Actively Recruiting
Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block
Led by Kuopio University Hospital · Updated on 2025-09-19
118
Participants Needed
1
Research Sites
184 weeks
Total Duration
On this page
Sponsors
K
Kuopio University Hospital
Lead Sponsor
U
University of Eastern Finland
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Confirmed carpal tunnel syndrome by nerve conduction studies
- Symptoms appropriate for carpal tunnel syndrome
You will not qualify if you...
- Previous carpal tunnel surgery on the affected wrist
- Other peripheral nerve disorders
- Known allergy to the study anaesthetic drugs
- Severe cognitive impairment
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Kuopio University hospital, Department of Orthopaedics, Traumatology and Hand Surgery
Kuopio, Northern Savonia, Finland, 70210
Actively Recruiting
Research Team
N
Noora Heikkinen, MBBS
CONTACT
Y
Yrjänä Nietosvaara, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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