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Dexamethasone for Reduction of Post Thoracotomy Pain Syndrome

M

Maisonneuve-Rosemont Hospital

Status

Enrolling

Conditions

Chronic Pain
Cytokines
Thoracic Surgery
Dexamethasone

Treatments

Drug: Normal Saline
Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT02112864
dexaPTPS

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups, including a placebo group

dexamethasone 10 mg
Experimental group
Description:
Dexamethasone 10 mg will be given as a single-dose, pre incision, intravenously
Treatment:
Drug: Dexamethasone
normal saline
Placebo Comparator group
Description:
Patients in this group will receive 2.5 mL of normal saline intravenously, pre-incision
Treatment:
Drug: Normal Saline

Trial contacts and locations

1

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Central trial contact

Véronique Brulotte, MD, MSc; Nadia Godin, nurse

Data sourced from clinicaltrials.gov

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