Minimum Effective Volume of Local Anesthetic for Peribulbar Block.Does it Differ With the Eyeball Axial Length?

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04036201

Enrollment

121

Registered

2019-07-29

Start date

2019-07-31

Completion date

2019-10-10

Last updated

2019-10-22

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

Conditions

Peribulbar Block

Keywords

Peribulbar block, minimum effective volume, axial eye length

Brief summary

The aim of this study is to calculate the minimum effective volume of local anesthetic for peribulbar block in patients undergoing cataract extraction surgery.

Detailed description

The main goal of this study is to estimate the minimum effective volume(MEV90) of local anesthetic and hyaluronic acid given for local anesthesia of the eye for 2 different axial length groups of patients undergoing eye surgery. Volume assignment was carried out using a biased coin design (BCD) up-and-down sequential method (UDM), where the volume given to each patient depends on the response of the previous one. The MEV90 was calculated using isotonic regression with bias-corrected 95% confidence interval (CI) derived by boots trapping. The mean value of the estimate was obtained from 3000 bootstrap samples.

Interventions

DRUGBupivacaine

peribulbar block

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

Inclusion criteria

* we allocated adult patients aged 40-70 years, of both gender, American Society of Anesthesiologists (ASA) II - III, listed for elective cataract extraction using phaco emulsification technique with intraocular lens implantation surgery.

Exclusion criteria

* Patients known to have any systemic contraindications (as severe hypertension) or allergy to the local anesthetic, those who refused local anesthesia, high myopes (axial length \> 26 mm), patients with a single eye, those with complicated vitreous hemorrhage, ocular infection, or associated glaucoma have been excluded.

Design outcomes

Primary

Measure	Time frame	Description
The minimum effective volume of local anesthetic of the eye in relation to the eyeball axial length.	10 minutes	The minimum effective volume of local anesthetic in peribulbar block in relation to the eyeball axial length.The minimum volume which will achieve adequate sensory and motor block within 10 minutes.

Countries

Egypt

Outcome results

None listed

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