Pain in Carpal Tunnel Release Wide-awake Local Anesthesia With no Tourniquet vs Local Anesthesia With Tourniquet

NCT05747846 | Completed

• 1 other identifier: 5857
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare pain, satisfaction, and experience between patients who underwent Carpal Tunnel Release with wide-awake local anesthesia no tourniquet technique and local anesthesia with a tourniquet.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• Pain during surgery

  Visual analog scale. A numerical scale from 0 to 10 (a higher score means the worst outcome), where 0 indicates no pain, and 10 indicates the worst pain possible.

  Immediately after surgery

Study Arms (2)

wide-awake local anesthesia no tourniquet

ACTIVE COMPARATOR

Patients will be operated under local anesthesia without a tourniquet (WALANT technique)

Procedure: Carpal tunnel release, WALANT technique

Tourniquet

ACTIVE COMPARATOR

Patients will be operated under local anesthesia with the use of a tourniquet

Procedure: Carpal tunnel release using a tourniquet

Interventions

Carpal tunnel release, WALANT technique PROCEDURE

Patients will receive 20 ml of 1% lidocaine with 1:100,000 epinephrine (buffered 10:1 with 8.4% sodium bicarbonate). Thirty minutes before carpal tunnel release surgery, 10 mL will be injected subcutaneously, and 10 mL will be injected into the carpal tunnel. Patients will go under open carpal tunnel release without a tourniquet.

wide-awake local anesthesia no tourniquet

Carpal tunnel release using a tourniquet PROCEDURE

Patients will receive 20 ml of 1% lidocaine with 1:100,000 epinephrine (buffered 10:1 with 8.4% sodium bicarbonate). Thirty minutes before carpal tunnel release surgery, 10 mL will be injected subcutaneously, and 10 mL will be injected into the carpal tunnel. Patients will go under open carpal tunnel release using a hemostatic cuff. The hemostatic cuff will be insufflated at the level of the arm at a pressure of 100 mmHg higher than the patient's systolic pressure. The cuff will be removed once wound closure is complete.

Tourniquet

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Carpal tunnel syndrome with surgical resolution
• Surgical procedures takes less than 30 minutes

You may not qualify if:

• Lost follow-up

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano

Buenos Aires, 1198, Argentina

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

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

Study Officials

• Nicolas M Molho, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 28, 2023
• Study Start: December 15, 2020
• Primary Completion: August 7, 2023
• Study Completion: August 26, 2023
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)