Anesthesia for Pars Plana Vitrectomy (PPV) With Insulin N... | NCT00735657

Studies
Anesthesia for Pars Plana Vitrectomy (PPV) With Insulin Needle

NCT00735657

Sponsor

King Khaled Eye Specialist Hospital

Status

Completed

Last Update Posted

Dec 2, 2021Actual

Enrollment

120Actual

Phase

Not Applicable

Conditions

Retinal Disorders

Interventions

needle
needle
Pars Plana Vitrectomy

Countries

Saudi Arabia

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

Nov 2021

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

Aug 2008

Primary Completion Date

Aug 2009Actual

Completion Date

Dec 2010Actual

First Submitted Date

Jul 1, 2008

First Submission Date that Met QC Criteria

Aug 14, 2008

First Posted Date

Aug 15, 2008Estimated

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

Nov 21, 2021

Last Update Posted Date

Dec 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Periocular blockade with 12.5 mm needle is as effective as block with 25 mm needle for patients undergoing Pars Plana Vitrectomy.

Detailed Description

The author wants to see the effect of short needle in patients undergoing retinal surgery.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Active Comparator	Control	Device: needle Procedure: Pars Plana Vitrectomy
Group 2	Active Comparator	Block with short needle	Device: needle Procedure: Pars Plana Vitrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
needle	Device	Peribulbar blockade with standard (25 mm) needle	Group 1

Measure	Description	Time Frame
Efficacy of insulin needle.		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients undergoing pars plana vitrectomy under local anesthesia

Exclusion Criteria:

Patients allergic to local anesthetic solutions
With local sepsis
Serious impairment of coagulation
Orbital abnormalities
Unable to cooperate in maintaining a relatively motionless supine position
Who refused the anesthetic technique

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Waleed Riad, MD	KKESH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King Khaled Eye Specialist hospital		Riyadh		11462	Saudi Arabia