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

NCT ID: NCT04491656

Last Updated: 2020-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-07-15

Brief Summary

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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

Detailed Description

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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

Conditions

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Hand Surgery Orthopedic Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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7 minutes group

surgeries performed with this group would wait 7 minutes after lidocaine+epinephrine injection prior to skin incision

Group Type ACTIVE_COMPARATOR

WALANT Technique

Intervention Type 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

30 minutes group

surgeries performed with this group would wait 30 minutes after lidocaine+epinephrine injection prior to skin incision

Group Type ACTIVE_COMPARATOR

WALANT Technique

Intervention Type 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

Interventions

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WALANT Technique

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. . Signed Consent Form
2. Elective Hand Surgeries
3. Minor Hand Surgeries
4. Adult Male/Female ages 18 and above
5. Multiply injured

Exclusion Criteria

1. No Consent
2. Multiply injured patient
3. Traumatic Hand Injuries
4. Known allergic reaction to either Epinephrine or Lidocaine.
5. Known heart condition
6. Patients on anticoagulants
7. Patients diagnosed with bleeding disorders
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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East Avenue Medical Center, Philippines

OTHER_GOV

Sponsor Role lead

Responsible Party

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Alvin A. Hernandez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mamer S. Rosario, MD

Role: STUDY_CHAIR

East Avenue Medical Center, Department of Orthopedics

Locations

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East Avenue Medical Center; Department of Orthopedics

Quezon City, , Philippines

Site Status

Countries

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Philippines

Other Identifiers

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EAMC IERB 2020 - 03

Identifier Type: -

Identifier Source: org_study_id

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