Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block

NCT05372393 | Recruiting

• 1 other identifier: KUH5203140
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome; carpal tunnel release; local anaesthesia; surgery; wide-awake local anaesthesia with no tourniquet; nerve block

Outcome Measures

Primary Outcomes (1)

• The pain level perceived by the patient after the procedure using Visual Analogue Scale (VAS)

  The investigators measure the pain level perceived by the patient after the procedure every fourth hour while awake until third night postoperatively using VAS. The first assessment is performed four hours after the surgery. The mean VAS is calculated from all time points over the 72-hour period. The Visual analogue Scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable.

  Postoperatively during the first 72 hours after the operation

Secondary Outcomes (12)

• Pressure pain (VAS)

  Immediately after the infiltration of anaesthetic solution

• Burning pain (VAS)

  Immediately after the infiltration of anaesthetic solution

• Needle sting pain (VAS)

  Immediately after the infiltration of anaesthetic solution

• Total pain during the injection of the anaesthetic solution (VAS)

  Immediately after the infiltration of anaesthetic solution

• Worst pain during the operation (VAS)

  Immediately after the operation

Study Arms (2)

Local infiltration anaesthesia in carpal tunnel release

ACTIVE COMPARATOR

The investigators allocate 59 patients in this arm. It serves as the control group, who receives local infiltration anaesthesia.

Procedure: Local infiltration anaesthesia in carpal tunnel release

Distal median nerve block with local infiltration anaesthesia in carpal tunnel release

EXPERIMENTAL

The investigators allocate 59 patients in this arm. It serves as the experimental group, who receives local infiltration anaesthesia and distal median nerve block.

Procedure: Distal median nerve block with local infiltration anaesthesia in carpal tunnel release

Interventions

Local infiltration anaesthesia in carpal tunnel release PROCEDURE

The anaesthetic cocktail consists of 1 ml of (7.5%) sodium bicarbonate (Natriumbicarbonate Braun 75mg/ml), 4,5 ml of lidocaine with adrenaline 1% (Lidocain cum adrenalin 10 mg/ml), 4,5 ml of bupivacaine with adrenaline 0.5% (Marcain cum adrenalin 5mg/ml +5 µg/ml). The anaesthetic cocktail must be prepared in the above-mentioned order to avoid possible precipitation. A 24-gauge hypodermic needle and 10 ml syringe are used to inject the solution. The care provider pinches from the area of median nerve blockade prior to performing local anaesthesia. All the anaesthetic solution is injected locally. Additional anaesthetic solution can be injected locally if necessary.

Local infiltration anaesthesia in carpal tunnel release

Distal median nerve block with local infiltration anaesthesia in carpal tunnel release PROCEDURE

The anaesthetic cocktail consists of 1 ml of (7.5%) sodium bicarbonate (Natriumbicarbonate Braun 75mg/ml), 4,5 ml of lidocaine with adrenaline 1% (Lidocain cum adrenalin 10 mg/ml), 4,5 ml of bupivacaine with adrenaline 0.5% (Marcain cum adrenalin 5mg/ml +5 µg/ml). The anaesthetic cocktail must be prepared in the above-mentioned order to avoid possible precipitation. A 24-gauge hypodermic needle and 10 ml syringe are used to inject the solution. Half of the anaesthetic solution is injected into the median nerve area 5-7 cm proximally from the distal wrist crease. The other half is injected locally. Additional anaesthetic solution can be injected locally if necessary.

Distal median nerve block with local infiltration anaesthesia in carpal tunnel release

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• CTS verified by nerve conduction studies
• Symptoms suitable for CTS

You may not qualify if:

• Recurrent CTS
• Peripheral neuropathies
• Known allergy to the trial drugs
• Profound cognitive impairment
• Pregnancy

Sponsors & Collaborators

• Kuopio University Hospital: lead
• University of Eastern Finland: collaborator

Study Sites (1)

Kuopio University hospital, Department of Orthopaedics, Traumatology and Hand Surgery

Kuopio, Northern Savonia, 70210, Finland

RECRUITING

Related Publications (25)

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• Heikkinen N, Nietosvaara Y, Reito A, Sirola J, Hytonen M, Savolainen A, Raisanen MP. Carpal tunnel release under local anesthesia with or without distal median nerve block: Double-blind randomized clinical trial. Scand J Surg. 2025 Mar;114(1):13-21. doi: 10.1177/14574969241277028. Epub 2024 Sep 19.

  PMID: 39297416 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Yrjänä Nietosvaara, Prof.

  Kuopio University Hospital

  STUDY DIRECTOR

Central Study Contacts

Noora Heikkinen, MBBS

CONTACT

+358504421930; noorheik@student.uef.fi

Yrjänä Nietosvaara, Prof.

CONTACT

+358447176883; yrjana.nietosvaara@pshyvinvointialue.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Masking is double blinded (patient and investigators). The trial patients are blinded to the randomization. They can't see to the operation field. In the local anaesthesia group care provider pinches from the area of median nerve blockade prior to performing local anaesthesia.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two concurrent study groups

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 12, 2022
• Study Start: September 21, 2022
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available for 15 years after the study has ended.
• Access Criteria: Request must come from an EU/ETA country. The investigators do not share data outside these countries.

Locations

FI (1)