Carpal Tunnel Syndrome Clinical Trial
Official title:
Wide Awake Open Carpal Tunnel Release With or Without a Tourniquet: a Randomized Single-blinded Controlled Trial
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Region Skane |
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05067205 -
Minimal Invasive Carpal Tunnel Release With the Novel Device
|
N/A | |
Completed |
NCT03184688 -
Platelet Rich Plasma for Carpal Tunnel Syndrome
|
N/A | |
Completed |
NCT03582735 -
Preoperative Neuromobilization Exercises for Individuals With Carpal Tunnel Syndrome
|
N/A | |
Completed |
NCT05490420 -
Effects of Upper Extremity Manual Lymphatic Drainage on Symptom Severity, Hand Functions, Electrophysiological and Ultrasonographic Measurements in Carpal Tunnel Syndrome
|
N/A | |
Recruiting |
NCT05970692 -
Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale
|
||
Completed |
NCT04043780 -
Clinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome
|
N/A | |
Completed |
NCT03880812 -
Cost Information on Carpal Tunnel Syndrome Treatment Decisions
|
N/A | |
Completed |
NCT06464809 -
Treatment Intervention of Patients With Carpal Tunnel Syndrome (CTS)
|
N/A | |
Recruiting |
NCT05328180 -
aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE)
|
N/A | |
Recruiting |
NCT05372393 -
Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block
|
N/A | |
Recruiting |
NCT05503719 -
An Absorbable Suture Versus a Non-absorbable Suture in Carpal Tunnel Release, a Randomized Controlled Trial
|
N/A | |
Recruiting |
NCT05466162 -
Soft Tissue Massage Along With Mobilization Technique on Symptoms and Functional Status of Carpal Tunnel Syndrome
|
N/A | |
Completed |
NCT04060875 -
Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain
|
||
Not yet recruiting |
NCT06294821 -
4AP to Delay Carpal Tunnel Release (CTR)
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT04328805 -
Pain Reduction and Changes in Upper Limb Function Produced by an Ibuprofen Treatment in Carpal Tunnel Syndrome.
|
Phase 4 | |
Terminated |
NCT02791529 -
Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release
|
Phase 1 | |
Completed |
NCT02141035 -
Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome
|
Phase 2/Phase 3 | |
Completed |
NCT01887145 -
Comparison of Long-term Outcomes Following Endoscopic or Open Surgery for Carpal Tunnel Syndrome
|
N/A | |
Recruiting |
NCT01897272 -
Post-Operative Splinting After Short-Incision Carpal Tunnel Release: a Prospective Study
|
N/A | |
Completed |
NCT01394822 -
Neuromuscular Ultrasound for Focal Neuropathies
|
N/A |