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Completed

NCT Number: NCT04992351

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

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.

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Key information

Conditions

Upper Limb Wound Anesthesia, Local Lower Limb Wound

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Plastic Surgery Department

Ioannina, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

WALANT

Procedure

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

Primary outcomes

  1. total operation time

    Time frame: through operation completion

    the difference between skin incision and skin closure in minutes

  2. 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

  3. Patient satisfaction

    Time frame: at 8 weeks

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

  4. 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

Secondary outcomes

  1. complications

    Time frame: at 8 weeks

    number and type of complications in each group

Sponsors and collaborators

Lead sponsor

University Hospital, Ioannina

Other

Registry information

Official study title

Wide-awake Local Anesthesia and no Tourniquet (WALANT) in Plastic Surgery: Indications, Clinical Applications and Outcomes

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Aug 5, 2021
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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