Wide Awake Open Carpal Tunnel Release With or Without a Tourniquet

NCT06172400 | Unknown DMC

• 1 other identifier: 2020-04670
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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. 1.Do the tourniquet cause more procedural pain?
2. 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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• Procedural pain

  Visual analog scale 0 (no pain)-100 (worst possible pain)

  Day 1

Secondary Outcomes (8)

• Injection pain

  Day 1

• Procedure satisfaction

  Day 1

• Surgery time

  Day 1

• Use of diathermy/need to inflate or deflate tourniquet

  Day 1

• Adverse events

  2 weeks

Study Arms (2)

Touniquet

ACTIVE COMPARATOR

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

Adrenaline

EXPERIMENTAL

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

Interventions

Mepivacaine, Combinations DRUG

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

Adrenaline; Touniquet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Mepivacaine

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Jesper Nordenskjöld, MD, PhD

CONTACT

0739706570; jesper.nordenskjold@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: January 9, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share