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CompletedNCT04992351Updated May 8, 2024

Wide-awake Local Anesthesia and no Tourniquet (WALANT) in Plastic Surgery

An observational study in Upper Limb Wound, Lower Limb Wound and Anesthesia, Local, sponsored by University Hospital, Ioannina. Completed at 1 site in Greece. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by University Hospital, Ioannina · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
90
Ages
14 Years and older
Sex
All
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Study 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 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.

02

Conditions studied

  • Upper Limb Wound
  • Lower Limb Wound
  • Anesthesia, Local

Keywords

  • WALANT
  • plastic surgery
  • upper limb
  • lower limb
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In context

Lead sponsor

University Hospital, Ioannina is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients who undergo general plastic surgery operations in the upper or lower limb

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • upper or lower limb operation
  • indication for flap or skin grafting
  • operated by the principal investigator

Exclusion criteria

Exclusion Criteria:

  • other concomitant operations performed
  • known allergy to any of the ingredients of local anesthesia mixture
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
90 participants (actual)
Target follow-up
8 Weeks
Patient registry
Yes

Groups and cohorts

  • WALANT group

    WALANT was used exclusively as anesthesia method for the operation

    Procedure: WALANT

  • control

    tourniquet with regional or general anesthesia was used for the operation

    Procedure: WALANT

Interventions

  • ProcedureWALANT

    WALANT as anesthesia method for upper and lower limb palstic surgery operations

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What researchers measure

Primary outcomes

  1. total operation time

    the difference between skin incision and skin closure in minutes

    Time frame: through operation completion

  2. operation theatre time

    the difference between entry and exit of the patient from the operation theatre in minutes

    Time frame: through operation completion with exit from the operation theatre

  3. Patient satisfaction

    estimated by a 10-point visual analogue scale (1-10, 10 is the best outcome)

    Time frame: at 8 weeks

  4. feasibility of the WALANT method

    percentage of cases, which could not be completed under WALANT with conversion to the traditional method of anesthesia

    Time frame: through operation completion

Secondary outcomes

  1. complications

    number and type of complications in each group

    Time frame: at 8 weeks

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Study locations

1 site
  • Plastic Surgery Department
    Ioannina, Greece
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04992351
Lead sponsor
University Hospital, Ioannina
Responsible party
Konstantinos Seretis (Ass. Professor of Plastic Surgery, University Hospital, Ioannina) — Principal investigator
First posted
Aug 5, 2021
Start date
Jun 1, 2019
Primary completion
Oct 10, 2022
Completion
May 5, 2023
Last update
May 8, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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