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

NCT ID: NCT04992351

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2023-05-05

Brief Summary

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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

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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

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Upper Limb Wound Lower Limb Wound Anesthesia, Local

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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WALANT group

WALANT was used exclusively as anesthesia method for the operation

WALANT

Intervention Type PROCEDURE

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

control

tourniquet with regional or general anesthesia was used for the operation

WALANT

Intervention Type PROCEDURE

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

Interventions

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WALANT

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ioannina

OTHER

Sponsor Role lead

Responsible Party

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Konstantinos Seretis

Ass. Professor of Plastic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Plastic Surgery Department

Ioannina, , Greece

Site Status

Countries

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Greece

Other Identifiers

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11335

Identifier Type: -

Identifier Source: org_study_id

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