Traditional Blind Versus Ultrasound-guided Peribulbar Blockade

May 2, 2018 updated by: Dr. Paul McHardy, Sunnybrook Health Sciences Centre
Eye surgeries are traditionally performed under local anaesthesia with a peribulbar block. This is a blind technique where local anaesthetic is injected into the back of the eye to make the eye numb and motionless for surgery. This is a blind injection and can be associated with complications such as bleeding, rupture of eye globe, blindness, increasing the pressure of the eye etc. It also has a high failure rate resulting in need for additional injections, further exposing the patient to possible complications. The investigators propose to perform the peribulbar block with ultrasound to guide the block needle placement and injection. The investigators hypothesize that ultrasound guided peribulbar blocks would have higher success rate (less need for additional injections) and that the total amount of local anaesthetics used would be decreased.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing vitrectomy surgery

Exclusion Criteria:

  • Lack of informed consent
  • Coagulopathic disorder, anticoagulated with INR (international normalized ratio) > 1.5 or platelet count less than 75 x 10^9/L
  • Pathological myopia. Inability of patient to lie down for 2 hours for the operation -Local infection at site of needle entry

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional blind peribulbar block
Procedure: Local Anaesthetic Injection
Local anaesthetic is injected into the eye.
Experimental: Ultrasound-guided peribulbar block
Procedure: Local Anaesthetic Injection
Local anaesthetic is injected into the eye.
Procedure: Ultrasound-Guidance

Device: Ultrasound Machine

Peribulbar block local anaesthetic is injected into the eye with ultrasound guidance.

Other Names:
  • Ultrasound Machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure of peribulbar block
Time Frame: 10 minutes after block performed
Ocular Anaesthetic Scoring System (OASS) score of less than 10 will be considered inadequate for surgery and a block failure.
10 minutes after block performed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of the block
Time Frame: 5 and 10 min after block performed
Quality of the block based on the OASS score will be classified as poor (0-3), average (4-9) and good (10-14).
5 and 10 min after block performed
Incidence of Supplemental Peribulbar injections
Time Frame: Operative day 0
To determine incidence of additional peribulbar injections after failure of original block as determined preoperatively by the anaesthetist or intraoperatively by the surgeon.
Operative day 0
Volume of Total Local Anaesthetic Used
Time Frame: Operative day 0
The total volume of local anaesthetic used for peribulbar block preoperatively and intraoperatively.
Operative day 0

Collaborators and Investigators

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

Sponsor

Sunnybrook Health Sciences Centre

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 (Anticipated)

July 1, 2019

Primary Completion (Anticipated)

November 30, 2019

Study Completion (Anticipated)

February 15, 2020

Study Registration Dates

First Submitted

May 20, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (Estimate)

June 2, 2014

Study Record Updates

Last Update Posted (Actual)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USG123

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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