Recruiting

Dexamethasone

Sponsor:

Maisonneuve-Rosemont Hospital

Code:

NCT02112864

Conditions

Chronic Pain

Dexamethasone

Thoracic Surgery

Cytokines

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dexamethasone

Normal Saline

Study Details

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.

Conditions

Chronic Pain

Dexamethasone

Thoracic Surgery

Cytokines

Study ID

NCT02112864

Start date

May, 2014

Status verified date

Mar, 2023

Completion date

Jul, 2025

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: dexamethasone 10 mg

Dexamethasone 10 mg will be given as a single-dose, pre incision, intravenously

placebo comparator: normal saline

Patients in this group will receive 2.5 mL of normal saline intravenously, pre-incision

Interventions

Dexamethasone

10 mg (2.5 ml)

Normal Saline

2.5 mL normal saline

Primary outcome measure

  • cytokine elevation [ Time Frame: 24 h after surgery ]

Central Contacts and Locations

Central contacts

Locations

Maisonneuve-Rosemont Hospital

Recruiting

Montreal, Quebec, Canada, H1T 4M5

Contacts

Principal Investigator:

Veronique Brulotte, MD, MSc

More Information

Sponsor

Maisonneuve-Rosemont Hospital

Last update posted

Mar 20, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maisonneuve-Rosemont Hospital on 2023-03-20.