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

October 2, 2023 updated by: Ali Lari

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

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 .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Kuwait
      • Kuwait, Kuwait, 00000
        • Recruiting
        • Alrazi orthopedic hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
Active Comparator: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the patient's maximum pain intraoperatively at the surgical site
Time Frame: Intraoperative
Visual analogue pain scale - VAS
Intraoperative
Blood loss
Time Frame: Intraoperative
Amount cc
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ali Lari

Investigators

  • Principal Investigator: Ali Jarragh, MD FRCS.C, Kuwait University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

November 1, 2023

Study Registration Dates

First Submitted

August 16, 2022

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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