Cryoneurolysis for Acute Postoperative Pain Following Total Knee Arthroplasty

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCopenhagen University Hospital, Hvidovre

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

44 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Copenhagen University Hospital, Hvidovre

Lead sponsor

Rigshospitalet, Denmark

Collaborator