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Traditional Blind Versus Ultrasound-guided Peribulbar Blockade

Traditional Blind Versus Ultrasound-guided Peribulbar Blockade

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02151968
Enrollment
80
Registered
2014-06-02
Start date
2019-07-01
Completion date
2020-02-15
Last updated
2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal and Infra-ocular Pathology

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.

Interventions

Local anaesthetic is injected into the eye.

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

Sponsors

Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Failure of peribulbar block10 minutes after block performedOcular Anaesthetic Scoring System (OASS) score of less than 10 will be considered inadequate for surgery and a block failure.

Secondary

MeasureTime frameDescription
Quality of the block5 and 10 min after block performedQuality 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 injectionsOperative day 0To 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 UsedOperative day 0The total volume of local anaesthetic used for peribulbar block preoperatively and intraoperatively.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026