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Clinical Trials/NCT02151968
NCT02151968UnknownNot Applicable

Traditional Blind Versus Ultrasound-guided Peribulbar Blockade

Sunnybrook Health Sciences Centre2 sites in 1 country80 target enrollmentStarted: July 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
80
Locations
2
Primary Endpoint
Failure of peribulbar block

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Ultrasound-guided peribulbar block

Experimental

Intervention: Local Anaesthetic Injection (Procedure)

Ultrasound-guided peribulbar block

Experimental

Intervention: Ultrasound-Guidance (Procedure)

Traditional blind peribulbar block

Active Comparator

Intervention: Local Anaesthetic Injection (Procedure)

Outcomes

Primary Outcomes

Failure of peribulbar block

Time Frame: 10 minutes after block performed

Ocular Anaesthetic Scoring System (OASS) score of less than 10 will be considered inadequate for surgery and a block failure.

Secondary Outcomes

  • Quality of the block(5 and 10 min after block performed)
  • Incidence of Supplemental Peribulbar injections(Operative day 0)
  • Volume of Total Local Anaesthetic Used(Operative day 0)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Paul McHardy

Lecturer

Sunnybrook Health Sciences Centre

Study Sites (2)

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