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

September 15, 2025 updated by: Kuopio University Hospital

Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block - a Protocol of a Double Blinded Randomised Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Finland
    • Northern Savonia
      • Kuopio, Northern Savonia, Finland, 70210
        • Recruiting
        • Kuopio University hospital, Department of Orthopaedics, Traumatology and Hand Surgery
        • Sub-Investigator:
          • Noora Heikkinen
        • Sub-Investigator:
          • Mikko Räisänen
        • Sub-Investigator:
          • Mikael Hytönen
        • Sub-Investigator:
          • Aukusti Savolainen
        • Sub-Investigator:
          • Joonas Sirola
        • Sub-Investigator:
          • Aleksi Reito
        • Principal Investigator:
          • Yrjänä Nietosvaara
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Local infiltration anaesthesia in carpal tunnel release
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
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.
Experimental: Distal median nerve block with local infiltration anaesthesia in carpal tunnel release
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The pain level perceived by the patient after the procedure using Visual Analogue Scale (VAS)
Time Frame: Postoperatively during the first 72 hours after the operation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure pain (VAS)
Time Frame: Immediately after the infiltration of anaesthetic solution
The investigators ask the patients to evaluate the pressure pain that the infiltration of the anaesthetic solution caused using Visual Analogue Scale (VAS). 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.
Immediately after the infiltration of anaesthetic solution
Burning pain (VAS)
Time Frame: Immediately after the infiltration of anaesthetic solution
The investigators ask the patients to evaluate the burning pain that the infiltration of the anaesthetic solution caused using Visual Analogue Scale (VAS). 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.
Immediately after the infiltration of anaesthetic solution
Needle sting pain (VAS)
Time Frame: Immediately after the infiltration of anaesthetic solution
The investigators ask the patients to evaluate the needle sting pain that the infiltration of the anaesthetic solution caused using Visual Analogue Scale (VAS). 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.
Immediately after the infiltration of anaesthetic solution
Total pain during the injection of the anaesthetic solution (VAS)
Time Frame: Immediately after the infiltration of anaesthetic solution
The investigators ask the patients to evaluate the total pain that the infiltration of the anaesthetic solution caused using Visual Analogue Scale (VAS). 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.
Immediately after the infiltration of anaesthetic solution
Worst pain during the operation (VAS)
Time Frame: Immediately after the operation
The investigators ask the patients to evaluate the worst pain during the operation using Visual Analogue Scale (VAS). 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.
Immediately after the operation
Duration of anaesthesia
Time Frame: Postoperatively during the first 72 hours after the operation
The investigators assess the length of the anaesthesia by asking the patients to fill an online form when they first time feel pain in the operation field or have to use pain killers.
Postoperatively during the first 72 hours after the operation
Self-reported symptom severity and functional status
Time Frame: Before and 3 months postoperatively
The investigators ask the patients to evaluate their symptoms using Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) score. It consists of the Symptom Severity Scale (SSS) containing 11 questions, and it uses a five-point Likert rating scale from 1 (no symptoms) to 5 (most severe symptoms), and Functional Status Scale (FSS), which has 8 questions assessing the degree of complaints on a five-point Likert scale from 1 (no symptoms) to 5 (most severe symptoms). Mean sum scores of both scales are calculated and used for analysis.
Before and 3 months postoperatively
Patient satisfaction
Time Frame: 3 months postoperatively
Patients evaluate how likely they would recommend the procedure to a fellow man using Net Promoter Score (NPS). Net Promoter Score is a measurement taken from asking patients how likely they are to recommend the procedure to others on a scale of 0-10. The higher score the better outcome.
3 months postoperatively
Adverse events (AE)
Time Frame: 3 months postoperatively
Health care professional assessment
3 months postoperatively
Expected pain (VAS)
Time Frame: Before the infiltration of the anaesthetic solution
The investigators ask the patient to evaluate the pain during the infiltration of the anaestetic solution using Visual Analogue Scale (VAS). 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.
Before the infiltration of the anaesthetic solution
Amount of perceived needle stings
Time Frame: Immediately after the infiltration of anaesthetic solution
The investigators ask the patient to report how many needle stings they felt when the anaesthesia was performed.
Immediately after the infiltration of anaesthetic solution
Consumption of pain killers
Time Frame: Postoperatively during the first 72 hours after the operation
The investigators record the consumption of pain killers after surgery
Postoperatively during the first 72 hours after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Collaborators

University of Eastern Finland

Investigators

  • Study Director: Yrjänä Nietosvaara, Prof., Kuopio University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

May 9, 2022

First Posted (Actual)

May 12, 2022

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5203140

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This trial will share data with researchers who submit a methodologically sound proposal after its completion, as well as with reviewers of the journal where the trial results will be published, if necessary.

IPD Sharing Time Frame

Data will be available for 15 years after the study has ended.

IPD Sharing Access Criteria

Request must come from an EU/ETA country. The investigators do not share data outside these countries.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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