Bupivacaine vs Oxybuprocaine Topical Anesthesia in IVI

Early Phase 1

Completed

• Conditions: Pain, Acute
• Interventions: Drug: bupivacaine 0.5% and oxubuprocaine

• Registration Number: NCT05069350
• Lead Sponsor: Research Institute of Ophthalmology, Egypt

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.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-25
• Study First Posted: 2021-10-06
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-10
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All patients between 30 to 70 years

Exclusion Criteria

• uncooperative patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oxybuprocaine	bupivacaine 0.5% and oxubuprocaine	-
bupivacaine 0.5%	bupivacaine 0.5% and oxubuprocaine	-

Primary Outcome Measures

Name	Time	Method
verbal pain numerical scaling	10 minutes	11 point scale from 0-10 zero measns No pain 10 means severe unbearable pain

Trial Locations

Locations (1)

Research Institute of Ophthamology; 🇪🇬 Giza, Haram, Egypt