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RecruitingNCT05864664Updated Oct 3, 2023

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

An interventional study of Wide awake local anaesthesia no tourniquet technique in Safety Issues, Post Operative Pain and Local Anesthetic Complication, sponsored by Ali Lari. Recruiting at 1 site in Kuwait. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-03.

Sponsored by Ali Lari · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 .

02

Conditions studied

  • Safety Issues
  • Post Operative Pain
  • Local Anesthetic Complication

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Allergy to local anesthesia
  • Psychiatric diagnosis including: affect disorders, uncooperative
  • Severe cardiovascular disease
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureWide 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

05

What researchers measure

Primary outcomes

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

    Visual analogue pain scale - VAS

    Time frame: Intraoperative

  2. Blood loss

    Amount cc

    Time frame: Intraoperative

06

Study locations

1 of 1 sites recruiting
  • AlRazi Orthopedic Hospital
    Kuwait, 00000, Kuwait
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05864664
Lead sponsor
Ali Lari
Responsible party
Ali Lari (Dr Ali Lari - MB BCh BAO, Kuwait Institute for Medical Specialization) — Sponsor-investigator
First posted
May 18, 2023
Start date
Apr 1, 2022
Primary completion
Nov 1, 2023 (estimated)
Completion
Nov 1, 2023 (estimated)
Last update
Oct 3, 2023

Study contacts

Ali Lari, MD
Contact
dr.alilari@gmail.com
+96566428328
Ali Jarragh, MD FRCS.C
principal investigator · Kuwait University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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