Retinal and Infra-ocular PathologyNCT02151968
Traditional Blind Versus Ultrasound-guided Peribulbar Blockade
A study testing Local Anaesthetic Injection and Ultrasound-Guidance in people with Retinal and Infra-ocular Pathology, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Eye surgeries are traditionally performed under local anaesthesia with a peribulbar block. This is a blind technique where local anaesthetic is injected into the back of the eye to make the eye numb and motionless for surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal and Infra-ocular Pathology
- What is being tested?
- Local Anaesthetic Injection and Ultrasound-Guidance
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2019to 15 Feb 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing vitrectomy surgery
Who cannot join
- Lack of informed consent
- Coagulopathic disorder, anticoagulated with INR (international normalized ratio) > 1.5 or platelet count less than 75 x 10^9/L
- Pathological myopia. Inability of patient to lie down for 2 hours for the operation -Local infection at site of needle entry
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Paul McHardy, MD, 416-480-6100 ext. pg x 6626, paul.mchardy@sunnybrook.ca
Paul McHardy, MD
About this study
Eye surgeries are traditionally performed under local anaesthesia with a peribulbar block. This is a blind technique where local anaesthetic is injected into the back of the eye to make the eye numb and motionless for surgery. This is a blind injection and can be associated with complications such as bleeding, rupture of eye globe, blindness, increasing the pressure of the eye etc. It also has a high failure rate resulting in need for additional injections, further exposing the patient to possible complications. The investigators propose to perform the peribulbar block with ultrasound to guide the block needle placement and injection. The investigators hypothesize that ultrasound guided peribulbar blocks would have higher success rate (less need for additional injections) and that the total amount of local anaesthetics used would be decreased.
- Conditions
- Retinal and Infra-ocular Pathology
- Being tested
- Local Anaesthetic Injection, Ultrasound-Guidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Anaesthetic InjectionProcedure or surgery
Local anaesthetic is injected into the eye.
Ultrasound-GuidanceProcedure or surgery
Also called Ultrasound Machine
Device: Ultrasound Machine
Peribulbar block local anaesthetic is injected into the eye with ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Traditional blind peribulbar block | Active comparator | Not described Receives: Procedure: Local Anaesthetic Injection |
| Ultrasound-guided peribulbar block | Experimental | Not described Receives: Procedure: Local Anaesthetic Injection; Procedure: Ultrasound-Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of peribulbar block
Ocular Anaesthetic Scoring System (OASS) score of less than 10 will be considered inadequate for surgery and a block failure.
Measured: 10 minutes after block performed
Secondary outcomes (3)
Quality of the block
Quality of the block based on the OASS score will be classified as poor (0-3), average (4-9) and good (10-14).
Measured: 5 and 10 min after block performed
Incidence of Supplemental Peribulbar injections
To determine incidence of additional peribulbar injections after failure of original block as determined preoperatively by the anaesthetist or intraoperatively by the surgeon.
Measured: Operative day 0
Volume of Total Local Anaesthetic Used
The total volume of local anaesthetic used for peribulbar block preoperatively and intraoperatively.
Measured: Operative day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study start1 Jul 2019 (estimated)
- Primary completion30 Nov 2019 (estimated)
- Study completion15 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal and Infra-ocular PathologyStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Paul McHardy, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151968
- Sponsor's protocol ID
- USG123
- Status last verified
- May 2018
- First submitted
- 20 May 2014
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Blind Versus Ultrasound-guided Peribulbar Blockade
- ClinicalTrials.gov ID
- NCT02151968
- Acronym / sponsor ID
- USG123
- Conditions
- Retinal and Infra-ocular Pathology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 15 Feb 2020 (estimated)
- First posted
- 2 Jun 2014 (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.
Eye surgeries are traditionally performed under local anaesthesia with a peribulbar block. This is a blind technique where local anaesthetic is injected into the back of the eye to make the eye numb and motionless for surgery. This is a blind injection and can be associated with complications such as bleeding, rupture of eye globe, blindness, increasing the pressure of the eye etc. It also has a high failure rate resulting in need for additional injections, further exposing the patient to possible complications. The investigators propose to perform the peribulbar block with ultrasound to guide the block needle placement and injection. The investigators hypothesize that ultrasound guided peribulbar blocks would have higher success rate (less need for additional injections) and that the total amount of local anaesthetics used would be decreased.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional blind peribulbar block | Active comparator | Procedure: Local Anaesthetic Injection |
| Ultrasound-guided peribulbar block | Experimental | Procedure: Local Anaesthetic Injection, Procedure: Ultrasound-Guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing vitrectomy surgery
Key exclusion criteria (3 listed)
- Lack of informed consent
- Coagulopathic disorder, anticoagulated with INR (international normalized ratio) > 1.5 or platelet count less than 75 x 10^9/L
- Pathological myopia. Inability of patient to lie down for 2 hours for the operation -Local infection at site of needle entry
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 |
|---|---|---|
| Local Anaesthetic InjectionLocal anaesthetic is injected into the eye. | Procedure or surgery | Traditional blind peribulbar block, Ultrasound-guided peribulbar block |
| Ultrasound-GuidanceAlso: Ultrasound MachineDevice: Ultrasound Machine Peribulbar block local anaesthetic is injected into the eye with ultrasound guidance. | Procedure or surgery | Ultrasound-guided peribulbar block |
Primary outcome
Failure of peribulbar block
Time frame: 10 minutes after block performed
Ocular Anaesthetic Scoring System (OASS) score of less than 10 will be considered inadequate for surgery and a block failure.
3 secondary outcomes
Quality of the block
Time frame: 5 and 10 min after block performed
Incidence of Supplemental Peribulbar injections
Time frame: Operative day 0
Volume of Total Local Anaesthetic Used
Time frame: Operative day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
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.
Sunnybrook Health Sciences Centre
Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Anaesthetic Injection and Ultrasound-Guidance in people with Retinal and Infra-ocular Pathology, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 1 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 7 May 2018. 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 Canada. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of peribulbar block (time frame: 10 minutes after block performed). 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 7 May 2018.