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

Not Applicable

Completed

• Conditions: Peribulbar Block
• Interventions: Drug: Bupivacaine

• Registration Number: NCT04036201
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-07-26
• Study First Posted: 2019-07-29
• Study Start: 2019-07-31
• Status Verified: 2019-10
• Primary Completion: 2019-10-10
• Study Completion: 2019-10-10
• Last Update Submitted: 2019-10-18
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2(24.1-26 mm)	Bupivacaine	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 1(22-24 mm)	Bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Faculty of Medicine ,Ain Shams University; 🇪🇬 Cairo, القاهرة, Egypt