Dexamethasone for Reduction of Post Thoracotomy Pain Syndrome

March 17, 2023 updated by: Veronique Brulotte, Maisonneuve-Rosemont Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 4M5
        • Recruiting
        • Maisonneuve-Rosemont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dexamethasone 10 mg
Dexamethasone 10 mg will be given as a single-dose, pre incision, intravenously
Drug: Dexamethasone
10 mg (2.5 ml)
Other Names:
  • decadron
Placebo Comparator: normal saline
Patients in this group will receive 2.5 mL of normal saline intravenously, pre-incision
Drug: Normal Saline
2.5 mL normal saline
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cytokine elevation
Time Frame: 24 h after surgery
24 h after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of post thoracotomy pain syndrome
Time Frame: 3 months after surgery
3 months after surgery
incidence of post thoracotomy pain syndrome
Time Frame: 6 months after surgery
6 months after surgery
incisional and shoulder pain
Time Frame: acute post operative period
acute post operative period
Brief pain inventory questionnaire
Time Frame: three months after surgery
three months after surgery
Brief pain inventory questionnaire
Time Frame: 6 months after surgery
6 months after surgery
Leeds Assessment of Neuropathic Signs and Symptoms questionnaire
Time Frame: three and six months after surgery
three and six months after surgery
cytokine elevation
Time Frame: 1h after surgery
1h after surgery
cytokine elevation
Time Frame: 48 h after surgery
48 h after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maisonneuve-Rosemont Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (Estimate)

April 14, 2014

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dexaPTPS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Pain

Clinical Trials on Dexamethasone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe