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

Orthopedic Surgery Clinical Trial

— WALANT  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04491656
• Other study ID #: EAMC IERB 2020 - 03
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hand Surgery
• Orthopedic Surgery
• Surgical Wound

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