NCT00735657

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

1 year

First QC Date

July 1, 2008

Last Update Submit

November 21, 2021

Conditions

Retinal Disorders

Keywords

EfficiencyParsPlanaVitrectomy

Outcome Measures

Primary Outcomes (1)

  • Efficacy of insulin needle.

    1 year

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Control

Device: needleProcedure: Pars Plana Vitrectomy

Group 2

ACTIVE COMPARATOR

Block with short needle

Device: needleProcedure: Pars Plana Vitrectomy

Interventions

needleDEVICE

Peribulbar blockade with standard (25 mm) needle

Also known as: Peribulbar blockade with standard needle
Group 1
Pars Plana VitrectomyPROCEDURE

Peribulbar block

Also known as: Extraconal block
Group 1Group 2

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients undergoing pars plana vitrectomy under local anesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Khaled Eye Specialist hospital

Riyadh, 11462, Saudi Arabia

Location

MeSH Terms

Conditions

Retinal Diseases

Interventions

Needles

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Waleed Riad, MD

    KKESH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2008

First Posted

August 15, 2008

Study Start

August 1, 2008

Primary Completion

August 1, 2009

Study Completion

December 1, 2010

Last Updated

December 2, 2021

Record last verified: 2021-11

Locations

SA(1)