Upper Limb WoundNCT04992351
Wide-awake Local Anesthesia and no Tourniquet (WALANT) in Plastic Surgery
An observational study of Upper Limb Wound and Lower Limb Wound, run by University Hospital, Ioannina at 1 site in Greece.
Trial summary
Wide-awake local anesthesia no tourniquet (WALANT) was proposed and performed in hand operations. Aim of this study is to present the use of WALANT in operations performed on the upper and lower limbs, evaluate its efficacy in terms of feasibility, total operation time, total operating room time, bleeding, patient… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Upper Limb Wound, Lower Limb Wound, Anesthesia, Local
- What is being tested?
- WALANT
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jun 2019to 5 May 2023
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who undergo general plastic surgery operations in the upper or lower limb
Who may be able to join
- upper or lower limb operation
- indication for flap or skin grafting
- operated by the principal investigator
Who cannot join
- other concomitant operations performed
- known allergy to any of the ingredients of local anesthesia mixture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wide-awake Local Anesthesia and no Tourniquet (WALANT) in Plastic Surgery: Indications, Clinical Applications and Outcomes
Wide-awake local anesthesia no tourniquet (WALANT) was proposed and performed in hand operations.
Aim of this study is to present the use of WALANT in operations performed on the upper and lower limbs, evaluate its efficacy in terms of feasibility, total operation time, total operating room time, bleeding, patient discomfort and satisfaction and control for potential drawbacks. The hypothesis is that WALANT is a viable option in common operations performed by plastic surgeons on the upper and lower limbs.
Read the detailed description
Wide-awake local anesthesia no tourniquet (WALANT) was proposed and performed in hand operations. Little has been studied, regarding its indications and efficacy in general plastic surgery operations.
Aim of this study is to present the use of WALANT in operations performed on the upper and lower limbs, evaluate its efficacy in terms of feasibility, total operation time, total operating room time, bleeding, patient discomfort and satisfaction and control for potential drawbacks. The hypothesis is that WALANT is a viable option in common operations performed by plastic surgeons on the upper and lower limbs.
A prospective study will be conducted comparing the use of WALANT in operations performed on the upper and lower limbs to the traditional use of tourniquet with general or regional anesthesia.
- Conditions
- Upper Limb Wound, Lower Limb Wound, Anesthesia, Local
- Being tested
- WALANT
- Keywords
- WALANT, plastic surgery, upper limb, lower limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WALANTProcedure or surgery
WALANT as anesthesia method for upper and lower limb palstic surgery operations
| Study group | Role | What they receive |
|---|---|---|
| WALANT group | WALANT was used exclusively as anesthesia method for the operation Receives: Procedure: WALANT | |
| control | tourniquet with regional or general anesthesia was used for the operation Receives: Procedure: WALANT |
What is being measured
The primary outcome is the main question the study is designed to answer.
total operation time
the difference between skin incision and skin closure in minutes
Measured: through operation completion
operation theatre time
the difference between entry and exit of the patient from the operation theatre in minutes
Measured: through operation completion with exit from the operation theatre
Patient satisfaction
estimated by a 10-point visual analogue scale (1-10, 10 is the best outcome)
Measured: at 8 weeks
feasibility of the WALANT method
percentage of cases, which could not be completed under WALANT with conversion to the traditional method of anesthesia
Measured: through operation completion
Secondary outcomes (1)
complications
number and type of complications in each group
Measured: at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Jun 2019
- Primary completion10 Oct 2022
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb WoundStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- University Hospital, Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Seretis, University Hospital, Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992351
- Sponsor's protocol ID
- 11335
- Status last verified
- May 2024
- First submitted
- 13 Jul 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wide-awake Local Anesthesia and no Tourniquet (WALANT) in Plastic Surgery: Indications, Clinical Applications and Outcomes
- ClinicalTrials.gov ID
- NCT04992351
- Acronym / sponsor ID
- 11335
- Conditions
- Upper Limb Wound, Lower Limb Wound, Anesthesia, Local
- Keywords
- WALANT, plastic surgery, upper limb, lower limb
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, IoanninaUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 5 Aug 2021 (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.
Wide-awake local anesthesia no tourniquet (WALANT) was proposed and performed in hand operations.
Aim of this study is to present the use of WALANT in operations performed on the upper and lower limbs, evaluate its efficacy in terms of feasibility, total operation time, total operating room time, bleeding, patient discomfort and satisfaction and control for potential drawbacks. The hypothesis is that WALANT is a viable option in common operations performed by plastic surgeons on the upper and lower limbs.
Detailed description
Wide-awake local anesthesia no tourniquet (WALANT) was proposed and performed in hand operations. Little has been studied, regarding its indications and efficacy in general plastic surgery operations.
Aim of this study is to present the use of WALANT in operations performed on the upper and lower limbs, evaluate its efficacy in terms of feasibility, total operation time, total operating room time, bleeding, patient discomfort and satisfaction and control for potential drawbacks. The hypothesis is that WALANT is a viable option in common operations performed by plastic surgeons on the upper and lower limbs.
A prospective study will be conducted comparing the use of WALANT in operations performed on the upper and lower limbs to the traditional use of tourniquet with general or regional anesthesia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WALANT group | – | Procedure: WALANTWALANT was used exclusively as anesthesia method for the operation |
| control | – | Procedure: WALANTtourniquet with regional or general anesthesia was used for the operation |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who undergo general plastic surgery operations in the upper or lower limb
Key inclusion criteria (3 listed)
- upper or lower limb operation
- indication for flap or skin grafting
- operated by the principal investigator
Key exclusion criteria (2 listed)
- other concomitant operations performed
- known allergy to any of the ingredients of local anesthesia mixture
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 |
|---|---|---|
| WALANTWALANT as anesthesia method for upper and lower limb palstic surgery operations | Procedure or surgery | WALANT group, control |
Primary outcome
total operation time
Time frame: through operation completion
the difference between skin incision and skin closure in minutes
operation theatre time
Time frame: through operation completion with exit from the operation theatre
the difference between entry and exit of the patient from the operation theatre in minutes
Patient satisfaction
Time frame: at 8 weeks
estimated by a 10-point visual analogue scale (1-10, 10 is the best outcome)
feasibility of the WALANT method
Time frame: through operation completion
percentage of cases, which could not be completed under WALANT with conversion to the traditional method of anesthesia
1 secondary outcome
complications
Time frame: at 8 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 8 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Limb Wound and Lower Limb Wound, run by University Hospital, Ioannina at 1 site in Greece.
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 3 inclusion and 2 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 8 May 2024. 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 Greece. 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?
total operation time (time frame: through operation completion). The study lists 4 primary outcomes in all. 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 8 May 2024.