Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06088602

The Effect of Cryoneurolysis for Acute Postoperative Pain Following Total Knee Arthroplasty in High Pain Responders A Randomized, Participant- and Observer-masked, Sham-controlled Trial

Led by Copenhagen University Hospital, Hvidovre · Updated on 2024-07-16

44

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

C

Copenhagen University Hospital, Hvidovre

Lead Sponsor

R

Rigshospitalet, Denmark

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of cryoneurolysis, a technique that freezes peripheral sensory nerves, to reduce acute postoperative pain in patients undergoing total knee arthroplasty (TKA) who experience moderate to severe pain on the first day after surgery. This study compares cryoneurolysis with a sham treatment to see if it can lower pain levels during the first week after surgery and follows patients for 24 weeks to assess ongoing pain and other outcomes. The research is important because while current pain treatments exist, some patients still have significant pain that delays recovery and increases opioid use. The intervention involves performing cryoneurolysis on the superficial genicular nerves about 20-32 hours after TKA surgery using a cold probe guided by ultrasound and nerve stimulation. The procedure freezes specific nerve branches to block pain signals temporarily. The control group receives a sham procedure identical in setup but without actual freezing. Both groups receive standard multimodal pain management including paracetamol, NSAIDs, steroids, and local infiltration analgesia. Patients are treated under general or spinal anesthesia according to local protocols. Participants are closely monitored through pain ratings collected twice daily during the first week, with follow-up assessments at 2, 4, 12, and 24 weeks post-surgery. Pain is measured at rest, during walking tests, and during sleep using a visual analog scale. Researchers also track opioid use, side effects like dizziness or nausea, quality of sleep, and any adverse events. Other data collected include demographics, surgical details, and questionnaires on pain and psychological factors. The main outcome is cumulative pain during walking in days 2 to 7 after surgery, with safety and longer-term pain outcomes also assessed.

CONDITIONS

Brief Title

Cryoneurolysis for Acute Postoperative Pain Following Total Knee Arthroplasty

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Primary unilateral total knee arthroplasty
  • Ability to participate by understanding Danish and reporting pain and satisfaction
  • Signed written informed consent form
  • Pain score of 45 or higher on a 0-100 scale during a 5-meter walk test at 24 hours after surgery
Not Eligible

You will not qualify if you...

  • Ongoing systemic glucocorticoid or immunosuppressant treatment (excluding inhaled steroids)
  • Insulin-dependent diabetes
  • Pregnancy or breastfeeding
  • Mental disability impairing informed consent or valid data collection
  • Diagnoses of schizophrenia, ongoing psychosis, bipolar disease, or ongoing antipsychotic treatment
  • Altered pain perception due to other diseases or injuries such as spinal cord injury or severe neuropathies
  • Posttraumatic osteoarthritis as reason for surgery
  • Bleeding disorders
  • Localized infection in the treatment area
  • Cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, or Raynaud's syndrome
  • Perioperative peripheral nerve block

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From surgery up to 7 days after surgery

Participants undergo total knee arthroplasty surgery followed by either cryoneurolysis or a sham procedure to reduce postoperative pain.

1 baseline visit at surgery and intervention 20-32 hours after surgery

Follow-up

Duration - Up to 24 weeks after surgery

Participants report pain and side effects and are evaluated at multiple time points after treatment to monitor recovery and analgesic effects.

Telephone follow-ups at 2, 4, 12, and 24 weeks after surgery

Trial Site Locations

Total: 1 location

1

Hvidovre Hospital

Hvidovre, Denmark, 2650

Actively Recruiting

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Research Team

A

Anders H Springborg, MD

N

Nicolai B Foss, dr.med.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Efficacy of thoracic epidural analgesia with or without intercostal nerve cryoanalgesia for postthoracotomy pain.

Seppo T Mustola, Jukka Lempinen, Eija Saimanen...

https://pubmed.ncbi.nlm.nih.gov/21353017

A Multimodal Pain Management Protocol Including Preoperative Cryoneurolysis for Total Knee Arthroplasty to Reduce Pain, Opioid Consumption, and Length of Stay.

Joshua A Urban, Kandice Dolesh, Erin Martin

https://pubmed.ncbi.nlm.nih.gov/34286056