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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-31

Study Completion Date

2019-10-10

Brief Summary

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

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Detailed Description

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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.

Conditions

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Peribulbar Block

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group 1(22-24 mm)

Group 1 (patients with axial length between 22 and 24 mm): received a mixture of bupivacaine 0.5% (3ml) + lidocaine 2% (3ml) + hyalurindase 150 IU (1 ml) to a total volume of 7 ml.

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

peribulbar block

Group 2(24.1-26 mm)

Group 2 (patients with axial length between 24.1 and 26 mm): received a mixture of bupivacaine 0.5% (3ml) + lidocaine 2% (3ml) + hyaluronidase 150 IU (1 ml) to a total volume of 7 m

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

peribulbar block

Interventions

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Bupivacaine

peribulbar block

Intervention Type DRUG

Other Intervention Names

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hyaluronic acid

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No