Ophthalmic Artery Resistance Index After Peribulbar Block... | NCT04153123

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

NCT04153123

Sponsor

Federal University of Minas Gerais

Status

Completed

Last Update Posted

Nov 6, 2019Actual

Enrollment

26Actual

Phase

Not Applicable

Conditions

Ophthalmic Artery
Peribulbar Block

Interventions

Epinephrine

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2013Actual

Primary Completion Date

May 31, 2014Actual

Completion Date

May 31, 2014Actual

First Submitted Date

Nov 3, 2019

First Submission Date that Met QC Criteria

Nov 5, 2019

First Posted Date

Nov 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2019

Last Update Posted Date

Nov 6, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Renato Santiago Gomez, Professor, Federal University of Minas GeraisPrincipal Investigator

Lead Sponsor

Federal University of Minas GeraisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lidocaine with epinephrine	Experimental	Peribulbar anesthesia with lidocaine and epinephrine	Drug: Epinephrine
Lidocaine without epinephrine	No Intervention	Peribulbar anesthesia with lidocaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Epinephrine	Drug		Lidocaine with epinephrine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidade Federal de Minas Gerais, Faculdade de Medicina, Departamento de Cirurgia.		Belo Horizonte	Minas Gerais	30130100	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

The data will be present at an official journal

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004837	Epinephrine

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Quadruple

Masking Description

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.

Who Masked

ParticipantCare ProviderInvestigatorOutcomes Assessor