Ultrasound Guided Peribulbar Anaesthesia - A Novel Dual Quadrant Injection Technique

Eye Diseases Clinical Trial

Official title:

Ultrasound Guided Peribulbar Anaesthesia: a Real-time Ultrasound Guided Technique With a Novel Dual Quadrant Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459782
• Other study ID #: 424-2011
• Status: Completed
• Phase: N/A
• First received: March 20, 2015
• Last updated: May 28, 2015
• Start date: January 2012
• Est. completion date: August 2012

Study information

• Verified date: May 2015
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Eye Diseases

Intervention

Procedure:
• Ultrasound guided Dual Quadrant Peribulbar Anaesthesia
Landmark Guided single injection vs Ultrasound guided dual quadrant injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Block Success	Block will be deemed a failure if a supplementary block is required for the operative procedure	10 minutes post intervention	No
Secondary	Block Quality (standardized Ocular Scoring System for akinesia and anaesthesia)	Block will be assessed according to a standardized Ocular Scoring System for akinesia and anaesthesia at 5 minutes and 10 minutes post block. This is a composite measure	5 and 10 minutes	No
Secondary	Block Volume	Total volume of local anaesthetic will be recorded. Volume for each part of the dual injection technique will also be recorded. This is a composite measure.	1 minute	No
Secondary	Duration of Procedure	The duration of the entire procedure will be recorded	1 to 10 minutes	No
Secondary	Complications	Any complications during the procedure or in follow up clinical visits will be recorded	6 Weeks	No
Secondary	Image Visualization	Operator's ability to see the needle in both the infero-lateral and infero-medial injection will be recorded. Ability to see perineural, retrobulbar and medial rectus spread of local anaesthetic will be recorded. This is a composite qualitative measure.	1 minute	No