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).
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
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 group | Role | What they receive |
|---|---|---|
| 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;). 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 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;). 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.
Perop VAS
VAS assessment at certain intervals (every 15 minutes, etc.), the highest value will be recorded
Measured: Perop
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.
- First posted11 Oct 2023
- Study start15 Jun 2022
- Primary completion10 Nov 2023
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, oguzhan albayrak, Istanbul University
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06077344
- Acronym / sponsor ID
- E-29624016-050.99-1682710
- Conditions
- Ankle Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wide - Awake Local Anesthesia No Tourniquet | Active comparator | 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 comparationWALANT 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;). |
| Applied Under Spinal Anesthesia | Active comparator | Procedure: Applied Under Spinal Anesthesia of Clinical Results of Surgical TreatmentApplied 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;). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ->18 years
- Isolated bimalleolar ankle fracture
- Isolated trimalleolar ankle fracture (posterior malleolar fracture will not be operative)
Key exclusion criteria (9 listed)
- < 18 years
- vasculitis
- Raynaud's disease
- Peripheral vascular disease
- peripheral neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WALANT in Ankle Fractures (Wide-Awake Local) Anesthesia No Tourniquet) and Applied Under Spinal Anesthesia Comparison of Clinical Results of Surgical Treatment;ANT Procedure comparationAlso: 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 | Procedure or surgery | Wide - Awake Local Anesthesia No Tourniquet |
| Applied Under Spinal Anesthesia of Clinical Results of Surgical TreatmentApplied Under Spinal Anesthesia of Clinical Results of Surgical Treatment | Procedure or surgery | Applied Under Spinal Anesthesia |
Primary outcome
Perop VAS
Time frame: Perop
VAS assessment at certain intervals (every 15 minutes, etc.), the highest value will be recorded
Postop Morphine Consume
Time frame: 24 hours
The amount of morphine used in the PCA device within 24 hours postop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Background: PubMed 34033408Fish 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/
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.