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Completed

NCT Number: NCT02459782

Ultrasound Guided Peribulbar Anaesthesia - A Novel Dual Quadrant Injection Technique

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.

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound guided Dual Quadrant Peribulbar Anaesthesia

Procedure

Landmark Guided single injection vs Ultrasound guided dual quadrant injection

Primary outcomes

  1. Block Success

    Time frame: 10 minutes post intervention

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

Secondary outcomes

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

    Time frame: 5 and 10 minutes

    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

  2. Block Volume

    Time frame: 1 minute

    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.

  3. Duration of Procedure

    Time frame: 1 to 10 minutes

    The duration of the entire procedure will be recorded

  4. Complications

    Time frame: 6 Weeks

    Any complications during the procedure or in follow up clinical visits will be recorded

  5. Image Visualization

    Time frame: 1 minute

    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.

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 2, 2015
Registry last updated
Jun 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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