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Traditional Blind Versus Ultrasound-guided Peribulbar Blockade

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Unknown status
CT.gov ID
NCT02151968
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
7.5
Anticipated Duration (Months)
10.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Local Anaesthetic Injection
  • Procedure: Ultrasound-Guidance
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Traditional Blind Versus Ultrasound-guided Peribulbar Blockade
Anticipated Study Start Date :
Jul 1, 2019
Anticipated Primary Completion Date :
Nov 30, 2019
Anticipated Study Completion Date :
Feb 15, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Failure of peribulbar block [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.

    Secondary Outcome Measures

    1. Quality of the block [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).

    2. Incidence of Supplemental Peribulbar injections [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.

    3. Volume of Total Local Anaesthetic Used [Operative day 0]

      The total volume of local anaesthetic used for peribulbar block preoperatively and intraoperatively.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5

    Sponsors and Collaborators

    • Sunnybrook Health Sciences Centre

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Paul McHardy, Lecturer, Sunnybrook Health Sciences Centre
    ClinicalTrials.gov Identifier:
    NCT02151968
    Other Study ID Numbers:
    • USG123
    First Posted:
    Jun 2, 2014
    Last Update Posted:
    May 7, 2018
    Last Verified:
    May 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Anesthetics
    Anesthetics, Local

    Study Results

    No Results Posted as of May 7, 2018