Ophthalmic SurgeryNCT01258959
Anaesthesia for Ophthalmic Surgery: How "Retro" is the Peribulbar Block?
An observational study of Ophthalmic Surgery and Parabulbar Block, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Ophthalmic surgery on the posterior section of the eye can either be performed under general anaesthesia or under local aneasthesia. The local anaesthesia is performed by injecting local anaesthetics behind the eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ophthalmic Surgery, Parabulbar Block
- What is being tested?
- Ultrasound detection of local anesthetics spread
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Jun 2011
- Phase
- Observational
- 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
Study population: 100 consecutive patients (men and women) of at least 18 years of age undergoing an ophthalmic procedure on the posterior section of the eye under local anaesthesia, i.e. with a peribulbar block.
Who may be able to join
- -informed consent
Who cannot join
- coagulation disorder
- INR over 1.5 and/or a platelet count less than 75 X 109/L,
- pathological myopia,
- inability of the patient to lie down for the operation for more than 2 hours
- lack of informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Ophthalmic surgery on the posterior section of the eye can either be performed under general anaesthesia or under local aneasthesia. The local anaesthesia is performed by injecting local anaesthetics behind the eye. There are two techniques: Either the needle is placed into the muscle cone formed by the four recti muscles - this is called intraconal or retrobulbar block, or the needle is placed outside of the muscle cone - this would be called extraconal or peribulbar. In our hospital the investigators usually perform the peribulbar block since it is easier to perform and has a smaller risk to injure the eye. The investigators however realize that the parabulbar block is sometimes very efficient and sometimes not, thus requiring a second or third injection. Now investigators are able to visualize where the local anaesthetics spreads with the help of ultrasound imaging. The aim of the study is to observe and to describe the incidence of intraconal spread of local anaesthetics when a peribulbar block is performed.
- Conditions
- Ophthalmic Surgery, Parabulbar Block
- Being tested
- Ultrasound detection of local anesthetics spread
- Keywords
- Ultrasound, retrobulbar, parabulbar, ophthalmic surgery.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound detection of local anesthetics spreadProcedure or surgery
During the parabulbar injection the ultrasound operator experienced in ultrasound guided retrobulbar block will assess whether there is spread of local anaesthetic in the central cone just behind the sclera (yes or no). The anaesthesist performing the block will be blinded to the ultrasound visualized spread of local anaesthetic.
| Study group | Role | What they receive |
|---|---|---|
| Ophthalmic surgery patients | Patients (men and women) of at least 18 years of age undergoing an ophthalmic procedure on the posterior section of the eye under local anaesthesia, i.e. with a peribulbar block. Inclusion and exclusion criteria for the study are the same as for the peribulbar anaesthesia. Receives: Procedure: Ultrasound detection of local anesthetics spread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of detectable retrobulbar spread of local anaesthetics during peribulbar injection.
The outcome measure is the description of the spread of local anesthetics during the injection of the drug via the parabulbar needle.
Measured: At start (During peribulbar injection)
Secondary outcomes (1)
Assessment of block quality
Assessment of the block quality by ophthalmic surgeon just before surgery starts and at least 20 minutes after the block: complete akinesia and anaesthesia or partial akinesia/anaesthesia.
Measured: 20 Minutes after block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ophthalmic SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258959
- Sponsor's protocol ID
- Retro-Parabulbar
- Status last verified
- Dec 2010
- First submitted
- 8 Dec 2010
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Luyet C, Eichenberger U, Moriggl B, Remonda L, Greif R. Real-time visualization of ultrasound-guided retrobulbar blockade: an imaging study. Br J Anaesth. 2008 Dec;101(6):855-9. doi: 10.1093/bja/aen293. Epub 2008 Oct 23.
PubMed 18948389Ripart J, Lefrant JY, de La Coussaye JE, Prat-Pradal D, Vivien B, Eledjam JJ. Peribulbar versus retrobulbar anesthesia for ophthalmic surgery: an anatomical comparison of extraconal and intraconal injections. Anesthesiology. 2001 Jan;94(1):56-62. doi: 10.1097/00000542-200101000-00013.
PubMed 11135722Ropo A, Nikki P, Ruusuvaara P, Kivisaari L. Comparison of retrobulbar and periocular injections of lignocaine by computerised tomography. Br J Ophthalmol. 1991 Jul;75(7):417-20. doi: 10.1136/bjo.75.7.417.
PubMed 1854695
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anaesthesia for Ophthalmic Surgery: How "Retro" is the Peribulbar Block?
- ClinicalTrials.gov ID
- NCT01258959
- Acronym / sponsor ID
- Retro-Parabulbar
- Conditions
- Ophthalmic Surgery, Parabulbar Block
- Keywords
- Ultrasound, retrobulbar, parabulbar, ophthalmic surgery.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 13 Dec 2010 (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.
Ophthalmic surgery on the posterior section of the eye can either be performed under general anaesthesia or under local aneasthesia. The local anaesthesia is performed by injecting local anaesthetics behind the eye. There are two techniques: Either the needle is placed into the muscle cone formed by the four recti muscles - this is called intraconal or retrobulbar block, or the needle is placed outside of the muscle cone - this would be called extraconal or peribulbar. In our hospital the investigators usually perform the peribulbar block since it is easier to perform and has a smaller risk to injure the eye. The investigators however realize that the parabulbar block is sometimes very efficient and sometimes not, thus requiring a second or third injection. Now investigators are able to visualize where the local anaesthetics spreads with the help of ultrasound imaging. The aim of the study is to observe and to describe the incidence of intraconal spread of local anaesthetics when a peribulbar block is performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ophthalmic surgery patients | – | Procedure: Ultrasound detection of local anesthetics spreadPatients (men and women) of at least 18 years of age undergoing an ophthalmic procedure on the posterior section of the eye under local anaesthesia, i.e. with a peribulbar block. Inclusion and exclusion criteria for the study are the same as for the peribulbar anaesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 consecutive patients (men and women) of at least 18 years of age undergoing an ophthalmic procedure on the posterior section of the eye under local anaesthesia, i.e. with a peribulbar block.
Key inclusion criteria (1 listed)
- -informed consent
Key exclusion criteria (5 listed)
- coagulation disorder
- INR over 1.5 and/or a platelet count less than 75 X 109/L,
- pathological myopia,
- inability of the patient to lie down for the operation for more than 2 hours
- lack of informed consent.
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 detection of local anesthetics spreadDuring the parabulbar injection the ultrasound operator experienced in ultrasound guided retrobulbar block will assess whether there is spread of local anaesthetic in the central cone just behind the sclera (yes or no). The anaesthesist performing the block will be blinded to the ultrasound visualized spread of local anaesthetic. | Procedure or surgery | Ophthalmic surgery patients |
Primary outcome
Incidence of detectable retrobulbar spread of local anaesthetics during peribulbar injection.
Time frame: At start (During peribulbar injection)
The outcome measure is the description of the spread of local anesthetics during the injection of the drug via the parabulbar needle.
1 secondary outcome
Assessment of block quality
Time frame: 20 Minutes after block
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 9 Jun 2011.
- Background: PubMed 18948389Luyet C, Eichenberger U, Moriggl B, Remonda L, Greif R. Real-time visualization of ultrasound-guided retrobulbar blockade: an imaging study. Br J Anaesth. 2008 Dec;101(6):855-9. doi: 10.1093/bja/aen293. Epub 2008 Oct 23.
- Background: PubMed 11135722Ripart J, Lefrant JY, de La Coussaye JE, Prat-Pradal D, Vivien B, Eledjam JJ. Peribulbar versus retrobulbar anesthesia for ophthalmic surgery: an anatomical comparison of extraconal and intraconal injections. Anesthesiology. 2001 Jan;94(1):56-62. doi: 10.1097/00000542-200101000-00013.
- Background: PubMed 1854695Ropo A, Nikki P, Ruusuvaara P, Kivisaari L. Comparison of retrobulbar and periocular injections of lignocaine by computerised tomography. Br J Ophthalmol. 1991 Jul;75(7):417-20. doi: 10.1136/bjo.75.7.417.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ophthalmic Surgery and Parabulbar Block, 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 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 9 Jun 2011. 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?
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?
Incidence of detectable retrobulbar spread of local anaesthetics during peribulbar injection. (time frame: At start (During peribulbar injection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01258959, which also lists 3 linked publications.
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 9 Jun 2011.