Ultrasound Guided Peribulbar Anaesthesia - A Novel Dual Quadrant Injection Technique

NCT ID: NCT02459782

Last Updated: 2015-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-08-31

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.

Detailed Description

Peribulbar anesthesia is widely used for anterior and posterior chamber ophthalmic procedures. It is a blind technique which is traditionally carried out by inserting a needle in the infero-lateral aspect of the orbit below the globe and injecting a volume of 8 - 12 mL of local anesthetic in the periorbital space. The goal of this inejction is to achieve akinesia and anesthesia of the eye sufficient for surgery. The technique has a relatively high failure rate of up to 30%. A failure or insufficient block requires a second or rarely a third peribulbar injection to achieve success. Ultrasound can be used to guide needles in the human body and has been successfully used in many anatomic locations for anaesthesia. This study will assess whether ultrasound can guide the block needle in ophthalmic anesthesia to deliver local anesthetic via a single entry into two discrete locations within the periorbital space - the first in the infero-lateral quadrant and the second in the infero-medial quadrant. If this can be done the investigators may achieve a higher success rate for this block with a lower volume potentially improving the quality of the block and its safety.

Conditions

Eye Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

US Guided Dual Quadrant Peribulbar block

Ultrasound guided Dual Quadrant Peribulbar Anaesthesia

Group Type: OTHER

Ultrasound guided Dual Quadrant Peribulbar Anaesthesia

Intervention Type: PROCEDURE

Landmark Guided single injection vs Ultrasound guided dual quadrant injection

Interventions

Ultrasound guided Dual Quadrant Peribulbar Anaesthesia

Landmark Guided single injection vs Ultrasound guided dual quadrant injection

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul G McHardy, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Other Identifiers

424-2011

Identifier Type: -

Identifier Source: org_study_id