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

Sponsor

Federal University of Minas Gerais (Other)

Overall Status

Completed

CT.gov ID

NCT04153123

Collaborator

(none)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ophthalmic Artery Peribulbar Block	Drug: Epinephrine	N/A

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

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Group 1: Peribulbar anesthesia with 2% lidocaine with epinephrine 1/200,000. Group 2: Peribulbar anesthesia with 2% lidocaine without epinephrine.Group 1: Peribulbar anesthesia with 2% lidocaine with epinephrine 1/200,000. Group 2: Peribulbar anesthesia with 2% lidocaine without epinephrine.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

May 31, 2014

Actual Study Completion Date :

May 31, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lidocaine with epinephrine Peribulbar anesthesia with lidocaine and epinephrine	Drug: Epinephrine
No Intervention: Lidocaine without epinephrine Peribulbar anesthesia with lidocaine

Arm

Intervention/Treatment

Experimental: Lidocaine with epinephrine

Peribulbar anesthesia with lidocaine and epinephrine

Drug: Epinephrine

No Intervention: Lidocaine without epinephrine

Peribulbar anesthesia with lidocaine

Outcome Measures

Primary Outcome Measures

Artery resistance index of ophthalmic artery [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidade Federal de Minas Gerais, Faculdade de Medicina, Departamento de Cirurgia.	Belo Horizonte	Minas Gerais	Brazil	30130100

Sponsors and Collaborators

Federal University of Minas Gerais

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Renato Santiago Gomez, Professor, Federal University of Minas Gerais

ClinicalTrials.gov Identifier:

NCT04153123

Other Study ID Numbers:

CAAE 04433113.0.0000.5149

First Posted:

Nov 6, 2019

Last Update Posted:

Nov 6, 2019

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Renato Santiago Gomez, Professor, Federal University of Minas Gerais

Additional relevant MeSH terms:

Epinephrine

Study Results

No Results Posted as of Nov 6, 2019