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

Ali Lari

Status: Enrolling

Conditions: Local Anesthetic Complication; Safety Issues; Post Operative Pain

Treatments: Procedure: Wide awake local anaesthesia no tourniquet technique

Study type: Interventional

Funder types: Other

Identifiers

NCT05864664

2027

Details and patient eligibility

About

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 .

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

WALANT procedure

Experimental group

Description:

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

Treatment:

Procedure: Wide awake local anaesthesia no tourniquet technique

General anesthesia

Active Comparator group

Description:

The surgery is performed in the standard fashion. The patient received general anesthesia The surgery is performed normally and the plate/screws are removed

Treatment:

Procedure: Wide awake local anaesthesia no tourniquet technique