Traditional Blind Versus Ultrasound-guided Peribulbar Blockade

NCT02151968 | Unknown

• 1 other identifier: USG123
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal and Infra-ocular Pathology

Outcome Measures

Primary Outcomes (1)

• Failure of peribulbar block

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

  10 minutes after block performed

Secondary Outcomes (3)

• 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

Study Arms (2)

Traditional blind peribulbar block

ACTIVE COMPARATOR

Procedure: Local Anaesthetic Injection

Ultrasound-guided peribulbar block

EXPERIMENTAL

Procedure: Local Anaesthetic Injection; Procedure: Ultrasound-Guidance

Interventions

Local Anaesthetic Injection PROCEDURE

Local anaesthetic is injected into the eye.

Traditional blind peribulbar block; Ultrasound-guided peribulbar block

Ultrasound-Guidance PROCEDURE

Device: Ultrasound Machine Peribulbar block local anaesthetic is injected into the eye with ultrasound guidance.

Also known as: Ultrasound Machine

Ultrasound-guided peribulbar block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing vitrectomy surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Interventions

Anesthesia, Local

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: June 2, 2014
• Study Start: July 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: February 15, 2020
• Last Updated: May 7, 2018

Record last verified: 2018-05

Locations

CA (1)