Wide Awake Open Carpal Tunnel Release With or Without a Tourniquet
NCT ID: NCT06172400
Last Updated: 2023-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2024-01-09
2025-12-31
Brief Summary
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1. Do the tourniquet cause more procedural pain?
2. 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Touniquet
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.
Mepivacaine, Combinations
Using local anesthesia with adrenaline for intraoperative vasoconstriction instead of a tourniquet.
Adrenaline
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.
Mepivacaine, Combinations
Using local anesthesia with adrenaline for intraoperative vasoconstriction instead of a tourniquet.
Interventions
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Mepivacaine, Combinations
Using local anesthesia with adrenaline for intraoperative vasoconstriction instead of a tourniquet.
Eligibility Criteria
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Inclusion Criteria
* 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
* Vibration induced neuropathy
* Polyneuropathy
* Cognitive impairment
* Anxiety disorder
* Swedish language insufficiency
* Active substance abuse
* Allergy to local anesthesia or adrenaline
* Patient refusal to participate
18 Years
ALL
No
Sponsors
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Region Skane
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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2020-04670
Identifier Type: -
Identifier Source: org_study_id