Ophthalmic ArteryNCT04153123
Ophthalmic Artery Resistance Index After Peribulbar Block in the Presence of Epinephrine
A study testing Epinephrine in people with Ophthalmic Artery and Peribulbar Block, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
Evaluate ophthalmic artery flow by echo-Doppler before and after peribulbar block with lidocaine in presence or absence of epinephrine. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Ophthalmic Artery, Peribulbar Block
- What is being tested?
- Epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2013to 31 May 2014
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) I, II or III physical status classification
- Cataract surgery
Who cannot join
- glaucoma
- diabetic retinopathy
- previous eye surgery in the same eye
- ocular trauma
- allergic to any protocol medication
- uncooperative patients or cognitive difficulties
- axial eye diameter of less than 21.0 mm or greater than 25.5 mm.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Minas Gerais, Faculdade de Medicina, Departamento de Cirurgia.
Belo Horizonte, Minas Gerais, 30130100
About this study
Evaluate ophthalmic artery flow by echo-Doppler before and after peribulbar block with lidocaine in presence or absence of epinephrine.
Read the detailed description
There are controversies regarding the ophthalmic artery (OA) flow after peribulbar block with the addition of epinephrine. Therefore, we aimed to evaluate OA flow by echo-Doppler before and after peribulbar block with lidocaine in presence or absence of epinephrine.
Fifty-six patients that were eligible for cataract phacoemulsification surgery were selected. Patients were divided into two groups: group 1 - Peribulbar block with lidocaine and 1/200.000 epinephrine; group 2 - Peribulbar block with lidocaine in the absence of epinephrine. The resistance index (RI) of OA was evaluated using echo-Doppler before and 10 min after the peribulbar block.
- Conditions
- Ophthalmic Artery, Peribulbar Block
- Being tested
- Epinephrine
- Keywords
- ocular flow, cataract surgery, peribulbar block, ocular Doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpinephrineDrug
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine with epinephrine | Experimental | Peribulbar anesthesia with lidocaine and epinephrine Receives: Drug: Epinephrine |
| Lidocaine without epinephrine | No intervention | Peribulbar anesthesia with lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Artery resistance index of ophthalmic artery
The resistance index (RI) of OA was evaluated using echo-Doppler before and 10 minutes after the peribulbar block.
Measured: Change on resistance index 10 minutes after peribulbar anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 Dec 2013
- Primary completion31 May 2014
- Study completion31 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ophthalmic ArteryStudies 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
- Group 1: Peribulbar anesthesia with 2% lidocaine with epinephrine 1/200,000. Group 2: Peribulbar anesthesia with 2% lidocaine without epinephrine.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renato Santiago Gomez, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153123
- Sponsor's protocol ID
- CAAE 04433113.0.0000.5149
- Status last verified
- Nov 2019
- First submitted
- 3 Nov 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be present at an official journal
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ophthalmic Artery Resistance Index After Peribulbar Block in the Presence of Epinephrine
- ClinicalTrials.gov ID
- NCT04153123
- Acronym / sponsor ID
- CAAE 04433113.0.0000.5149
- Conditions
- Ophthalmic Artery, Peribulbar Block
- Keywords
- ocular flow, cataract surgery, peribulbar block, ocular Doppler
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 1 Dec 2013 (actual)
- Primary completion
- 31 May 2014 (actual)
- Study completion
- 31 May 2014 (actual)
- First posted
- 6 Nov 2019 (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.
Evaluate ophthalmic artery flow by echo-Doppler before and after peribulbar block with lidocaine in presence or absence of epinephrine.
Detailed description
There are controversies regarding the ophthalmic artery (OA) flow after peribulbar block with the addition of epinephrine. Therefore, we aimed to evaluate OA flow by echo-Doppler before and after peribulbar block with lidocaine in presence or absence of epinephrine.
Fifty-six patients that were eligible for cataract phacoemulsification surgery were selected. Patients were divided into two groups: group 1 - Peribulbar block with lidocaine and 1/200.000 epinephrine; group 2 - Peribulbar block with lidocaine in the absence of epinephrine. The resistance index (RI) of OA was evaluated using echo-Doppler before and 10 min after the peribulbar block.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1: Peribulbar anesthesia with 2% lidocaine with epinephrine 1/200,000. Group 2: Peribulbar anesthesia with 2% lidocaine without epinephrine.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine with epinephrine | Experimental | Drug: EpinephrinePeribulbar anesthesia with lidocaine and epinephrine |
| Lidocaine without epinephrine | No intervention | –Peribulbar anesthesia with lidocaine |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) I, II or III physical status classification
- Cataract surgery
Key exclusion criteria (7 listed)
- glaucoma
- diabetic retinopathy
- previous eye surgery in the same eye
- ocular trauma
- allergic to any protocol medication
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 |
|---|---|---|
| Epinephrine | Drug | Lidocaine with epinephrine |
Primary outcome
Artery resistance index of ophthalmic artery
Time frame: Change on resistance index 10 minutes after peribulbar anesthesia
The resistance index (RI) of OA was evaluated using echo-Doppler before and 10 minutes after the peribulbar 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 6 Nov 2019.
- Individual participant dataSharing planned: No. The data will be present at an official journal
Related trials for Ophthalmic Artery
Recruiting
The Ophthalmic Artery Doppler Evaluation Prior to Labor Induction and Adverse Intrapartum Fetal Outcomes
Ophthalmic Artery, Labor and Delivery
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?
A study testing Epinephrine in people with Ophthalmic Artery and Peribulbar Block, run by Federal University of Minas Gerais at 1 site in Brazil.
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 7 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 6 Nov 2019. 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 Brazil. 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?
Artery resistance index of ophthalmic artery (time frame: Change on resistance index 10 minutes after peribulbar anesthesia). 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 6 Nov 2019; AzTrials last refreshed its copy on 8 Nov 2026.