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Ankle FracturesNCT06077344

WALANT and Spinal Anesthesia Comparison of Clinical Result in Ankle Fractures

A study testing 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 and Applied Under Spinal Anesthesia of Clinical Results of Surgical Treatment in people with Ankle Fractures, run by Istanbul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Ankle Fractures
What is being tested?
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 and Applied Under Spinal Anesthesia of Clinical Results of Surgical Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jun 2022to 10 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • < 18 years
  • vasculitis
  • Raynaud's disease
  • Peripheral vascular disease
  • peripheral neuropathy
  • Lidocaine and epinephrine hypersensitivity
Show all 9Show fewer
  • Grade >1 open fractures
  • Maisonneuve, talus and posterior malleolus (requires fixation) fractures
  • multitrauma

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul University, Istanbul Faculty of Medicine, Department Orthopaedics and Traumatology

    Istanbul, Çapa / Fatih, 34093

Other trials in Turkey (Türkiye)

About this study

Official title: WALANT in Ankle Fractures (Wide-Awake Local) Anesthesia No Tourniquet) and Applied Under Spinal Anesthesia Comparison of Clinical Results of Surgical Treatment; Randomized Prospective Clinical Research

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.

Read the detailed description

In this prospective randomized controlled study, a 1-year follow-up of ankle fracture patients who underwent regional anesthesia and those who underwent WALANT will be performed. Planning is being made with a total of 50 patients from 25 patients each in the experimental and control groups. Patients over 18 years of age with isolated bimalleolar or trimalleolar (no fixation required for posterior malleolus fracture) ankle fracture will be included in the study at Istanbul University Istanbul Faculty of Medicine, Department of Orthopaedics and Traumatology. Parameters to be evaluated preop in the study; patient's age, gender, smoking, comorbidities if any, fracture mechanism (traffic accident, fall from height, sprain etc.), open/closed fracture (open fractures above grade 1 will not be included), fracture type (including isolated bimalleolar or trimalleolar fractures and AO classification of those involving medial and lateral malleolus), date of hospitalization, date of surgery, American Society of Anesthesiologists (ASA) and Amsterdam Preoperative Anxiety and Information Score (APAIS) scale, and type of anesthesia administered to the patient. The highest value will be recorded), time in the operating room (the time between the patient's entry into the operating room and the time between the completion of all procedures and exit from the operating room), operation time (the time between the start of the incision and the end of suturing), implant applied to the lateral malleolus (plate and screw +/- syndesmosis screw), implant applied to the medial malleolus (cannulated screw/ plate and screw/ zuggurtung), amount of bleeding (difference between the amount of fluid flushed and the amount of aspirate in the aspiration collection cup). The parameters to be looked at early postop are morphine consumption in PCA (the amount of morphine used in the PCA device in the postop 24 hours), postop VAS (postop 24th hour VAS assessment; it can also be looked at after PCA is removed), hospitalization (the time between hospitalization and discharge), cost (to be calculated on the invoices sent to the insurance company for each patient from hospital accounting; it can be done for the entire cost or only anesthesia costs can be compared). The parameters to be examined late postop will be; AOFAS (at 6 and 12 months), union status (the date when callus formation is seen in 3 of 4 cortices in AP and lateral radiographs in the patient's periodic controls will be accepted as the date of union), ipsilateral quadriceps diameter (measurement made from 1 or more than 1 thigh level at 6 and 12 months), contralateral quadriceps diameter (measurement made from 1 or more than 1 thigh level at 6 and 12 months).

Conditions
Ankle Fractures
Being tested
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 of Clinical Results of Surgical Treatment
Medical subject headings
Ankle Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 or surgery

    Also called jetokain/ Adrenalin 1 mg/1 ml Biosel Ampul/DROGSAN SODYUM BIKARBONAT 84 MG/ML IV.

    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 of Clinical Results of Surgical TreatmentProcedure or surgery

    Applied Under Spinal Anesthesia of Clinical Results of Surgical Treatment

Study groups in NCT06077344
Study groupRoleWhat they receive
Wide - Awake Local Anesthesia No TourniquetActive comparatorWALANT 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;).
Receives: 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 AnesthesiaActive comparatorApplied 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;).
Receives: Procedure: Applied Under Spinal Anesthesia of Clinical Results of Surgical Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perop VAS

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

    Measured: Perop

  2. Postop Morphine Consume

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

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2023
  2. Study start15 Jun 2022
  3. Primary completion10 Nov 2023
  4. Study completion10 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06077344
Sponsor's protocol ID
E-29624016-050.99-1682710
Status last verified
May 2025
First submitted
15 Apr 2023
Last updated
5 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fish MJ, Bamberger HB. Wide-Awake Local Anesthesia No Tourniquet (WALANT) Hand Surgery. 2023 Apr 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK570646/

    PubMed 34033408

Questions about this trial

What is this clinical trial studying?

A study testing 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 and Applied Under Spinal Anesthesia of Clinical Results of Surgical Treatment in people with Ankle Fractures, run by Istanbul University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perop VAS (time frame: Perop). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06077344, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.

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