Wide Awake Open Carpal Tunnel Release With or Without a Tourniquet

Region Skane

Status: Not yet enrolling

Conditions: Carpal Tunnel Syndrome

Treatments: Drug: Mepivacaine, Combinations

Study type: Interventional

Funder types: Other

Identifiers

NCT06172400

2020-04670

Details and patient eligibility

About

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:

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Touniquet

Active Comparator group

Description:

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.

Treatment:

Drug: Mepivacaine, Combinations

Adrenaline

Experimental group

Description:

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.

Treatment:

Drug: Mepivacaine, Combinations