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Recruiting NCT06088602

Cryoneurolysis for Acute Postoperative Pain Following Total Knee Arthroplasty

Trial Parameters

Condition Acute Postoperative Pain
Sponsor Copenhagen University Hospital, Hvidovre
Study Type INTERVENTIONAL
Phase N/A
Enrollment 44
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-03-19
Completion 2025-06
Interventions
CryoneurolysisSham

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 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.

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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 osteoarthri

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