Freezing nerves to relieve pain after knee surgery
The Effect of Cryoneurolysis for the Treatment of Acute Postoperative Pain Following Total Knee Arthroplasty in High Pain Responders - A Randomized, Participant- and Observer-masked, Sham-controlled Trial
This study is testing if freezing nerves can help people with knee surgery feel less pain after their operation compared to a fake treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Copenhagen University Hospital, Hvidovre Academic / other |
| Locations | 1 site (Hvidovre) |
| Trial ID | NCT06088602 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of cryoneurolysis, a technique that freezes peripheral sensory nerves, in managing acute postoperative pain following total knee arthroplasty (TKA). Patients experiencing moderate to severe pain 24 hours after surgery will receive either cryoanalgesia or a sham treatment. The study aims to compare pain levels and other outcomes over a 24-week follow-up period. This approach seeks to improve pain management and reduce reliance on opioids in the postoperative setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing primary unilateral total knee arthroplasty and have moderate to severe pain post-surgery.
Not a fit: Patients with ongoing systemic glucocorticoid treatment, insulin-dependent diabetes, or significant mental disabilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could significantly reduce postoperative pain and improve recovery times for knee surgery patients.
How similar studies have performed: While cryoneurolysis has shown promise in treating pain in other surgical contexts, its application in TKA is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hvidovre
- Hvidovre Hospital — Hvidovre, Denmark (Recruiting)
Study contacts
- Principal investigator: Anders H Springborg, MD — Copenhagen University Hospital, Hvidovre
- Study coordinator: Anders H Springborg, MD
- Email: andersspringborg@gmail.com
- Phone: 26815919
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.