Eye DiseasesNCT02459782
Ultrasound Guided Peribulbar Anaesthesia - A Novel Dual Quadrant Injection Technique
A study testing Ultrasound guided Dual Quadrant Peribulbar Anaesthesia in people with Eye Diseases, run by Sunnybrook Health Sciences Centre.
Trial summary
Peribulbar anaesthesia for ocular surgery depends on the spread of local anaesthetic throught the orbit to be successful and has a relatively high failure rate. This study will examine a novel ultrasound guided approach to peribulbar anaesthesia which should extend the depostion of local anaesthetic by using a dual… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Eye Diseases
- What is being tested?
- Ultrasound guided Dual Quadrant Peribulbar Anaesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Aug 2012
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA score less than III and ability to provide a written informed consent
- 22 patients presenting for opthalmic surgery
Who cannot join
- Coagulation disorder or anticoagulated with INR > 1.5
- Platelet count < 75 X 10*9/L
- Significant Myopia (axial length > 28mm)
- Patients unable to lie supine for 2 hours
- Patients with recent gas or silicone injections in/around the eye
About this study
Official title: Ultrasound Guided Peribulbar Anaesthesia: a Real-time Ultrasound Guided Technique With a Novel Dual Quadrant Injection
Peribulbar anaesthesia for ocular surgery depends on the spread of local anaesthetic throught the orbit to be successful and has a relatively high failure rate. This study will examine a novel ultrasound guided approach to peribulbar anaesthesia which should extend the depostion of local anaesthetic by using a dual quadrant injection technique. The study will assess the feasibility of this technique, how successful it is and whether any obvious safety issues arise with its use.
Read the detailed description
Peribulbar anesthesia is widely used for anterior and posterior chamber ophthalmic procedures. It is a blind technique which is traditionally carried out by inserting a needle in the infero-lateral aspect of the orbit below the globe and injecting a volume of 8 - 12 mL of local anesthetic in the periorbital space. The goal of this inejction is to achieve akinesia and anesthesia of the eye sufficient for surgery. The technique has a relatively high failure rate of up to 30%. A failure or insufficient block requires a second or rarely a third peribulbar injection to achieve success. Ultrasound can be used to guide needles in the human body and has been successfully used in many anatomic locations for anaesthesia. This study will assess whether ultrasound can guide the block needle in ophthalmic anesthesia to deliver local anesthetic via a single entry into two discrete locations within the periorbital space - the first in the infero-lateral quadrant and the second in the infero-medial quadrant. If this can be done the investigators may achieve a higher success rate for this block with a lower volume potentially improving the quality of the block and its safety.
- Conditions
- Eye Diseases
- Being tested
- Ultrasound guided Dual Quadrant Peribulbar Anaesthesia
- Keywords
- Ultrasound guided peribulbar anesthesia
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided Dual Quadrant Peribulbar AnaesthesiaProcedure or surgery
Landmark Guided single injection vs Ultrasound guided dual quadrant injection
| Study group | Role | What they receive |
|---|---|---|
| US Guided Dual Quadrant Peribulbar block | Other | Ultrasound guided Dual Quadrant Peribulbar Anaesthesia Receives: Procedure: Ultrasound guided Dual Quadrant Peribulbar Anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block Success
Block will be deemed a failure if a supplementary block is required for the operative procedure
Measured: 10 minutes post intervention
Secondary outcomes (5)
Block Quality (standardized Ocular Scoring System for akinesia and anaesthesia)
Block will be assessed according to a standardized Ocular Scoring System for akinesia and anaesthesia at 5 minutes and 10 minutes post block. This is a composite measure
Measured: 5 and 10 minutes
Block Volume
Total volume of local anaesthetic will be recorded. Volume for each part of the dual injection technique will also be recorded. This is a composite measure.
Measured: 1 minute
Duration of Procedure
The duration of the entire procedure will be recorded
Measured: 1 to 10 minutes
Complications
Any complications during the procedure or in follow up clinical visits will be recorded
Measured: 6 Weeks
Image Visualization
Operator's ability to see the needle in both the infero-lateral and infero-medial injection will be recorded. Ability to see perineural, retrobulbar and medial rectus spread of local anaesthetic will be recorded. This is a composite qualitative measure.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startJan 2012
- Primary completionMar 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul G McHardy, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459782
- Sponsor's protocol ID
- 424-2011
- Status last verified
- May 2015
- First submitted
- 20 Mar 2015
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Peribulbar Anaesthesia: a Real-time Ultrasound Guided Technique With a Novel Dual Quadrant Injection
- ClinicalTrials.gov ID
- NCT02459782
- Acronym / sponsor ID
- 424-2011
- Conditions
- Eye Diseases
- Keywords
- Ultrasound guided peribulbar anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 2 Jun 2015 (estimated)
- 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.
Peribulbar anaesthesia for ocular surgery depends on the spread of local anaesthetic throught the orbit to be successful and has a relatively high failure rate. This study will examine a novel ultrasound guided approach to peribulbar anaesthesia which should extend the depostion of local anaesthetic by using a dual quadrant injection technique. The study will assess the feasibility of this technique, how successful it is and whether any obvious safety issues arise with its use.
Detailed description
Peribulbar anesthesia is widely used for anterior and posterior chamber ophthalmic procedures. It is a blind technique which is traditionally carried out by inserting a needle in the infero-lateral aspect of the orbit below the globe and injecting a volume of 8 - 12 mL of local anesthetic in the periorbital space. The goal of this inejction is to achieve akinesia and anesthesia of the eye sufficient for surgery. The technique has a relatively high failure rate of up to 30%. A failure or insufficient block requires a second or rarely a third peribulbar injection to achieve success. Ultrasound can be used to guide needles in the human body and has been successfully used in many anatomic locations for anaesthesia. This study will assess whether ultrasound can guide the block needle in ophthalmic anesthesia to deliver local anesthetic via a single entry into two discrete locations within the periorbital space - the first in the infero-lateral quadrant and the second in the infero-medial quadrant. If this can be done the investigators may achieve a higher success rate for this block with a lower volume potentially improving the quality of the block and its safety.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| US Guided Dual Quadrant Peribulbar block | Other | Procedure: Ultrasound guided Dual Quadrant Peribulbar AnaesthesiaUltrasound guided Dual Quadrant Peribulbar Anaesthesia |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA score less than III and ability to provide a written informed consent
- 22 patients presenting for opthalmic surgery
Key exclusion criteria (5 listed)
- Coagulation disorder or anticoagulated with INR > 1.5
- Platelet count < 75 X 10*9/L
- Significant Myopia (axial length > 28mm)
- Patients unable to lie supine for 2 hours
- Patients with recent gas or silicone injections in/around the eye
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 |
|---|---|---|
| Ultrasound guided Dual Quadrant Peribulbar AnaesthesiaLandmark Guided single injection vs Ultrasound guided dual quadrant injection | Procedure or surgery | US Guided Dual Quadrant Peribulbar block |
Primary outcome
Block Success
Time frame: 10 minutes post intervention
Block will be deemed a failure if a supplementary block is required for the operative procedure
5 secondary outcomes
Block Quality (standardized Ocular Scoring System for akinesia and anaesthesia)
Time frame: 5 and 10 minutes
Block Volume
Time frame: 1 minute
Duration of Procedure
Time frame: 1 to 10 minutes
Complications
Time frame: 6 Weeks
Image Visualization
Time frame: 1 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
Related trials for Eye Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
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.
Paul G McHardy, MD principal investigator
Sunnybrook Health Sciences Centre
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided Dual Quadrant Peribulbar Anaesthesia in people with Eye Diseases, run by Sunnybrook Health Sciences Centre.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Block Success (time frame: 10 minutes post intervention). 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 2 Jun 2015.