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

Not Applicable

Completed

• Conditions: Orthopedic Surgery; Hand Surgery
• Interventions: Other: WALANT Technique

• Registration Number: NCT04491656
• Lead Sponsor: East Avenue Medical Center, Philippines

Brief 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

Detailed 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

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2020-07
• Primary Completion: 2020-07-15
• Study Completion: 2020-07-15
• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-27
• Study First Posted: 2020-07-29
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
7 minutes group	WALANT Technique	surgeries performed with this group would wait 7 minutes after lidocaine+epinephrine injection prior to skin incision
30 minutes group	WALANT Technique	surgeries performed with this group would wait 30 minutes after lidocaine+epinephrine injection prior to skin incision

Primary Outcome Measures

Name	Time	Method
VRS Score	24 weeks	Verbal Rating Scale; 1. 0 for no pain; 2. 1 for mild pain; 3. 2 for moderate pain; 4. 3 for severe pain; 5. 4 for very severe pain

Secondary Outcome Measures

Name	Time	Method
Blood Loss	24 weeks	Blood loss estimation using Gauze Visual Analogue Scale by Algadiem et.al.

Trial Locations

Locations (1)

East Avenue Medical Center; Department of Orthopedics; 🇵🇭 Quezon City, Philippines