Back to resultsBupivacaine vs Oxybuprocaine Topical Anesthesia in IVI
Primary Purpose
Pain, Acute
Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
bupivacaine 0.5% and oxubuprocaine
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Acute
Eligibility Criteria
Inclusion Criteria:
- All patients between 30 to 70 years
Exclusion Criteria:
- uncooperative patients
Sites / Locations
- Research Institute of Ophthamology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
bupivacaine 0.5%
oxybuprocaine
Arm Description
Outcomes
Primary Outcome Measures
verbal pain numerical scaling
11 point scale from 0-10 zero measns No pain 10 means severe unbearable pain
Secondary Outcome Measures
Full Information
NCT ID
NCT05069350
First Posted
September 14, 2021
Last Updated
September 10, 2022
Sponsor
Research Institute of Ophthalmology, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT05069350
Brief Title
Bupivacaine vs Oxybuprocaine Topical Anesthesia in IVI
Official Title
A Double Blinded Randomized Controlled Study of Topical Anaesthetics Oxybuprocaine Versus Bupivacaine 0.5% in Intravitreal Injections
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Research Institute of Ophthalmology, Egypt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
double blinded randomized syudy
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bupivacaine 0.5%
Arm Type
Experimental
Arm Title
oxybuprocaine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bupivacaine 0.5% and oxubuprocaine
Intervention Description
using each drug as surface anesthesia before intravitreal injections
Primary Outcome Measure Information:
Title
verbal pain numerical scaling
Description
11 point scale from 0-10 zero measns No pain 10 means severe unbearable pain
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All patients between 30 to 70 years
Exclusion Criteria:
uncooperative patients
Facility Information:
Facility Name
Research Institute of Ophthamology
City
Giza
State/Province
Haram
ZIP/Postal Code
12513
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bupivacaine vs Oxybuprocaine Topical Anesthesia in IVI
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