NCT06088602 Cryoneurolysis for Acute Postoperative Pain Following Total Knee Arthroplasty
| NCT ID | NCT06088602 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Copenhagen University Hospital, Hvidovre |
| Condition | Acute Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2024-03-19 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2024-03-19 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Anders H Springborg, MD
PRINCIPAL INVESTIGATOR
Copenhagen University Hospital, Hvidovre
Frequently Asked Questions
Who can join the NCT06088602 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06088602 currently recruiting?
Yes, NCT06088602 is actively recruiting participants. Contact the research team at andersspringborg@gmail.com for enrollment information.
Where is the NCT06088602 trial being conducted?
This trial is being conducted at Hvidovre, Denmark.
Who is sponsoring the NCT06088602 clinical trial?
NCT06088602 is sponsored by Copenhagen University Hospital, Hvidovre. The principal investigator is Anders H Springborg, MD at Copenhagen University Hospital, Hvidovre. The trial plans to enroll 44 participants.