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

NCT ID: NCT05864664

Last Updated: 2023-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-11-01

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 .

Detailed Description

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Conditions

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Safety Issues Post Operative Pain Local Anesthetic Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Interventional, prospective, therapeutic, comparative, randomized controlled ?
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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WALANT 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

Group Type EXPERIMENTAL

Wide awake local anaesthesia no tourniquet technique

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Wide awake local anaesthesia no tourniquet technique

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ali Lari

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ali Lari

Dr Ali Lari - MB BCh BAO

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ali Jarragh, MD FRCS.C

Role: PRINCIPAL_INVESTIGATOR

Kuwait University

Locations

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AlRazi Orthopedic Hospital

Kuwait City, , Kuwait

Site Status RECRUITING

Countries

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Kuwait

Central Contacts

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Ali Lari, MD

Role: CONTACT

+96566428328

Facility Contacts

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Ali Lari, MB BCh BAO NUI RCSI

Role: primary

Other Identifiers

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2027

Identifier Type: -

Identifier Source: org_study_id

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