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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Hvidovre Hospital
RECRUITING
Hvidovre
Contact Information
Primary
Anders H Springborg, MD
andersspringborg@gmail.com
26815919
Backup
Nicolai B Foss, dr.med.
nicolai.bang.foss@regionh.dk
38625328
Time Frame
Start Date: 2024-03-19
Estimated Completion Date: 2025-10
Participants
Target number of participants: 44
Treatments
Experimental: 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).
Sham_comparator: Sham-group
Postoperative sham cryoneurolysis of the lower extremity.
Related Therapeutic Areas
Sponsors
Leads: Copenhagen University Hospital, Hvidovre
Collaborators: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov