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Dexamethasone for Reduction of Post Thoracotomy Pain Syndrome

Sponsor
Maisonneuve-Rosemont Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT02112864
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
98
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Impact of Dexamethasone on the Post Operative Inflammatory Response and on the Occurrence of Post Thoracotomy Pain Syndrome
Study Start Date :
May 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. cytokine elevation [24 h after surgery]

    Secondary Outcome Measures

    1. incidence of post thoracotomy pain syndrome [3 months after surgery]

    2. incidence of post thoracotomy pain syndrome [6 months after surgery]

    3. incisional and shoulder pain [acute post operative period]

    4. Brief pain inventory questionnaire [three months after surgery]

    5. Brief pain inventory questionnaire [6 months after surgery]

    6. Leeds Assessment of Neuropathic Signs and Symptoms questionnaire [three and six months after surgery]

    7. cytokine elevation [1h after surgery]

    8. cytokine elevation [48 h after surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maisonneuve-Rosemont Hospital Montreal Quebec Canada H1T 4M5

    Sponsors and Collaborators

    • Maisonneuve-Rosemont Hospital

    Investigators

    • Principal Investigator: Veronique Brulotte, MD, Msc, Maisonneuve-Rosemont Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Veronique Brulotte, M.D., M.Sc., Maisonneuve-Rosemont Hospital
    ClinicalTrials.gov Identifier:
    NCT02112864
    Other Study ID Numbers:
    • dexaPTPS
    First Posted:
    Apr 14, 2014
    Last Update Posted:
    Aug 13, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Chronic Pain
    Dexamethasone

    Study Results

    No Results Posted as of Aug 13, 2021