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NCT06172400 Clinical Trial

Wide Awake Open Carpal Tunnel Release With or Without a Tourniquet

Carpal Tunnel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06172400
Other study ID # 2020-04670
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 9, 2024
Est. completion date December 31, 2025

Study information
Verified date December 2023
Source Region Skane
Contact Jesper Nordenskjöld, MD, PhD
Phone 0739706570
Email jesper.nordenskjold@skane.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 120
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Mepivacaine, Combinations
Using local anesthesia with adrenaline for intraoperative vasoconstriction instead of a tourniquet.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Region Skane

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