CClinicalTrials.gg
RecruitingNCT02112864Updated Mar 20, 2023

Dexamethasone for Reduction of Post Thoracotomy Pain Syndrome

An interventional study of Dexamethasone and Normal Saline in Chronic Pain, Dexamethasone and Thoracic Surgery, sponsored by Maisonneuve-Rosemont Hospital. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-20.

Sponsored by Maisonneuve-Rosemont Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Chronic Pain
  • Dexamethasone
  • Thoracic Surgery
  • Cytokines

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03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Maisonneuve-Rosemont Hospital is the lead sponsor of 70 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

Exclusion Criteria:

  • contra-indication to thoracic epidural analgesia
  • patient refusal
  • patients already taking cortisone or dexamethasone
  • patients on chronic opioid medication
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    dexamethasone 10 mg

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

    Drug: Dexamethasone

  • Placebo comparator
    normal saline

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

    Drug: Normal Saline

Interventions

  • DrugDexamethasone

    10 mg (2.5 ml)

    Also known as: decadron

  • DrugNormal Saline

    2.5 mL normal saline

    Also known as: Placebo

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What researchers measure

Primary outcomes

  1. cytokine elevation

    Time frame: 24 h after surgery

Secondary outcomes

  1. incidence of post thoracotomy pain syndrome

    Time frame: 3 months after surgery

  2. incidence of post thoracotomy pain syndrome

    Time frame: 6 months after surgery

  3. incisional and shoulder pain

    Time frame: acute post operative period

  4. Brief pain inventory questionnaire

    Time frame: three months after surgery

  5. Brief pain inventory questionnaire

    Time frame: 6 months after surgery

  6. Leeds Assessment of Neuropathic Signs and Symptoms questionnaire

    Time frame: three and six months after surgery

  7. cytokine elevation

    Time frame: 1h after surgery

  8. cytokine elevation

    Time frame: 48 h after surgery

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Study locations

1 of 1 sites recruiting
  • Maisonneuve-Rosemont Hospital
    Montreal, Quebec H1T 4M5, Canada
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02112864
Lead sponsor
Maisonneuve-Rosemont Hospital
Responsible party
Veronique Brulotte (M.D., M.Sc., Maisonneuve-Rosemont Hospital) — Principal investigator
First posted
Apr 14, 2014
Start date
May 2014
Primary completion
Dec 2024 (estimated)
Completion
Jul 2025 (estimated)
Last update
Mar 20, 2023

Study contacts

Véronique Brulotte, MD, MSc
Contact
veronique.brulotte@umontreal.ca
514 252-3400 ext. 4558
Nadia Godin, nurse
Contact
ngodin.hmr.@ssss.gouv.qc.ca
514 252-3400 ext. 3193
Veronique Brulotte, MD, Msc
principal investigator · Maisonneuve-Rosemont Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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