Wide Awake Open Carpal Tunnel Release With or Without a Tourniquet

Not Applicable

Not yet recruiting

• Conditions: Carpal Tunnel Syndrome
• Interventions: Drug: Mepivacaine, Combinations

• Registration Number: NCT06172400
• Lead Sponsor: Region Skane

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-15
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-26
• Study Start: 2024-01-09
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adrenaline	Mepivacaine, Combinations	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.
Touniquet	Mepivacaine, Combinations	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.

Primary Outcome Measures

Name	Time	Method
Procedural pain	Day 1	Visual analog scale 0 (no pain)-100 (worst possible pain)

Secondary Outcome Measures

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