Carpal Tunnel Release Under Local Infiltration Anaesthesia Versus Local Infiltration Anaesthesia and Median Nerve Block

Study Overview
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Brief Summary
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Carpal tunnel syndrome (CTS) is the most common 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, local, axillary- or intravenous block or general anaesthesia. There are no randomised controlled trials (RCT), comparing local infiltration anaesthesia to local infiltration anaesthesia augmented with distal median nerve block in CTR. The investigators' aim is to find out if distal median nerve block in adjunct to WALANT surgery reduces pain during CTR and postoperatively. The investigators' primary hypothesis is that distal median nerve block, in adjunct to local infiltration anaesthesia does not reduce pain during and after CTR compared to pure local anaesthesia. The study is a blinded randomized controlled trial in patients with CTR. Patients will be randomly divided into two study groups. CTR is performed under WALANT. The first group will have local infiltration anaesthesia and distal median nerve block and the other local infiltration anaesthesia. The primary outcome measure is the pain level perceived by patient during the procedure using the visual analogue scale (VAS). CTR is the most common hand surgical procedure, which is well suited for WALANT. The optimal method of local anaesthesia is however not clear. Possible advantages or disadvantages of median nerve blockade in adjunct to local infiltration anaesthesia can be assessed by a high-quality RCT.

Official Title
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Carpal Tunnel Release Under Local Infiltration Anaesthesia Versus Local Infiltration Anaesthesia and Median Nerve Block- a Study Protocol of a Blinded Randomized Controlled Trial.

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Procedure: Distal median nerve block and local infiltration anaesthesia
* Procedure: Local infiltration anaesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 17 years of age with CTS verified by nerve conduction studies Exclusion Criteria: Patients under 18 years, previous or recurrent carpal tunnel syndrome, repeat surgery, peripheral neuropathies like cervical radiculopathy and cubital tunnel syndrome, known allergy to the trial drugs, profound cognitive impairment, and pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two concurrent study groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Local infiltration anaesthesia<br>The investigators allocate 59 patients in this arm. It serves as the control group, who receives local infiltration anaesthesia. | Procedure: Local infiltration anaesthesia<br>* The anaesthetic cocktail consists of 4,5 ml of lidocaine with adrenalin 1%, 4,5 ml of bupivacaine with adrenalin 0.5% and 1 ml of (7.5%) sodium bicarbonate. The investigators use a 24 gauge hypodermic needle to inject the solution.<br>|
| Experimental: Local infiltration anaesthesia and distal median nerve block<br>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 and local infiltration anaesthesia<br>* Local infiltration anaesthesia: The anaesthetic cocktail consists of 4,5 ml of lidocaine with adrenalin 1%, 4,5 ml of bupivacaine with adrenalin 0.5% and 1 ml of (7.5%) sodium bicarbonate. The investigators use a 24 gauge hypodermic needle to inject the solution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pain level perceived after the procedure using visual analogue scale (VAS) | The investigators measure the pain level perceived after the procedure every fourth hour while awake until third night postoperatively using VAS. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. | Postoperatively 72 hours after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain sensitivity using PCS-FINv2.0 form | The investigators evaluate pain sensitivity between patients using PCS-FINv2.0 form. The investigators ask patients to fill pain catastrophizing tendency evaluating form before the surgery in order to evaluate the pain levels between the experimental and control group. | Preoperatively | 
| Expected pain level during the injection of the anesthetic solution using visual analogic scale (VAS) | The difference between the expected pain during the injection of the anesthetic solution using visual analogic scale (VAS). The investigators ask the patients to evaluate the pain they expect to experience during procedure. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. | Preoperatively | 
| Duration of anaesthesia | The investigators assess the length of the anaesthesia by asking the patients to fill online form when they first time feel pain in the operation field or have to use pain killers. | Postoperatively | 
| Patients' symptom severity and overall functional status | 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 after the surgery | 
| Consumption of pain killers | The investigators record the consumption of pain killers after surgery | After the surgery until 3rd postoperative night | 
| Patient satisfaction | Patients evaluate how likely they would recommend the procedure to the fellowman 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 after the surgery | 
| Number of experienced needle stings | The investigators ask the patient to report how many needle stings they felt when the investigators performed the anaesthesia | Immediately after the injection of local anaesthetic. | 
| Pain caused by needle sting-, tension- and burning | The investigators record pain perceived during the injection of the anaesthetic solution caused by needle sting-, tension- and burning using VAS | Postoperatively, immediately after the procedure | 
| The most intense pain during the procedure with visual analogic scale (VAS) | The investigators evaluate the highest level of pain perceived by patient during the procedure using visual analogic scale. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. | Visual analogic scale is recorded immediately after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, carpal tunnel release, carpal tunnel syndrome, local infiltration anaesthesia, local anaesthesia, median nerve block, wide-awake local anaesthesia with no tourniquet, nerve block anaesthesia