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

Ain Shams University

Status: Completed

Conditions: Peribulbar Block

Treatments: Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04036201

FMASU R 41/2019

Details and patient eligibility

About

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

Full 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.

Enrollment: 121 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

121 participants in 2 patient groups

Group 1(22-24 mm)

Experimental group

Description:

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.

Treatment:

Drug: Bupivacaine

Group 2(24.1-26 mm)

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine