MedTrace Logo

Cryoneurolysis for Acute Postoperative Pain Following Total Knee Arthroplasty

NCT06088602 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-07-16

No results posted yet for this study

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

Interventions

PROCEDURE

Cryoneurolysis

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.

PROCEDURE

Sham

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.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Copenhagen University Hospital, Hvidovre

    lead OTHER

Principal Investigators

  • Anders H Springborg, MD · Copenhagen University Hospital, Hvidovre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-19
Primary Completion
2025-06-30
Completion
2025-10-31

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06088602 on ClinicalTrials.gov