WALANT and Spinal Anesthesia Comparison of Clinical Result in Ankle Fractures

Recruiting

• Conditions: Ankle Fractures
• Interventions: Procedure: Applied Under Spinal Anesthesia of Clinical Results of Surgical Treatment; 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

• Registration Number: NCT06077344
• Lead Sponsor: Istanbul University

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.

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 Timeline

• Study Start: 2023-04-15
• Study First Submitted: 2023-04-15
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-08
• Study First Posted: 2023-10-11
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-25
• Primary Completion: 2024-12
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Applied Under Spinal Anesthesia	Applied Under Spinal Anesthesia of Clinical Results of Surgical Treatment	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;).
Wide - Awake Local Anesthesia No Tourniquet	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 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;).

Primary Outcome Measures

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

Trial Locations

Locations (1)

Istanbul University, Istanbul Faculty of Medicine, Department Orthopaedics and Traumatology; 🇹🇷 Istanbul, Çapa / Fatih, Turkey