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Completed

NCT Number: NCT04491656

Evaluating Clinical Outcomes for Determining the Optimal Delay to Skin Incision Under WALANT

Further studies are needed to establish the effects of WALANT in performing most common hand surgeries, in relation to its clinical outcomes and intraoperative blood loss. Therefore, this study aims to identify the best interval time to perform elective hand surgeries using WALANT technique, document clinical outcomes and identify potential complications

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Key information

Conditions

Hand Surgery Orthopedic Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East Avenue Medical Center; Department of Orthopedics

Quezon City, Philippines

About this study

To propose the optimal time delay from the injection to skin incision for most WALANT surgeries of the hand or wrist by analyzing not only intraoperative blood loss, but also postoperative pain scores and complication rates

To determine if there is a difference between performing the WALANT technique with a waiting interval of 7 minutes as compared to 30 minutes prior to incision in relation to blood loss, pain scores, and complications.

Initiate the use of WALANT technique and its application in practice of Orthopaedic Residents in East Avenue Medical Center

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • . Signed Consent Form
  • Elective Hand Surgeries
  • Minor Hand Surgeries
  • Adult Male/Female ages 18 and above
  • Multiply injured

Exclusion criteria

  • No Consent
  • Multiply injured patient
  • Traumatic Hand Injuries
  • Known allergic reaction to either Epinephrine or Lidocaine.
  • Known heart condition
  • Patients on anticoagulants
  • Patients diagnosed with bleeding disorders

Treatment and study plan

WALANT Technique

Other

A technique commonly used in hand surgeries where the combination of lidocaine and epinephrine is used for local blood control, thus performing the procedure without a tourniquet

Primary outcomes

  1. VRS Score

    Time frame: 24 weeks

    Verbal Rating Scale

    • 0 for no pain
    • 1 for mild pain
    • 2 for moderate pain
    • 3 for severe pain
    • 4 for very severe pain

Secondary outcomes

  1. Blood Loss

    Time frame: 24 weeks

    Blood loss estimation using Gauze Visual Analogue Scale by Algadiem et.al.

Other outcomes

  1. Complications

    Time frame: 24 weeks

    Complications which may occur during the course of treatment and subsequent follow up of the patients which includes: wound complications, infection, stiffness, pain

Sponsors and collaborators

Lead sponsor

East Avenue Medical Center, Philippines

Other Gov

Registry information

Official study title

Evaluating Clinical Outcomes for Determining the Optimal Delay to Skin Incision Under WALANT: a Prospective Series of 34 Patients From a Low Resource Tertiary Setting

Acronym: WALANT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 29, 2020
Registry last updated
Jul 29, 2020

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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