Bupivacaine vs Oxybuprocaine Topical Anesthesia in IVI

NCT ID: NCT05069350

Last Updated: 2022-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-08-01

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.

Conditions

Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

bupivacaine 0.5%

Group Type: EXPERIMENTAL

bupivacaine 0.5% and oxubuprocaine

Intervention Type: DRUG

using each drug as surface anesthesia before intravitreal injections

oxybuprocaine

Group Type: EXPERIMENTAL

bupivacaine 0.5% and oxubuprocaine

Intervention Type: DRUG

using each drug as surface anesthesia before intravitreal injections

Interventions

bupivacaine 0.5% and oxubuprocaine

using each drug as surface anesthesia before intravitreal injections

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• All patients between 30 to 70 years

Exclusion Criteria

• uncooperative patients

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Research Institute of Ophthalmology, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Institute of Ophthamology

Giza, Haram, Egypt

Countries

Egypt

Other Identifiers

Topical anesthesia in IVI

Identifier Type: -

Identifier Source: org_study_id