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New treatment option for Acute Postoperative Pain
Official title Cryoneurolysis for Acute Postoperative Pain Following Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT06088602
What this study is testing
- What it's testing
- Cryoneurolysis is a regional anaesthetic technique that works by freezing peripheral sensory nerves. This technique can potentially provide analgesia after total knee arthroplasty (TKA).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hvidovre, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hvidovre, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.