WALANT and Spinal Anesthesia Comparison of Clinical Result in Ankle Fractures

October 24, 2023 updated by: oguzhan albayrak, Istanbul University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Çapa / Fatih
      • Istanbul, Çapa / Fatih, Turkey, 34093
        • Recruiting
        • Istanbul University, Istanbul Faculty of Medicine, Department Orthopaedics and Traumatology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients over 18 years of age with isolated bimalleolar or trimalleolar ankle fractures (no fixation required for posterior malleolus fracture) at Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology will be included in the study.

Description

Inclusion Criteria:

->18 years

  • Isolated bimalleolar ankle fracture
  • Isolated trimalleolar ankle fracture (posterior malleolar fracture will not be operative)

Exclusion Criteria:

  • < 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Wide - Awake Local Anesthesia No Tourniquet

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
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
Other Names:
  • jetokain/ Adrenalin 1 mg/1 ml Biosel Ampul/DROGSAN SODYUM BIKARBONAT 84 MG/ML IV.
Applied Under Spinal Anesthesia

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
Applied Under Spinal Anesthesia of Clinical Results of Surgical Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perop VAS
Time Frame: Perop
VAS assessment at certain intervals (every 15 minutes, etc.), the highest value will be recorded
Perop
Postop Morphine Consume
Time Frame: 24 hours
The amount of morphine used in the PCA device within 24 hours postop
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

April 15, 2023

First Submitted That Met QC Criteria

October 8, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-29624016-050.99-1682710

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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