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

NCT04491656 | Completed

• 1 other identifier: EAMC IERB 2020 - 03
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Hand Surgery; Orthopedic Surgery

Outcome Measures

Primary Outcomes (1)

• VRS Score

  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

  24 weeks

Secondary Outcomes (1)

• Blood Loss

  24 weeks

Other Outcomes (1)

• Complications

  24 weeks

Study Arms (2)

7 minutes group

ACTIVE COMPARATOR

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

Other: WALANT Technique

30 minutes group

ACTIVE COMPARATOR

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

Other: WALANT Technique

Interventions

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

30 minutes group; 7 minutes group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• East Avenue Medical Center, Philippines: lead

Study Sites (1)

East Avenue Medical Center; Department of Orthopedics

Quezon City, Philippines

Location

Study Officials

• Mamer S. Rosario, MD

  East Avenue Medical Center, Department of Orthopedics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 29, 2020
• Study Start: January 1, 2019
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: August 2020

Locations

PH (1)