Dexamethasone for Reduction of Post Thoracotomy Pain Syndrome

NCT ID: NCT02112864

Last Updated: 2023-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2025-07-31

Brief Summary

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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

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Conditions

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Chronic Pain Dexamethasone Thoracic Surgery Cytokines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dexamethasone 10 mg

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

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

10 mg (2.5 ml)

normal saline

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

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

2.5 mL normal saline

Interventions

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Dexamethasone

10 mg (2.5 ml)

Intervention Type DRUG

Normal Saline

2.5 mL normal saline

Intervention Type DRUG

Other Intervention Names

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decadron Placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role lead

Responsible Party

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Veronique Brulotte

M.D., M.Sc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Veronique Brulotte, MD, Msc

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve-Rosemont Hospital

Locations

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Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Véronique Brulotte, MD, MSc

Role: CONTACT

514 252-3400 ext. 4558

Nadia Godin, nurse

Role: CONTACT

514 252-3400 ext. 3193

Facility Contacts

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Brulotte Veronique, MD, MSc

Role: primary

514 252-3400 ext. 4558

Other Identifiers

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dexaPTPS

Identifier Type: -

Identifier Source: org_study_id

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