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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04491656
Other study ID # EAMC IERB 2020 - 03
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date July 15, 2020

Study information

Verified date July 2020
Source East Avenue Medical Center, Philippines
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date July 15, 2020
Est. primary completion date July 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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

Locations

Country Name City State
Philippines East Avenue Medical Center; Department of Orthopedics Quezon City

Sponsors (1)

Lead Sponsor Collaborator
East Avenue Medical Center, Philippines

Country where clinical trial is conducted

Philippines, 

Outcome

Type Measure Description Time frame Safety issue
Other Complications Complications which may occur during the course of treatment and subsequent follow up of the patients which includes: wound complications, infection, stiffness, pain 24 weeks
Primary VRS Score Verbal Rating Scale
0 for no pain
1 for mild pain
2 for moderate pain
3 for severe pain
4 for very severe pain
24 weeks
Secondary Blood Loss Blood loss estimation using Gauze Visual Analogue Scale by Algadiem et.al. 24 weeks
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