Efficacy of Subtenon's Block With Olive Tipped Cannula

October 14, 2021 updated by: King Khaled Eye Specialist Hospital

Efficacy of Subtenon Anesthesia With Olive Tipped Cannula: a Randomized Controlled Trial

The purpose of this study is to compare the efficacy of olive tip cannula to the standard Steven's cannula in performing subtenon's anesthesia for patients undergoing cataract surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient undergoing cataract extraction procedure under local anesthesia

Exclusion Criteria:

  • Patients allergic to local anesthetic solutions.
  • Presence local sepsis,
  • Previous retinal or strabismus surgery in the same eye.
  • Orbital abnormalities
  • Previous subtenon's block in the same quadrant.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stevens cannula
Subtenon with stevens cannula
Device: subtenon block
subtenon block with stevens cannula
Device: subtenon block
subtenon block with Olive tip cannula cannula
Experimental: Olive tip
Olive tip group
Device: subtenon block
subtenon block with stevens cannula
Device: subtenon block
subtenon block with Olive tip cannula cannula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of Akinesia score
Time Frame: 10 minutes after the block
10 minutes after the block

Secondary Outcome Measures

Outcome Measure
Time Frame
Surgeon satisfactions score
Time Frame: At the end of the procedure
At the end of the procedure

Collaborators and Investigators

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

Sponsor

King Khaled Eye Specialist Hospital

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 (Actual)

November 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

November 17, 2009

First Submitted That Met QC Criteria

November 24, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 14, 2021

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP 0928

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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