Ophthalmic Artery Resistance Index After Peribulbar Block in the Presence of Epinephrine

NCT ID: NCT04153123

Last Updated: 2019-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-01

Study Completion Date

2014-05-31

Brief Summary

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Evaluate ophthalmic artery flow by echo-Doppler before and after peribulbar block with lidocaine in presence or absence of epinephrine.

Detailed Description

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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

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Ophthalmic Artery Peribulbar Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group 1: Peribulbar anesthesia with 2% lidocaine with epinephrine 1/200,000.

Group 2: Peribulbar anesthesia with 2% lidocaine without epinephrine.
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The preparation of the syringes was performed by one of the researchers not involved in the execution of the blockades. The same anesthesiologist performed all the blocks, while the same ophthalmologist did the ocular monitoring measures.

Study Groups

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Lidocaine with epinephrine

Peribulbar anesthesia with lidocaine and epinephrine

Group Type EXPERIMENTAL

Epinephrine

Intervention Type DRUG

Lidocaine without epinephrine

Peribulbar anesthesia with lidocaine

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Epinephrine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists (ASA) I, II or III physical status classification
* Cataract surgery

Exclusion Criteria

* 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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Renato Santiago Gomez

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidade Federal de Minas Gerais, Faculdade de Medicina, Departamento de Cirurgia.

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CAAE 04433113.0.0000.5149

Identifier Type: -

Identifier Source: org_study_id

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