Traditional Blind Versus Ultrasound-guided Peribulbar Blockade

Not Applicable

• Conditions: Retinal and Infra-ocular Pathology
• Interventions: Procedure: Local Anaesthetic Injection; Procedure: Ultrasound-Guidance

• Registration Number: NCT02151968
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-06-02
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-07
• Study Start: 2019-07-01
• Primary Completion: 2019-11-30
• Study Completion: 2020-02-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional blind peribulbar block	Local Anaesthetic Injection	-
Ultrasound-guided peribulbar block	Local Anaesthetic Injection	-
Ultrasound-guided peribulbar block	Ultrasound-Guidance	-

Primary Outcome Measures

Name	Time	Method
Failure of peribulbar block	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 Outcome Measures

Name	Time	Method
Quality of the block	5 and 10 min after block performed	Quality of the block based on the OASS score will be classified as poor (0-3), average (4-9) and good (10-14).
Incidence of Supplemental Peribulbar injections	Operative day 0	To determine incidence of additional peribulbar injections after failure of original block as determined preoperatively by the anaesthetist or intraoperatively by the surgeon.
Volume of Total Local Anaesthetic Used	Operative day 0	The total volume of local anaesthetic used for peribulbar block preoperatively and intraoperatively.

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada