Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05372393

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

Led by Kuopio University Hospital · Updated on 2025-09-19

118

Participants Needed

1

Research Sites

17 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 a common nerve compression condition in the upper limb. This trial compares two ways of numbing the area during carpal tunnel release (CTR) surgery: local anaesthesia alone versus local anaesthesia combined with a distal median nerve block. The goal is to see if adding the nerve block reduces pain in the first 72 hours after surgery. This is a double-blinded randomized controlled trial aiming to provide evidence on pain management methods for CTS surgery. The study includes two groups of patients undergoing CTR surgery. One group receives local infiltration anaesthesia injected around the planned incision site. The other group receives the same local anaesthesia plus an additional injection near the median nerve above the wrist. Both methods use a specific mixture of lidocaine, bupivacaine, adrenaline, and sodium bicarbonate. The trial involves 59 patients in each group to compare the pain levels experienced after the procedure. Participants will report their pain levels using the Visual Analogue Scale (VAS) during the first 72 hours post-surgery. Researchers also assess pain during anaesthesia injections, operation pain, use of painkillers, and patient satisfaction up to three months after surgery. Safety and adverse events are monitored throughout. The study tracks symptom severity, functional status, and anaesthesia duration to understand the overall impact of the two pain management methods.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Carpal tunnel syndrome confirmed by nerve conduction studies
  • Symptoms suitable for carpal tunnel syndrome surgery
Not Eligible

You will not qualify if you...

  • Recurrent carpal tunnel syndrome
  • Peripheral neuropathies
  • Known allergy to the trial drugs
  • Profound cognitive impairment
  • Pregnancy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of surgery

Participants undergo carpal tunnel release surgery under local anaesthesia with or without distal median nerve block.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - 3 months

Participants are monitored for pain levels and recovery up to 3 months after surgery.

1 visit at 3 months postoperatively

Trial Site Locations

Total: 1 location

1

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

Kuopio, Northern Savonia, Finland, 70210

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Research Team

N

Noora Heikkinen, MBBS

Y

Yrjänä Nietosvaara, Prof.

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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Published Research Related To This Trial

Association between work-related biomechanical risk factors and the occurrence of carpal tunnel syndrome: an overview of systematic reviews and a meta-analysis of current research.

Agnessa Kozak, Grita Schedlbauer, Tanja Wirth...

https://pubmed.ncbi.nlm.nih.gov/26323649