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

NCT04153123 | Completed

• 1 other identifier: CAAE 04433113.0.0000.5149
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ophthalmic Artery; Peribulbar Block

Keywords

ocular flow; cataract surgery; peribulbar block; ocular Doppler

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lidocaine with epinephrine

EXPERIMENTAL

Peribulbar anesthesia with lidocaine and epinephrine

Drug: Epinephrine

Lidocaine without epinephrine

NO INTERVENTION

Peribulbar anesthesia with lidocaine

Interventions

Epinephrine DRUG

Lidocaine with epinephrine

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

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

Belo Horizonte, Minas Gerais, 30130100, Brazil

Location

MeSH Terms

Interventions

Epinephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: November 3, 2019
• First Posted: November 6, 2019
• Study Start: December 1, 2013
• Primary Completion: May 31, 2014
• Study Completion: May 31, 2014
• Last Updated: November 6, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)