Status:
RECRUITING
Cryoneurolysis for Acute Postoperative Pain Following Total Knee Arthroplasty
Lead Sponsor:
Copenhagen University Hospital, Hvidovre
Collaborating Sponsors:
Rigshospitalet, Denmark
Conditions:
Acute Postoperative Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Cryoneurolysis is a regional anaesthetic technique that works by freezing peripheral sensory nerves. This technique can potentially provide analgesia after total knee arthroplasty (TKA). However, the ...
Detailed Description
Background Total knee arthroplasty (TKA) is a frequently performed procedure and is expected to increase in numbers due to the aging population and growing obesity rates. Fast-track regimes with multi...
Eligibility Criteria
Inclusion
- Age ≥ 18
- Primary unilateral total knee arthroplasty
- Ability to participate in the study (understand written and spoken Danish language, self-reported pain and satisfaction)
- Signed written informed consent form
- Pain (VAS 0-100 mm) ≥ 45 during a 5-meter walk test at 24 h (20-28h) postoperatively
Exclusion
- Ongoing treatment of systemic glucocorticoids or other immunosuppressant treatment apart from inhaled steroids
- Insulin-dependent diabetes
- Pregnancy or breastfeeding
- Mental disability that could impair a patient's decision-making capability of giving informed consent and not enabling valid data collection.
- Patients with known diagnoses of schizophrenia, ongoing psychosis, bipolar disease and/or a history of ongoing anti-psychotic treatment.
- Patients with modulated pain-reception (experience) based on other diseases or injuries, e.g. spinal cord or brain injury, severe polyneuropathies or neurologic disorders.
- Posttraumatic osteoarthritis as reason for total knee arthroplasty
- Bleeding disorder
- Localized infection in the treatment area
- Cryoglobulinemia, cold urticaria, paroxysmal cold haemoglobinuria, or Raynaud's syndrome
- Perioperative peripheral nerve block
Key Trial Info
Start Date :
March 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06088602
Start Date
March 19 2024
End Date
October 1 2025
Last Update
July 16 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hvidovre Hospital
Hvidovre, Denmark, 2650