Wide Awake Open Carpal Tunnel Release With or Without a Tourniquet

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06172400

Enrollment

120

Registered

2023-12-15

Start date

2024-01-09

Completion date

2025-12-31

Last updated

2023-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

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.

Interventions

DRUGMepivacaine, Combinations

Using local anesthesia with adrenaline for intraoperative vasoconstriction instead of a tourniquet.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Procedural pain	Day 1	Visual analog scale 0 (no pain)-100 (worst possible pain)

Secondary

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

Contacts

Primary ContactJesper Nordenskjöld, MD, PhD

jesper.nordenskjold@skane.se0739706570

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026