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Can freezing nerves before knee replacement cut opioid use?

NCT ID NCT05840276

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether freezing specific nerves around the knee before total knee replacement surgery can reduce pain and the need for opioids afterward. One hundred adults scheduled for knee replacement will either receive the nerve-freezing treatment or a sham procedure. The main goal is to see if the freezing group uses less morphine in the first two weeks after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cryoneurolysis (nerve freezing using a device called VISUAL-ICE)
What this could lead to
If it works, this could offer a way to reduce pain and opioid use after knee replacement surgery, helping patients recover faster.
What could go wrong
This is a small, early-stage trial with only 100 participants. The sham control may not fully blind patients, and nerve freezing carries risks like temporary numbness or nerve damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Scheduled for unilateral, primary total knee arthroplasty * Age ≥ 18y * Written and oral understanding of Danish. Exclusion Criteria: * Contraindications against ibuprofen or paracetamol, for example previous gastric ulcer, or known renal failure (eGRF \< 60 ml/kg/1,73m2), known thrombocytopenia (\< 100 bil/l); or against treatment with morphine * History of neuropathic pain * Previous recipient of cryoneurolysis for the knee * Patients with daily use of high dose opioid (\> oral morphine 30 mg/day or oxycodone 30 mg/day or tramadol 150 mg/day) or any use of other opioids including methadone and transdermal opioids * Uncontrolled serious disease (cancer, diabetes, etc.) * Disease associated with reactions to cold, such as cryoglobulinemia, cold urticarial and Reynaud's syndrome.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hospital of Southwest Jutland

    Esbjerg, Region Syddanmark, 6700, Denmark

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