Bupivacaine vs Oxybuprocaine Topical Anesthesia in IVI | NCT05069350

Studies
Bupivacaine vs Oxybuprocaine Topical Anesthesia in IVI

NCT05069350

Sponsor

Research Institute of Ophthalmology, Egypt

Status

Completed

Last Update Posted

Sep 13, 2022Actual

Enrollment

100Actual

Phase

Early Phase 1

Conditions

Pain, Acute

Interventions

bupivacaine 0.5% and oxubuprocaine

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Actual

Primary Completion Date

Aug 1, 2022Actual

Completion Date

Aug 1, 2022Actual

First Submitted Date

Sep 14, 2021

First Submission Date that Met QC Criteria

Sep 25, 2021

First Posted Date

Oct 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2022

Last Update Posted Date

Sep 13, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bupivacaine 0.5%	Experimental		Drug: bupivacaine 0.5% and oxubuprocaine
oxybuprocaine	Experimental		Drug: bupivacaine 0.5% and oxubuprocaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bupivacaine 0.5% and oxubuprocaine	Drug	using each drug as surface anesthesia before intravitreal injections	bupivacaine 0.5% oxybuprocaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
verbal pain numerical scaling	11 point scale from 0-10 zero measns No pain 10 means severe unbearable pain	10 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients between 30 to 70 years

Exclusion Criteria:

uncooperative patients

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Institute of Ophthamology		Giza	Haram	12513	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059787	Acute Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided