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Dexamethasone for Reduction of Post Thoracotomy Pain Syndrome

Primary Purpose

Chronic Pain, Dexamethasone, Thoracic Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dexamethasone
Normal Saline
Sponsored by
Maisonneuve-Rosemont Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maisonneuve-Rosemont HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

dexamethasone 10 mg

normal saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

cytokine elevation

Secondary Outcome Measures

incidence of post thoracotomy pain syndrome
incidence of post thoracotomy pain syndrome
incisional and shoulder pain
Brief pain inventory questionnaire
Brief pain inventory questionnaire
Leeds Assessment of Neuropathic Signs and Symptoms questionnaire
cytokine elevation
cytokine elevation

Full Information

First Posted
April 9, 2014
Last Updated
March 17, 2023
Sponsor
Maisonneuve-Rosemont Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02112864
Brief Title
Dexamethasone for Reduction of Post Thoracotomy Pain Syndrome
Official Title
Impact of Dexamethasone on the Post Operative Inflammatory Response and on the Occurrence of Post Thoracotomy Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maisonneuve-Rosemont Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Dexamethasone, Thoracic Surgery, Cytokines

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dexamethasone 10 mg
Arm Type
Experimental
Arm Description
Dexamethasone 10 mg will be given as a single-dose, pre incision, intravenously
Arm Title
normal saline
Arm Type
Placebo Comparator
Arm Description
Patients in this group will receive 2.5 mL of normal saline intravenously, pre-incision
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
decadron
Intervention Description
10 mg (2.5 ml)
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
Placebo
Intervention Description
2.5 mL normal saline
Primary Outcome Measure Information:
Title
cytokine elevation
Time Frame
24 h after surgery
Secondary Outcome Measure Information:
Title
incidence of post thoracotomy pain syndrome
Time Frame
3 months after surgery
Title
incidence of post thoracotomy pain syndrome
Time Frame
6 months after surgery
Title
incisional and shoulder pain
Time Frame
acute post operative period
Title
Brief pain inventory questionnaire
Time Frame
three months after surgery
Title
Brief pain inventory questionnaire
Time Frame
6 months after surgery
Title
Leeds Assessment of Neuropathic Signs and Symptoms questionnaire
Time Frame
three and six months after surgery
Title
cytokine elevation
Time Frame
1h after surgery
Title
cytokine elevation
Time Frame
48 h after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Véronique Brulotte, MD, MSc
Phone
514 252-3400
Ext
4558
Email
veronique.brulotte@umontreal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Nadia Godin, nurse
Phone
514 252-3400
Ext
3193
Email
ngodin.hmr.@ssss.gouv.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronique Brulotte, MD, Msc
Organizational Affiliation
Maisonneuve-Rosemont Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 4M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brulotte Veronique, MD, MSc
Phone
514 252-3400
Ext
4558
Email
veronique.brulotte@umontreal.ca
First Name & Middle Initial & Last Name & Degree
Veronique Brulotte, MD, MSc

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Dexamethasone for Reduction of Post Thoracotomy Pain Syndrome

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