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Clinical Trials/NCT04036201
NCT04036201
Completed
Not Applicable

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

Ain Shams University1 site in 1 country121 target enrollmentJuly 31, 2019
InterventionsBupivacaine

Overview

Phase
Not Applicable
Intervention
Bupivacaine
Conditions
Peribulbar Block
Sponsor
Ain Shams University
Enrollment
121
Locations
1
Primary Endpoint
The minimum effective volume of local anesthetic of the eye in relation to the eyeball axial length.
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 31, 2019
End Date
October 10, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Walid Nofal

Assisstant Professor of Anesthesiology

Ain Shams University

Eligibility Criteria

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.

Arms & Interventions

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.

Intervention: Bupivacaine

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

Intervention: Bupivacaine

Outcomes

Primary Outcomes

The minimum effective volume of local anesthetic of the eye in relation to the eyeball axial length.

Time Frame: 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.

Study Sites (1)

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