NCT02459782

Brief Summary

Peribulbar anaesthesia for ocular surgery depends on the spread of local anaesthetic throught the orbit to be successful and has a relatively high failure rate. This study will examine a novel ultrasound guided approach to peribulbar anaesthesia which should extend the depostion of local anaesthetic by using a dual quadrant injection technique. The study will assess the feasibility of this technique, how successful it is and whether any obvious safety issues arise with its use.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
Last Updated

June 2, 2015

Status Verified

May 1, 2015

Enrollment Period

2 months

First QC Date

March 20, 2015

Last Update Submit

May 28, 2015

Conditions

Eye Diseases

Keywords

Ultrasound guided peribulbar anesthesia

Outcome Measures

Primary Outcomes (1)

  • Block Success

    Block will be deemed a failure if a supplementary block is required for the operative procedure

    10 minutes post intervention

Secondary Outcomes (5)

  • Block Quality (standardized Ocular Scoring System for akinesia and anaesthesia)

    5 and 10 minutes

  • Block Volume

    1 minute

  • Duration of Procedure

    1 to 10 minutes

  • Complications

    6 Weeks

  • Image Visualization

    1 minute

Study Arms (1)

US Guided Dual Quadrant Peribulbar block

OTHER

Ultrasound guided Dual Quadrant Peribulbar Anaesthesia

Procedure: Ultrasound guided Dual Quadrant Peribulbar Anaesthesia

Interventions

Ultrasound guided Dual Quadrant Peribulbar AnaesthesiaPROCEDURE

Landmark Guided single injection vs Ultrasound guided dual quadrant injection

US Guided Dual Quadrant Peribulbar block

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA score less than III and ability to provide a written informed consent
  • patients presenting for opthalmic surgery

You may not qualify if:

  • Coagulation disorder or anticoagulated with INR \> 1.5
  • Platelet count \< 75 X 10\*9/L
  • Significant Myopia (axial length \> 28mm)
  • Patients unable to lie supine for 2 hours
  • Patients with recent gas or silicone injections in/around the eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Eye Diseases

Study Officials

  • Paul G McHardy, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2015

First Posted

June 2, 2015

Study Start

January 1, 2012

Primary Completion

March 1, 2012

Study Completion

August 1, 2012

Last Updated

June 2, 2015

Record last verified: 2015-05