Safety IssuesNCT05864664
Safety and Efficacy of Wide Awake Local Anesthesia no Tourniquet Technique (WALANT) in Ankle Removal of Implant Surgery
A study testing Wide awake local anaesthesia no tourniquet technique in people with Safety Issues and Post Operative Pain, run by Ali Lari at 1 site in Kuwait.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Safety Issues, Post Operative Pain, Local Anesthetic Complication
- What is being tested?
- Wide awake local anaesthesia no tourniquet technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteKuwait
- Study dates
- 1 Apr 2022to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: >18
- Previous ORIF for:
- Unimalleolar fractures
- Bimalleolar fractures
- Trimalleolar fractures
Who cannot join
- Allergy to local anesthesia
- Psychiatric diagnosis including: affect disorders, uncooperative
- Severe cardiovascular disease
Trial locations and contacts
1 site in 1 country.
Kuwait1 site, 1 recruiting
- Recruiting
AlRazi Orthopedic Hospital
Kuwait City, 00000
Ali Lari, MB BCh BAO NUI RCSI, 66428328, dr.alilari@gmail.com
About this study
Official title: 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 .
- Being tested
- Wide awake local anaesthesia no tourniquet technique
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wide awake local anaesthesia no tourniquet techniqueProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Wide awake local anaesthesia no tourniquet technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the patient's maximum pain intraoperatively at the surgical site
Visual analogue pain scale - VAS
Measured: Intraoperative
Blood loss
Amount cc
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Apr 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, prospective, therapeutic, comparative, randomized controlled ?
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ali Lari
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Ali Lari, Kuwait Institute for Medical Specialization
- Investigators
- Ali Jarragh, MD FRCS.C, Principal investigator, Kuwait University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864664
- Sponsor's protocol ID
- 2027
- Status last verified
- Oct 2023
- First submitted
- 16 Aug 2022
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Removal of Ankle Implants/ Hardware Using the Wide-awake Local Anesthesia no Tourniquet (WALANT) Technique Versus General Anesthesia.
- ClinicalTrials.gov ID
- NCT05864664
- Acronym / sponsor ID
- 2027
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ali LariOther government
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional, prospective, therapeutic, comparative, randomized controlled ?
| Arm | Type | Receives |
|---|---|---|
| WALANT procedure | Experimental | Procedure: Wide awake local anaesthesia no tourniquet techniquePatient 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 | Active comparator | Procedure: Wide awake local anaesthesia no tourniquet techniqueThe surgery is performed in the standard fashion. The patient received general anesthesia The surgery is performed normally and the plate/screws are removed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: >18
- Previous ORIF for:
- Unimalleolar fractures
- Bimalleolar fractures
- Trimalleolar fractures
Key exclusion criteria (3 listed)
- Allergy to local anesthesia
- Psychiatric diagnosis including: affect disorders, uncooperative
- Severe cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wide awake local anaesthesia no tourniquet techniquePatient 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 or surgery | General anesthesia, WALANT procedure |
Primary outcome
Evaluation of the patient's maximum pain intraoperatively at the surgical site
Time frame: Intraoperative
Visual analogue pain scale - VAS
Blood loss
Time frame: Intraoperative
Amount cc
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Jarragh, MD FRCS.C principal investigator
Kuwait University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wide awake local anaesthesia no tourniquet technique in people with Safety Issues and Post Operative Pain, run by Ali Lari at 1 site in Kuwait.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Lari, MD (+96566428328, dr.alilari@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the patient's maximum pain intraoperatively at the surgical site (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.