Status:
NOT_YET_RECRUITING
Cryoanalgesia and Post-thoracotomy Pain in Minimally Invasive Cardiothoracic Surgery
Lead Sponsor:
University of Alberta
Conditions:
Cryotherapy Effect
Post Operative Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Minimally invasive cardiothoracic surgery is often associated with chronic pain syndrome, out of keeping with the extent of surgical dissection. This is thought to be because of damage to the intercos...
Detailed Description
Objective: To characterize the effects of peri-operative intercostal cryoablation for the prevention of post thoracotomy pain following minimally invasive mitral valve surgery or atrial septal defect...
Eligibility Criteria
Inclusion
- Adult patients aged 18 years or older scheduled for elective minimally invasive mitral valve surgery or atrial septal defect repair.
Exclusion
- Patients will be excluded if they are unable to fill in detailed health and pain related questionnaires, psychiatric disease preventing recall or accurate descriptions of pain, chronic pain syndromes, alcohol or illegal substance abuse, or pregnancy. Exclusion criteria also includes chronic use of opioids, allergy to morphine, bupivacaine, and/or ibuprofen, average pain during the last week \>4 on a numerical rating scale from 0 to 10 with 0 indicating "no pain" and 10 indicating "the worst pain imaginable", contraindications to thoracic epidurals, prior chest surgery, or participation in another clinical trial.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05255146
Start Date
September 1 2025
End Date
May 1 2026
Last Update
March 25 2025
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