About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Cryoneurolysis
- Sham
Treatment groups
Sponsors and collaborators
Copenhagen University Hospital, Hvidovre
Lead sponsor
Rigshospitalet, Denmark
Collaborator