Cryoneurolysis for Acute Postoperative Pain Following Total Knee Arthroplasty

NCT06088602 | Recruiting

• 1 other identifier: CryoTKA
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Postoperative Pain

Keywords

Cryoanalgesia; Acute postoperative pain; Total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Cumulated pain during walking days 2-7

  Cumulated pain (VAS 0-100 mm) upon ambulation in a 5-meter walk test on days 2-7 postoperatively after surgery.

  Days 2-7 after surgery

Secondary Outcomes (13)

• Pain at follow-ups

  2-24 weeks after surgery

• Pain relief after block

  24 hours after surgery

• Cumulated pain during rest and night days 2-7

  Days 2-7 after surgery

• Quality of sleep

  Days 2-7 after surgery

• Dizziness

  Days 2-7 after surgery

Study Arms (2)

Cryo-group

EXPERIMENTAL

Postoperative cryoneurolysis of the superficial genicular nerves, i.e., the infrapatellar branches of the saphenous nerve (ISN) and the anterior femoral cutaneous nerve (AFCN).

Procedure: Cryoneurolysis

Sham-group

SHAM COMPARATOR

Postoperative sham cryoneurolysis of the lower extremity.

Procedure: Sham

Interventions

Cryoneurolysis PROCEDURE

Local anesthesia is injected in the skin. The superficial genicular nerves, more specifically the ISN and the AFCN, are visualized. A nerve stimulator is used to verify the visualized nerves., 2-3 ml of ropivacaine 5 mg/ml is injected around the nerves. After 5-15 minutes the effect is evaluated by assessing pain in the surgical area and asking the patient whether there is a pain relief. Following this evaluation, cryoneurolysis (Cryo-S, Metrum Cryoflex, Blizne Laszczynskiego, Poland) is performed unilaterally along a treatment line, the location of which was guided by visualization and palpation of anatomic landmarks. The ISN treatment line is located along the line that connects a point located 5 cm medial to the lower pole of the patella and a point located 5 cm medial to the tibial tubercle. The AFCN treatment line is located at one-third the length of the distance from the center of the patella to the top of the femur, with a width equal to the width of the patella.

Cryo-group

Sham PROCEDURE

The exact same procedure as in the cryo-group is performed, except that the nerves are not frozen with the cryoneurolysis apparatus. Sound effects from the machine are replicated to give the patient the same experience as in the active intervention group.

Sham-group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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 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

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Hvidovre Hospital

Hvidovre, 2650, Denmark

RECRUITING

Related Publications (33)

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MeSH Terms

Conditions

Pain, Postoperative

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Anders H Springborg, MD

  Copenhagen University Hospital, Hvidovre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anders H Springborg, MD

CONTACT

26815919; andersspringborg@gmail.com

Nicolai B Foss, dr.med.

CONTACT

38625328; nicolai.bang.foss@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Anaesthesiologist performing intervention is unblinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: The patients will be randomized to 2 groups with 22 in each. Sham cryo (sham-group): Postoperative sham cryoneurolysis of the lower extremity. Cryoneurolysis (cryo-group): Postoperative cryoneurolysis of the superficial genicular nerves, i.e., the infrapatellar branches of the saphenous nerve (ISN) and the anterior femoral cutaneous nerve (AFCN).

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 18, 2023
• Study Start: March 19, 2024
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available after the study is successfully published. There is no end date to the availability of the data.

Locations

DK (1)