Hand SurgeryWALANTNCT04491656
Evaluating Clinical Outcomes for Determining the Optimal Delay to Skin Incision Under WALANT
A study testing WALANT Technique in people with Hand Surgery and Orthopedic Surgery, run by East Avenue Medical Center, Philippines at 1 site in Philippines.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hand Surgery, Orthopedic Surgery
- What is being tested?
- WALANT Technique
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePhilippines
- Study dates
- 1 Jan 2019to 15 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- . Signed Consent Form
- Elective Hand Surgeries
- Minor Hand Surgeries
- Adult Male/Female ages 18 and above
- Multiply injured
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Philippines1 site
East Avenue Medical Center; Department of Orthopedics
Quezon City
About this study
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
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
Read the 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
- Conditions
- Hand Surgery, Orthopedic Surgery
- Being tested
- WALANT Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WALANT TechniqueOther
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
| Study group | Role | What they receive |
|---|---|---|
| 7 minutes group | Active comparator | surgeries performed with this group would wait 7 minutes after lidocaine+epinephrine injection prior to skin incision Receives: 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 Receives: Other: WALANT Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks
Secondary outcomes (1)
Blood Loss
Blood loss estimation using Gauze Visual Analogue Scale by Algadiem et.al.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start1 Jan 2019
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Avenue Medical Center, Philippines
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alvin A. Hernandez, East Avenue Medical Center, Philippines
- Investigators
- Mamer S. Rosario, MD, Study chair, East Avenue Medical Center, Department of Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491656
- Sponsor's protocol ID
- EAMC IERB 2020 - 03
- Acronym
- WALANT
- Status last verified
- Jul 2020
- First submitted
- 23 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient DATA will remain anonymous during the study and to be coded. Outcome measures for all participants will be documented
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04491656
- Acronym / sponsor ID
- WALANT / EAMC IERB 2020 - 03
- Conditions
- Hand Surgery, Orthopedic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- East Avenue Medical Center, PhilippinesOther government
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7 minutes group | Active comparator | Other: WALANT Techniquesurgeries performed with this group would wait 7 minutes after lidocaine+epinephrine injection prior to skin incision |
| 30 minutes group | Active comparator | Other: WALANT Techniquesurgeries performed with this group would wait 30 minutes after lidocaine+epinephrine injection prior to skin incision |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- . Signed Consent Form
- Elective Hand Surgeries
- Minor Hand Surgeries
- Adult Male/Female ages 18 and above
- Multiply injured
Key exclusion criteria (7 listed)
- No Consent
- Multiply injured patient
- Traumatic Hand Injuries
- Known allergic reaction to either Epinephrine or Lidocaine.
- Known heart condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WALANT TechniqueA 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 | Other | 30 minutes group, 7 minutes group |
Primary outcome
VRS Score
Time frame: 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
1 secondary outcome
Blood Loss
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: Yes. Patient DATA will remain anonymous during the study and to be coded. Outcome measures for all participants will be documented
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mamer S. Rosario, MD study chair
East Avenue Medical Center, Department of Orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WALANT Technique in people with Hand Surgery and Orthopedic Surgery, run by East Avenue Medical Center, Philippines at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VRS Score (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020; AzTrials last refreshed its copy on 3 Nov 2026.