Back to resultsSafety and Efficacy of Wide Awake Local Anesthesia no Tourniquet Technique (WALANT) in Ankle Removal of Implant Surgery
Primary Purpose
Safety Issues, Post Operative Pain, Local Anesthetic Complication
Status
Recruiting
Phase
Not Applicable
Locations
Kuwait
Study Type
Interventional
Intervention
Wide awake local anaesthesia no tourniquet technique
Sponsored by
About this trial
This is an interventional prevention trial for Safety Issues
Eligibility Criteria
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
Sites / Locations
- AlRazi Orthopedic HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
WALANT procedure
General anesthesia
Arm Description
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
The surgery is performed in the standard fashion. The patient received general anesthesia The surgery is performed normally and the plate/screws are removed
Outcomes
Primary Outcome Measures
Evaluation of the patient's maximum pain intraoperatively at the surgical site
Visual analogue pain scale - VAS
Blood loss
Amount cc
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05864664
Brief Title
Safety and Efficacy of Wide Awake Local Anesthesia no Tourniquet Technique (WALANT) in Ankle Removal of Implant Surgery
Official Title
Comparing Removal of Ankle Implants/ Hardware Using the Wide-awake Local Anesthesia no Tourniquet (WALANT) Technique Versus General Anesthesia.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ali Lari
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety Issues, Post Operative Pain, Local Anesthetic Complication
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Interventional, prospective, therapeutic, comparative, randomized controlled ?
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
WALANT procedure
Arm Type
Experimental
Arm Description
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
Arm Title
General anesthesia
Arm Type
Active Comparator
Arm Description
The surgery is performed in the standard fashion. The patient received general anesthesia The surgery is performed normally and the plate/screws are removed
Intervention Type
Procedure
Intervention Name(s)
Wide awake local anaesthesia no tourniquet technique
Intervention Description
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 Measure Information:
Title
Evaluation of the patient's maximum pain intraoperatively at the surgical site
Description
Visual analogue pain scale - VAS
Time Frame
Intraoperative
Title
Blood loss
Description
Amount cc
Time Frame
Intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Lari, MD
Phone
+96566428328
Email
dr.alilari@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Jarragh, MD FRCS.C
Organizational Affiliation
Kuwait University
Official's Role
Principal Investigator
Facility Information:
Facility Name
AlRazi Orthopedic Hospital
City
Kuwait
ZIP/Postal Code
00000
Country
Kuwait
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Lari, MB BCh BAO NUI RCSI
Phone
66428328
Email
dr.alilari@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Safety and Efficacy of Wide Awake Local Anesthesia no Tourniquet Technique (WALANT) in Ankle Removal of Implant Surgery
We'll reach out to this number within 24 hrs