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

NCT ID: NCT05747846

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2023-08-26

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.

Detailed Description

The surgical pathology of the hand has grown exponentially. In most cases, the resolution is performed in outpatients with short surgical times. Given the increased demand for this type of surgery, surgeons have sought different variables to reduce the costs and human resources. Thus, the wide-awake local anesthesia no tourniquet procedure (WALANT). It deals with the non-need for anesthetic monitoring and with the regional use of anesthesia with epinephrine.

Its use avoids placing a pneumatic cuff on the arm owing to the vasoconstrictive action of epinephrine. However, the drug takes 25-30 minutes to achieve the maximum hemostatic effect, and adverse effects, such as distal necrosis, have been reported.

Therefore, the technique of local anesthesia without epinephrine with a tourniquet (LA-T) is also used daily by hand surgeons.

The use of a tourniquet, a pneumatic cuff, for less than 20 minutes has been associated with the same or lower pain profiles than the wide-awake local anesthesia no tourniquet without running the risk of adverse effects of epinephrine.

The objective of this study is to compare and assess pain and patient experience after short-duration hand surgery using the WALANT and LA-T techniques. The investigators hypothesized that both types of procedures had a similar level of satisfaction.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

wide-awake local anesthesia no tourniquet

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

Group Type: ACTIVE_COMPARATOR

Carpal tunnel release, WALANT technique

Intervention Type: 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.

Tourniquet

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

Group Type: ACTIVE_COMPARATOR

Carpal tunnel release using a tourniquet

Intervention Type: 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.

Interventions

Carpal tunnel release, WALANT technique

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.

Intervention Type: PROCEDURE

Carpal tunnel release using a tourniquet

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Lost follow-up

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Italiano de Buenos Aires

OTHER

Sponsor Role: lead

Responsible Party

IGNACIO RELLAN

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicolas M Molho, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Italiano de Buenos Aires

Locations

Hospital Italiano

Buenos Aires, , Argentina

Countries

Argentina

Other Identifiers

5857

Identifier Type: -

Identifier Source: org_study_id