NCT06077344

Brief Summary

The application of the WALANT technique for foot and ankle surgery (joint fusion, implant removal and tendon repair, etc.) is limited. In our study, using the WALANT technique for ARIF in ankle fractures. The effect of this application on clinical outcomes will be prospectively evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
Last Updated

June 5, 2025

Status Verified

May 1, 2025

Enrollment Period

1.4 years

First QC Date

April 15, 2023

Last Update Submit

May 31, 2025

Conditions

Ankle Fractures

Outcome Measures

Primary Outcomes (2)

  • Perop VAS

    VAS assessment at certain intervals (every 15 minutes, etc.), the highest value will be recorded

    Perop

  • Postop Morphine Consume

    The amount of morphine used in the PCA device within 24 hours postop

    24 hours

Study Arms (2)

Wide - Awake Local Anesthesia No Tourniquet

ACTIVE COMPARATOR

WALANT solution used in our institution is prepared by mixing 20 ml of 2% lidocaine, with 0,4 ml 1:1000 (1 mg/ml) adrenaline in addition to 20 ml of 0,9% normal saline as described by Barros In the study, perop parameters to be checked are perop Visual Analogue Scale (VAS; at regular intervals (every 15 minutes, etc.) VAS evaluation, the highest value will be recorded), the time spent in the operating room Early postoperative parameters; Morphine consumption in PCA (in PCA device) the amount of morphine used in the postoperative 24 hours), the postoperative VAS (the postoperative 24th hour VAS) evaluation;).

Procedure: WALANT in Ankle Fractures (Wide-Awake Local) Anesthesia No Tourniquet) and Applied Under Spinal Anesthesia Comparison of Clinical Results of Surgical Treatment;ANT Procedure comparation

Applied Under Spinal Anesthesia

ACTIVE COMPARATOR

Applied Under Spinal Anesthesia Early postoperative parameters; Morphine consumption in PCA (in PCA device) the amount of morphine used in the postoperative 24 hours), the postoperative VAS (the postoperative 24th hour VAS) evaluation;).

Procedure: Applied Under Spinal Anesthesia of Clinical Results of Surgical Treatment

Interventions

WALANT in Ankle Fractures (Wide-Awake Local) Anesthesia No Tourniquet) and Applied Under Spinal Anesthesia Comparison of Clinical Results of Surgical Treatment;ANT Procedure comparationPROCEDURE

WALANT in Ankle Fractures (Wide-Awake Local) Anesthesia No Tourniquet) and Applied Under Spinal Anesthesia Comparison of Clinical Results of Surgical Treatment;ANT Procedure comparation

Also known as: jetokain/ Adrenalin 1 mg/1 ml Biosel Ampul/DROGSAN SODYUM BIKARBONAT 84 MG/ML IV.
Wide - Awake Local Anesthesia No Tourniquet
Applied Under Spinal Anesthesia of Clinical Results of Surgical TreatmentPROCEDURE

Applied Under Spinal Anesthesia of Clinical Results of Surgical Treatment

Applied Under Spinal Anesthesia

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years
  • Isolated bimalleolar ankle fracture
  • Isolated trimalleolar ankle fracture (posterior malleolar fracture will not be operative)

You may not qualify if:

  • \< 18 years
  • vasculitis
  • Raynaud's disease
  • Peripheral vascular disease
  • peripheral neuropathy
  • Lidocaine and epinephrine hypersensitivity
  • Grade \>1 open fractures
  • Maisonneuve, talus and posterior malleolus (requires fixation) fractures
  • multitrauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine, Department Orthopaedics and Traumatology

Istanbul, Çapa / Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (1)

  • Fish MJ, Bamberger HB. Wide-Awake Local Anesthesia No Tourniquet (WALANT) Hand Surgery. 2023 Apr 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK570646/

    PMID: 34033408BACKGROUND

Related Links

MeSH Terms

Conditions

Ankle Fractures

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

April 15, 2023

First Posted

October 11, 2023

Study Start

June 15, 2022

Primary Completion

November 10, 2023

Study Completion

December 10, 2024

Last Updated

June 5, 2025

Record last verified: 2025-05

Locations

TU(1)