WALANT and Spinal Anesthesia Comparison of Clinical Result in Ankle Fractures

Ankle Fractures Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06077344
• Other study ID #: E-29624016-050.99-1682710
• Status: Recruiting
• Start date: April 15, 2023
• Est. completion date: January 2025

Study information

• Verified date: October 2023
• Source: Istanbul University
• Contact: Oguzhan Albayrak
• Phone: 02124142000 - 31740
• Email: oguzhanorto[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone

Intervention

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
• Applied Under Spinal Anesthesia of Clinical Results of Surgical Treatment
Applied Under Spinal Anesthesia of Clinical Results of Surgical Treatment

Locations

Country	Name	City	State
Turkey	Istanbul University, Istanbul Faculty of Medicine, Department Orthopaedics and Traumatology	Istanbul	Çapa / Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & 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; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK570646/ — View Citation

Outcome

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

External Links

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