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

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

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

Study Overview

• Status: Completed
• Conditions: Orthopedic Surgery; Hand Surgery
• Intervention / Treatment: Other: WALANT Technique

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 7 minutes group; surgeries performed with this group would wait 7 minutes after lidocaine+epinephrine injection prior to skin incision	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
ACTIVE_COMPARATOR: 30 minutes group; surgeries performed with this group would wait 30 minutes after lidocaine+epinephrine injection prior to skin incision	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Loss	Blood loss estimation using Gauze Visual Analogue Scale by Algadiem et.al.	24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: East Avenue Medical Center, Philippines
• Investigators: Study Chair: Mamer S. Rosario, MD, East Avenue Medical Center, Department of Orthopedics

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): July 15, 2020
• Study Completion (ACTUAL): July 15, 2020

Study Registration Dates

• First Submitted: July 23, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (ACTUAL): July 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: EAMC IERB 2020 - 03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient DATA will remain anonymous during the study and to be coded. Outcome measures for all participants will be documented
• IPD Sharing Time Frame: August 2020
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No