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NCT05069350 Clinical Trial

Bupivacaine vs Oxybuprocaine Topical Anesthesia in IVI

Pain, Acute Clinical Trial

Official title:
A Double Blinded Randomized Controlled Study of Topical Anaesthetics Oxybuprocaine Versus Bupivacaine 0.5% in Intravitreal Injections

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05069350
Other study ID # Topical anesthesia in IVI
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date September 1, 2021
Est. completion date August 1, 2022

Study information
Verified date September 2022
Source Research Institute of Ophthalmology, Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

comparing two local anaesthetic agents, Bupivacaine 0.5% versus Oxybuprocaine used topically to provide surface anaesthesia before IVI procedures.

Description:

In preparation zone, we will cannulate the patients, connect them to the pulse oximetry and we will start providing appropriate surface anaesthesia for an adequate period of time before the patient administration of the injection, by applying the anaesthetic agents, 3 times with 5 minutes interval, for 15 minutes and then waitng the injection All patients are informed that they are going to receive topical anaesthetic agent before the IVI. pain is monitored during the injection by using the 11 points verbal numerical pain scaling as zero is for no pain and 10 is for severe unbearable pain.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date August 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 70 Years
Eligibility Inclusion Criteria: - All patients between 30 to 70 years Exclusion Criteria: - uncooperative patients

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• bupivacaine 0.5% and oxubuprocaine
using each drug as surface anesthesia before intravitreal injections

Locations
Country Name City State
Egypt Research Institute of Ophthamology Giza Haram

Sponsors (1)
Lead Sponsor Collaborator
Research Institute of Ophthalmology, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary verbal pain numerical scaling 11 point scale from 0-10 zero measns No pain 10 means severe unbearable pain 10 minutes
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