the incidence of post thoracotomy pain syndrome 3 months after surgery, by reducing the inflammatory response, in patients undergoing elective thoracic surgery that includes thoracic epidural analgesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable chronic-pain
Started May 2014
Longer than P75 for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2014
CompletedFirst Posted
Study publicly available on registry
April 14, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedMarch 20, 2023
March 1, 2023
10.6 years
April 9, 2014
March 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
cytokine elevation
24 h after surgery
Secondary Outcomes (8)
incidence of post thoracotomy pain syndrome
3 months after surgery
incidence of post thoracotomy pain syndrome
6 months after surgery
incisional and shoulder pain
acute post operative period
Brief pain inventory questionnaire
three months after surgery
Brief pain inventory questionnaire
6 months after surgery
- +3 more secondary outcomes
Study Arms (2)
dexamethasone 10 mg
EXPERIMENTALDexamethasone 10 mg will be given as a single-dose, pre incision, intravenously
normal saline
PLACEBO COMPARATORPatients in this group will receive 2.5 mL of normal saline intravenously, pre-incision
Interventions
Eligibility Criteria
You may qualify if:
- elective thoracic surgery using a thoracotomy incision and thoracic epidural analgesia
- ASA I-III
- age 18-75 yo
You may not qualify if:
- contra-indication to thoracic epidural analgesia
- patient refusal
- patients already taking cortisone or dexamethasone
- patients on chronic opioid medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 4M5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Veronique Brulotte, MD, Msc
Maisonneuve-Rosemont Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., M.Sc.
Study Record Dates
First Submitted
April 9, 2014
First Posted
April 14, 2014
Study Start
May 1, 2014
Primary Completion
December 1, 2024
Study Completion
July 1, 2025
Last Updated
March 20, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share