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

NCT05864664 | Unknown

• 1 other identifier: 2027
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 .

Conditions

Safety Issues; Post Operative Pain; Local Anesthetic Complication

Outcome Measures

Primary Outcomes (2)

• Evaluation of the patient's maximum pain intraoperatively at the surgical site

  Visual analogue pain scale - VAS

  Intraoperative

• Blood loss

  Amount cc

  Intraoperative

Study Arms (2)

WALANT procedure

EXPERIMENTAL

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

General anesthesia

ACTIVE COMPARATOR

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

Interventions

Wide awake local anaesthesia no tourniquet technique PROCEDURE

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

General anesthesia; WALANT procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: \>18
• Previous ORIF for:
• Unimalleolar fractures
• Bimalleolar fractures
• Trimalleolar fractures

You may not qualify if:

• Allergy to local anesthesia
• Psychiatric diagnosis including: affect disorders, uncooperative
• Severe cardiovascular disease

Sponsors & Collaborators

• Ali Lari: lead

Study Sites (1)

AlRazi Orthopedic Hospital

Kuwait City, 00000, Kuwait

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ali Jarragh, MD FRCS.C

  Kuwait University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Lari, MD

CONTACT

+96566428328; dr.alilari@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Ali Lari - MB BCh BAO

Model Details: Interventional, prospective, therapeutic, comparative, randomized controlled ?

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: May 18, 2023
• Study Start: April 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-10

Locations

KU (1)