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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Drug: Mepivacaine, Combinations

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jesper Nordenskjöld, MD, PhD; Phone Number: 0739706570; Email: jesper.nordenskjold@skane.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Touniquet; 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.	Drug: Mepivacaine, Combinations; Using local anesthesia with adrenaline for intraoperative vasoconstriction instead of a tourniquet.
Experimental: Adrenaline; 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.	Drug: Mepivacaine, Combinations; Using local anesthesia with adrenaline for intraoperative vasoconstriction instead of a tourniquet.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Region Skane

Study record dates

Study Major Dates

• Study Start (Estimated): January 9, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Mepivacaine
• Other Study ID Numbers: 2020-04670

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No