Traditional Blind Versus Ultrasound-guided Peribulbar Blockade

NCT ID: NCT02151968

Last Updated: 2018-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-02-15

Brief Summary

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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.

Detailed Description

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Conditions

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Retinal and Infra-ocular Pathology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Traditional blind peribulbar block

Group Type ACTIVE_COMPARATOR

Local Anaesthetic Injection

Intervention Type PROCEDURE

Local anaesthetic is injected into the eye.

Ultrasound-guided peribulbar block

Group Type EXPERIMENTAL

Local Anaesthetic Injection

Intervention Type PROCEDURE

Local anaesthetic is injected into the eye.

Ultrasound-Guidance

Intervention Type PROCEDURE

Device: Ultrasound Machine

Peribulbar block local anaesthetic is injected into the eye with ultrasound guidance.

Interventions

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Local Anaesthetic Injection

Local anaesthetic is injected into the eye.

Intervention Type PROCEDURE

Ultrasound-Guidance

Device: Ultrasound Machine

Peribulbar block local anaesthetic is injected into the eye with ultrasound guidance.

Intervention Type PROCEDURE

Other Intervention Names

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Ultrasound Machine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Dr. Paul McHardy

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Facility Contacts

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Paul McHardy, MD

Role: primary

416-480-6100 ext. pg x 6626

Other Identifiers

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USG123

Identifier Type: -

Identifier Source: org_study_id

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