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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Touniquet | Active Comparator | 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. |
|
| Adrenaline | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepivacaine, Combinations | Drug | Using local anesthesia with adrenaline for intraoperative vasoconstriction instead of a tourniquet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural pain | Visual analog scale 0 (no pain)-100 (worst possible pain) | Day 1 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jesper Nordenskjöld, MD, PhD | Contact | 0739706570 | jesper.nordenskjold@skane.se |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D008619 | Mepivacaine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 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 |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |