Traditional Blind Versus Ultrasound-guided Peribulbar Blockade

Retinal and Infra-ocular Pathology Clinical Trial

Official title:

Traditional Blind Versus Ultrasound-guided Peribulbar Blockade

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02151968
• Other study ID #: USG123
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: February 15, 2020

Study information

• Verified date: May 2018
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: February 15, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retinal and Infra-ocular Pathology

Intervention

Procedure:
• Local Anaesthetic Injection
Local anaesthetic is injected into the eye.
• Ultrasound-Guidance
Device: Ultrasound Machine Peribulbar block local anaesthetic is injected into the eye with ultrasound guidance.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

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