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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02112864
Other study ID # dexaPTPS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 2014
Est. completion date July 2025

Study information

Verified date March 2023
Source Maisonneuve-Rosemont Hospital
Contact Véronique Brulotte, MD, MSc
Phone 514 252-3400
Email veronique.brulotte@umontreal.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date July 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - elective thoracic surgery using a thoracotomy incision and thoracic epidural analgesia - ASA I-III - age 18-75 yo Exclusion Criteria: - contra-indication to thoracic epidural analgesia - patient refusal - patients already taking cortisone or dexamethasone - patients on chronic opioid medication

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexamethasone
10 mg (2.5 ml)
Normal Saline
2.5 mL normal saline

Locations

Country Name City State
Canada Maisonneuve-Rosemont Hospital Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary cytokine elevation 24 h after surgery
Secondary incidence of post thoracotomy pain syndrome 3 months after surgery
Secondary incidence of post thoracotomy pain syndrome 6 months after surgery
Secondary incisional and shoulder pain acute post operative period
Secondary Brief pain inventory questionnaire three months after surgery
Secondary Brief pain inventory questionnaire 6 months after surgery
Secondary Leeds Assessment of Neuropathic Signs and Symptoms questionnaire three and six months after surgery
Secondary cytokine elevation 1h after surgery
Secondary cytokine elevation 48 h after surgery
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