Anesthesia for Pars Plana Vitrectomy (PPV) With Insulin Needle

November 21, 2021 updated by: King Khaled Eye Specialist Hospital

Anesthesia for PPV Using Insulin Needle

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11462
        • King Khaled Eye Specialist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group 1
Control
Device: needle
Peribulbar blockade with standard (25 mm) needle
Other Names:
  • Peribulbar blockade with standard needle
Device: needle
Peribulbar blockade with short (12.5 mm) needle
Other Names:
  • Peribulbar blockade with short needle
Procedure: Pars Plana Vitrectomy
Peribulbar block
Other Names:
  • Extraconal block
ACTIVE_COMPARATOR: Group 2
Block with short needle
Device: needle
Peribulbar blockade with standard (25 mm) needle
Other Names:
  • Peribulbar blockade with standard needle
Device: needle
Peribulbar blockade with short (12.5 mm) needle
Other Names:
  • Peribulbar blockade with short needle
Procedure: Pars Plana Vitrectomy
Peribulbar block
Other Names:
  • Extraconal block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of insulin needle.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Khaled Eye Specialist Hospital

Investigators

  • Principal Investigator: Waleed Riad, MD, KKESH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

July 1, 2008

First Submitted That Met QC Criteria

August 14, 2008

First Posted (ESTIMATE)

August 15, 2008

Study Record Updates

Last Update Posted (ACTUAL)

December 2, 2021

Last Update Submitted That Met QC Criteria

November 21, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rp0822

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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