Safety and Efficacy of Wide Awake Local Anesthesia no Tourniquet Technique (WALANT) in Ankle Removal of Implant Surgery

Study Overview
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Brief Summary
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Safety and efficacy of wide awake local anesthesia no torniquet technique (WALANT) in ankle surgery. Studying risks and benefits from WALANT compared to general anesthesia . WALANT expected to decrease in intraoperative/post operative pain at the surgical site and decrease hospital time .

Official Title
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Comparing Removal of Ankle Implants/ Hardware Using the Wide-awake Local Anesthesia no Tourniquet (WALANT) Technique Versus General Anesthesia.

Conditions
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Safety Issues, Post Operative Pain, Local Anesthetic Complication

Intervention / Treatment
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* Procedure: Wide awake local anaesthesia no tourniquet technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: >18 Previous ORIF for: Unimalleolar fractures Bimalleolar fractures Trimalleolar fractures Exclusion Criteria: Allergy to local anesthesia Psychiatric diagnosis including: affect disorders, uncooperative Severe cardiovascular disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional, prospective, therapeutic, comparative, randomized controlled ?
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WALANT procedure<br>Patient awake with no form of sedation or analgesia A mixture of lidocaine, adrenaline, normal saline, bicarbonate is used to get 40-50ml solution Injection is performed around incision site - superficial to deep including periosteum Incision is performed in the normal fashion Plate and screws are removed and incision is closed | Procedure: Wide awake local anaesthesia no tourniquet technique<br>* Patient awake with no form of sedation or analgesia A mixture of lidocaine, adrenaline, normal saline, bicarbonate is used to get 40-50ml solution Injection is performed around incision site - superficial to deep including periosteum Incision is performed in the normal fashion Plate and screws are removed and incision is closed<br>|
| Active Comparator: General anesthesia<br>The surgery is performed in the standard fashion. The patient received general anesthesia The surgery is performed normally and the plate/screws are removed | Procedure: Wide awake local anaesthesia no tourniquet technique<br>* Patient awake with no form of sedation or analgesia A mixture of lidocaine, adrenaline, normal saline, bicarbonate is used to get 40-50ml solution Injection is performed around incision site - superficial to deep including periosteum Incision is performed in the normal fashion Plate and screws are removed and incision is closed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the patient's maximum pain intraoperatively at the surgical site | Visual analogue pain scale - VAS | Intraoperative | 
| Blood loss | Amount cc | Intraoperative |