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NCT05372393 | Recruiting | Carpal Tunnel Syndrome


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

Kuopio University Hospital

Brief Summary:

Carpal tunnel syndrome is the most commonly appearing entrapment neuropathy of the upper extremity. Treatment options include both non-operative and surgical methods. Surgical treatment, carpal tunnel release (CTR), involves division of the transverse carpal ligament. Surgery can be done under an axillary- or intravenous block, or local or general anaesthesia. There are no randomised controlled trials comparing local infiltration anaesthesia with or without a distal median nerve block in carpal tunnel release. The aim of the study is to investigate whether a distal median nerve block, in addition to local anaesthesia in carpal tunnel release, reduces pain during and after the procedure. 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. This trial is a randomised controlled trial involving patients with carpal tunnel syndrome. Patients will be randomized into two study groups: local anaesthesia and local with a distal median nerve block. Fifty-nine patients will be needed for each group to have adequate power. The primary outcome is the pain level after the procedure for 72 hours using visual analogue scale. The secondary outcomes include expected pain; pain during the injection of the anaesthetic solution caused by pressure, burning, needle sting, and total pain; worst pain during the surgery; duration of anaesthesia; number of experienced needle stings; Boston Carpal Tunnel Syndrome Questionnaire; pain killer consumption, patient satisfaction, and safety . 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. Distal median block in CTR is believed to reduce pain intra- and postoperatively. However, the superiority of distal median block with local anaesthesia compared to pure local anaesthesia alone has not been proven.

Condition or disease

Carpal Tunnel Syndrome

Intervention/treatment

Local infiltration anaesthesia in carpal tunnel release

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

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 118 participants
Masking: Double
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block - a Protocol of a Double Blinded Randomized Controlled Trial
Actual Study Start Date : September 21, 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : September 2027
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

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

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Over 17 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

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

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

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Locations


Recruiting

Finland, Pohjois-Savo

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

Kuopio, Pohjois-Savo, Finland, 70210

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