Chronic PainNCT02112864
Dexamethasone for Reduction of Post Thoracotomy Pain Syndrome
A study testing Dexamethasone and Normal Saline in people with Chronic Pain and Dexamethasone, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain, Dexamethasone, Thoracic Surgery
- What is being tested?
- Dexamethasone and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective thoracic surgery using a thoracotomy incision and thoracic epidural analgesia
- ASA I-III
- age 18-75 yo
Who cannot join
- contra-indication to thoracic epidural analgesia
- patient refusal
- patients already taking cortisone or dexamethasone
- patients on chronic opioid medication
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 4M5
Brulotte Veronique, MD, MSc, 514 252-3400 ext. 4558, veronique.brulotte@umontreal.ca
Veronique Brulotte, MD, MSc
About this study
Official title: 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.
- Conditions
- Chronic Pain, Dexamethasone, Thoracic Surgery, Cytokines
- Being tested
- Dexamethasone, Normal Saline
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called decadron
10 mg (2.5 ml)
Normal SalineDrug
Also called Placebo
2.5 mL normal saline
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone 10 mg | Experimental | Dexamethasone 10 mg will be given as a single-dose, pre incision, intravenously Receives: Drug: Dexamethasone |
| normal saline | Placebo comparator | Patients in this group will receive 2.5 mL of normal saline intravenously, pre-incision Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
cytokine elevation
Measured: 24 h after surgery
Secondary outcomes (8)
incidence of post thoracotomy pain syndrome
Measured: 3 months after surgery
incidence of post thoracotomy pain syndrome
Measured: 6 months after surgery
incisional and shoulder pain
Measured: acute post operative period
Brief pain inventory questionnaire
Measured: three months after surgery
Brief pain inventory questionnaire
Measured: 6 months after surgery
Leeds Assessment of Neuropathic Signs and Symptoms questionnaire
Measured: three and six months after surgery
cytokine elevation
Measured: 1h after surgery
cytokine elevation
Measured: 48 h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veronique Brulotte, Maisonneuve-Rosemont Hospital
- Investigators
- Veronique Brulotte, MD, Msc, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112864
- Sponsor's protocol ID
- dexaPTPS
- Status last verified
- Mar 2023
- First submitted
- 9 Apr 2014
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dexamethasone on the Post Operative Inflammatory Response and on the Occurrence of Post Thoracotomy Pain Syndrome
- ClinicalTrials.gov ID
- NCT02112864
- Acronym / sponsor ID
- dexaPTPS
- Conditions
- Chronic Pain, Dexamethasone, Thoracic Surgery, Cytokines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone 10 mg | Experimental | Drug: DexamethasoneDexamethasone 10 mg will be given as a single-dose, pre incision, intravenously |
| normal saline | Placebo comparator | Drug: Normal SalinePatients in this group will receive 2.5 mL of normal saline intravenously, pre-incision |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective thoracic surgery using a thoracotomy incision and thoracic epidural analgesia
- ASA I-III
- age 18-75 yo
Key exclusion criteria (4 listed)
- contra-indication to thoracic epidural analgesia
- patient refusal
- patients already taking cortisone or dexamethasone
- patients on chronic opioid medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: decadron10 mg (2.5 ml) | Drug | dexamethasone 10 mg |
| Normal SalineAlso: Placebo2.5 mL normal saline | Drug | normal saline |
Primary outcome
cytokine elevation
Time frame: 24 h after surgery
8 secondary outcomes
incidence of post thoracotomy pain syndrome
Time frame: 3 months after surgery
incidence of post thoracotomy pain syndrome
Time frame: 6 months after surgery
incisional and shoulder pain
Time frame: acute post operative period
Brief pain inventory questionnaire
Time frame: three months after surgery
Brief pain inventory questionnaire
Time frame: 6 months after surgery
Leeds Assessment of Neuropathic Signs and Symptoms questionnaire
Time frame: three and six months after surgery
cytokine elevation
Time frame: 1h after surgery
cytokine elevation
Time frame: 48 h after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronique Brulotte, MD, Msc principal investigator
Maisonneuve-Rosemont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and Normal Saline in people with Chronic Pain and Dexamethasone, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Véronique Brulotte, MD, MSc (514 252-3400 ext. 4558, veronique.brulotte@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cytokine elevation (time frame: 24 h after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.