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NCT Number: NCT05747846

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

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Italiano

Buenos Aires, 1198, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Lost follow-up

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain during surgery

    Time frame: Immediately after 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.

Sponsors and collaborators

Lead sponsor

Hospital Italiano de Buenos Aires

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2023
Registry last updated
Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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