Wide Awake Open Carpal Tunnel Release With or Without a Tourniquet

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare open carpal tunnel release using local anesthesia with or without a tourniquet. The main questions it aims to answer are: Do the tourniquet cause more procedural pain? Does the use of tourniquet affect the outcome after the procedure? Participants will be randomized to either local anesthesia with a tourniquet or local anesthesia with adrenaline, and undrgo standard open carpal tunnel release.

Official Title
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Wide Awake Open Carpal Tunnel Release With or Without a Tourniquet: a Randomized Single-blinded Controlled Trial

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Drug: Mepivacaine, Combinations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary idiopathic CTS Age 18 or older Symptoms of classic or probable carpal tunnel syndrome according to Katz hand diagram No previous wide awake hand surgical procedures under local anesthesia No planned concomitant procedures Exclusion Criteria: Recurrent carpal tunnel syndrome Vibration induced neuropathy Polyneuropathy Cognitive impairment Anxiety disorder Swedish language insufficiency Active substance abuse Allergy to local anesthesia or adrenaline Patient refusal to participate

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Touniquet<br>Local injection of Mepivacaine (10 mg/ml) approximately 10 ml in the incisional area at least 10 minutes before surgery start. Use of a forearm tourniquet at the pressure of 250 mmHg. | Drug: Mepivacaine, Combinations<br>* Using local anesthesia with adrenaline for intraoperative vasoconstriction instead of a tourniquet.<br>|
| Experimental: Adrenaline<br>Local injection of Mepivacaine (10 mg/ml) and adrenaline (5 mcg/ml) approximately 10 ml in the incisional area at least 10 minutes before surgery start. Forearm tourniquet applied but not inflated. | Drug: Mepivacaine, Combinations<br>* Using local anesthesia with adrenaline for intraoperative vasoconstriction instead of a tourniquet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural pain | Visual analog scale 0 (no pain)-100 (worst possible pain) | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injection pain | Visual analog scale 0 (no pain)-100 (worst possible pain) | Day 1 | 
| Procedure satisfaction | Visual analog scale 0 (best)-100 (worst) | Day 1 | 
| Surgery time | Incision to wound closure (minutes) | Day 1 | 
| Use of diathermy/need to inflate or deflate tourniquet |  | Day 1 | 
| Adverse events |  | 2 weeks | 
| 11-item disabilities of arm, shoulder and hand questionnaire (QuickDASH) | 0 (best)-100 (worse) | 3 months, 1 year | 
| Atroshi-Lyrén scale | 1 (no symptoms)- 5 (worst symptoms) | 3 months, 1 year | 
| Palmar pain scale | 0 (no palmar pain or activity limitation)-100 (worst) | 3 months, 1 year |