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

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04992351
• Other study ID #: 11335
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: May 5, 2023

Study information

• Verified date: May 2024
• Source: University Hospital, Ioannina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 5, 2023
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Lower Limb Wound
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Greece	Plastic Surgery Department	Ioannina

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ioannina

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total operation time	the difference between skin incision and skin closure in minutes	through operation completion
Primary	operation theatre time	the difference between entry and exit of the patient from the operation theatre in minutes	through operation completion with exit from the operation theatre
Primary	Patient satisfaction	estimated by a 10-point visual analogue scale (1-10, 10 is the best outcome)	at 8 weeks
Primary	feasibility of the WALANT method	percentage of cases, which could not be completed under WALANT with conversion to the traditional method of anesthesia	through operation completion
Secondary	complications	number and type of complications in each group	at 8 weeks