Dexamethasone for Reduction of Post Thoracotomy Pain Syndrome

Chronic Pain Clinical Trial

Official title:

Impact of Dexamethasone on the Post Operative Inflammatory Response and on the Occurrence of Post Thoracotomy Pain Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02112864
• Other study ID #: dexaPTPS
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Pain
• Cytokines
• Dexamethasone
• Thoracic Surgery

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