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Clinical Trials/NCT05069350
NCT05069350
Completed
Early Phase 1

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

Research Institute of Ophthalmology, Egypt1 site in 1 country100 target enrollmentSeptember 1, 2021

Overview

Phase
Early Phase 1
Intervention
bupivacaine 0.5% and oxubuprocaine
Conditions
Pain, Acute
Sponsor
Research Institute of Ophthalmology, Egypt
Enrollment
100
Locations
1
Primary Endpoint
verbal pain numerical scaling
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
August 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All patients between 30 to 70 years

Exclusion Criteria

  • uncooperative patients

Arms & Interventions

bupivacaine 0.5%

Intervention: bupivacaine 0.5% and oxubuprocaine

oxybuprocaine

Intervention: bupivacaine 0.5% and oxubuprocaine

Outcomes

Primary Outcomes

verbal pain numerical scaling

Time Frame: 10 minutes

11 point scale from 0-10 zero measns No pain 10 means severe unbearable pain

Study Sites (1)

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