NCT05372393 Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block
| NCT ID | NCT05372393 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kuopio University Hospital |
| Condition | Carpal Tunnel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 118 participants |
| Start Date | 2022-09-21 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 118 participants in total. It began in 2022-09-21 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Carpal tunnel syndrome (CTS) is the most commonly appearing entrapment neuropathy of the upper extremity. Treatment options include both non-operative and operative methods. Surgical treatment, carpal tunnel release (CTR), involves division of the transverse carpal ligament. Surgery can be performed under axillary or intravenous block, or general anaesthesia. There are no prior randomised controlled trials (RCT) comparing local infiltration anaesthesia to local infiltration anaesthesia augmented with a distal median nerve block in CTR. The aim of this trial is to investigate whether adding a distal median nerve block to local anaesthesia reduces the patient's perceived pain level for up to 72 hours after CTR, compared to using only local anaesthesia, i.e., an anaesthesia mixture injected solely in and around the planned incision and nerve release. The null hypothesis is that the use of distal median nerve block with local anaesthesia does not reduce pain after CTR compared to pure local anaesthesia. PERSONNEL (carPal tunnEl ReleaSe lOcal iNfiltratioN mEdian bLockade) is a double-blinded, i.e., patient and investigators, RCT in patients with CTS. Patients will be randomly divided into two parallel trial groups, 1:1 in size to each other. Fifty-nine patients will be needed for each group to have adequate power. The primary outcome is the pain level perceived by the patient after the procedure during the first 72 hours using the Visual Analogue Scale (VAS). Secondary outcomes include patient-rated outcome measures, safety, the entire consumption of pain killers after the surgery during the first 72 hours postoperatively, pain of performing the anaesthesia, and pain during and after the operation. No trial comparing local anaesthesia to local anaesthesia augmented with distal median nerve block has been published before. There is also no trial noting individual tolerance to pain. The quality of the median nerve block at the wrist has been achieved by using sensory or sensory-motor nerve stimulation and has been proven effective. This increases trust in the effectiveness of the treatment method, but it still needs to be adequately proven which is the goal of this trial.
Eligibility Criteria
Inclusion Criteria: * ≥18 years of age * CTS verified by nerve conduction studies * Symptoms suitable for CTS Exclusion Criteria: * Recurrent CTS * Peripheral neuropathies * Known allergy to the trial drugs * Profound cognitive impairment * Pregnancy
Contact & Investigator
Yrjänä Nietosvaara, Prof.
STUDY DIRECTOR
Kuopio University Hospital
Frequently Asked Questions
Who can join the NCT05372393 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carpal Tunnel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05372393 currently recruiting?
Yes, NCT05372393 is actively recruiting participants. Contact the research team at noorheik@student.uef.fi for enrollment information.
Where is the NCT05372393 trial being conducted?
This trial is being conducted at Kuopio, Finland.
Who is sponsoring the NCT05372393 clinical trial?
NCT05372393 is sponsored by Kuopio University Hospital. The principal investigator is Yrjänä Nietosvaara, Prof. at Kuopio University Hospital. The trial plans to enroll 118 participants.