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

November 5, 2019 updated by: Renato Santiago Gomez, Federal University of Minas Gerais
Evaluate ophthalmic artery flow by echo-Doppler before and after peribulbar block with lidocaine in presence or absence of epinephrine.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130100
        • Universidade Federal de Minas Gerais, Faculdade de Medicina, Departamento de Cirurgia.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lidocaine with epinephrine
Peribulbar anesthesia with lidocaine and epinephrine
NO_INTERVENTION: Lidocaine without epinephrine
Peribulbar anesthesia with lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change on resistance index 10 minutes after peribulbar anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2013

Primary Completion (ACTUAL)

May 31, 2014

Study Completion (ACTUAL)

May 31, 2014

Study Registration Dates

First Submitted

November 3, 2019

First Submitted That Met QC Criteria

November 5, 2019

First Posted (ACTUAL)

November 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2019

Last Update Submitted That Met QC Criteria

November 5, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will be present at an official journal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Peribulbar Block

Clinical Trials on Epinephrine

Subscribe