Dexamethasone for Reduction of Post Thoracotomy Pain Syndrome

Not Applicable

Recruiting

• Conditions: Chronic Pain; Dexamethasone; Thoracic Surgery; Cytokines
• Interventions: Drug: Normal Saline; Drug: Dexamethasone

• Registration Number: NCT02112864
• Lead Sponsor: Maisonneuve-Rosemont Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-04-09
• Study First Posted: 2014-04-14
• Study Start: 2014-05
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-17
• Last Update Posted: 2023-03-20
• Primary Completion: 2024-12
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline	Normal Saline	Patients in this group will receive 2.5 mL of normal saline intravenously, pre-incision
dexamethasone 10 mg	Dexamethasone	Dexamethasone 10 mg will be given as a single-dose, pre incision, intravenously

Primary Outcome Measures

Name	Time	Method
cytokine elevation	24 h after surgery

Secondary Outcome Measures

Name	Time	Method
incidence of post thoracotomy pain syndrome	6 months after surgery
incisional and shoulder pain	acute post operative period
Brief pain inventory questionnaire	6 months after surgery
Leeds Assessment of Neuropathic Signs and Symptoms questionnaire	three and six months after surgery
cytokine elevation	48 h after surgery

Trial Locations

Locations (1)

Maisonneuve-Rosemont Hospital; 🇨🇦 Montreal, Quebec, Canada