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

Not Applicable

Recruiting

• Conditions: Safety Issues; Post Operative Pain; Local Anesthetic Complication
• Interventions: Procedure: Wide awake local anaesthesia no tourniquet technique

• Registration Number: NCT05864664
• Lead Sponsor: Ali Lari

Brief Summary

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2023-05-16
• Study First Posted: 2023-05-18
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-03
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anesthesia	Wide awake local anaesthesia no tourniquet technique	The surgery is performed in the standard fashion. The patient received general anesthesia The surgery is performed normally and the plate/screws are removed
WALANT procedure	Wide awake local anaesthesia no tourniquet technique	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

Primary Outcome Measures

Name	Time	Method
Evaluation of the patient's maximum pain intraoperatively at the surgical site	Intraoperative	Visual analogue pain scale - VAS
Blood loss	Intraoperative	Amount cc

Trial Locations

Locations (1)

AlRazi Orthopedic Hospital; 🇰🇼 Kuwait, Kuwait