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NCT05864664 Clinical Trial

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

Post Operative Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05864664
Other study ID # 2027
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date November 1, 2023

Study information
Verified date October 2023
Source Kuwait Institute for Medical Specialization
Contact Ali Lari, MD
Phone +96566428328
Email dr.alilari@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date November 1, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Kuwait AlRazi Orthopedic Hospital Kuwait

Sponsors (1)
Lead Sponsor Collaborator
Ali Lari

Country where clinical trial is conducted

Kuwait, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of the patient's maximum pain intraoperatively at the surgical site Visual analogue pain scale - VAS Intraoperative
Primary Blood loss Amount cc Intraoperative
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