Actively Recruiting
Cryoneurolysis for Acute Postoperative Pain Following Total Knee Arthroplasty
Led by Copenhagen University Hospital, Hvidovre · Updated on 2024-07-16
44
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
Sponsors
C
Copenhagen University Hospital, Hvidovre
Lead Sponsor
R
Rigshospitalet, Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 technique is expensive and comprehensive. Pain 24 hours after surgery is associated with high amounts of late acute pain. Therefore, the aim of the current study was to compare the effect of postoperative cryoanalgesia with a sham treatment on acute postoperative pain in TKA patients with moderate to severe pain on the first postoperative day. The cryoanalgesia treatment will be performed 24 hours after surgery. Afterward, the patients will be followed for 24 weeks to determine the level of pain among other outcomes.
CONDITIONS
Official Title
Cryoneurolysis for Acute Postoperative Pain Following Total Knee Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Scheduled for primary unilateral total knee arthroplasty
- Ability to participate by understanding written and spoken Danish and self-reporting pain and satisfaction
- Signed written informed consent form
- Pain score of 45 or higher on a 0-100 scale during a 5-meter walk test 24 hours after surgery
You will not qualify if you...
- Current treatment with systemic glucocorticoids or other immunosuppressants except inhaled steroids
- Insulin-dependent diabetes
- Pregnancy or breastfeeding
- Mental disability affecting informed consent or valid data collection
- Diagnoses of schizophrenia, ongoing psychosis, bipolar disease, or ongoing antipsychotic treatment
- Conditions affecting pain perception such as spinal cord or brain injury, severe polyneuropathies, or neurological disorders
- Posttraumatic osteoarthritis as reason for knee replacement
- Bleeding disorder
- Localized infection in the treatment area
- Cryoglobulinemia, cold urticaria, paroxysmal cold haemoglobinuria, or Raynaud's syndrome
- Use of perioperative peripheral nerve block
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hvidovre Hospital
Hvidovre, Denmark, 2650
Actively Recruiting
Research Team
A
Anders H Springborg, MD
CONTACT
N
Nicolai B Foss, dr.med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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