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

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

Study Overview

• Status: Completed
• Conditions: Peribulbar Block
• Intervention / Treatment: Drug: Bupivacaine

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 Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • القاهرة
    • Cairo, القاهرة, Egypt, 11566
      • Faculty of Medicine ,Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Bupivacaine; peribulbar block; Other Names: hyaluronic acid
EXPERIMENTAL: 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	Drug: Bupivacaine; peribulbar block; Other Names: hyaluronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The minimum effective volume of local anesthetic of the eye in relation to the eyeball axial length.	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.	10 minutes

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: WALID Nofal, MD, Faculty of Medicine, Ain Shams University; Principal Investigator: Sanaa el Fawal, MD, Faculty of Medicine, Ain Shams University; Principal Investigator: Wail Abdelaal, MD, Faculty of Medicine, Ain Shams University; Principal Investigator: Eman Sabek, MD, National Centre of Radiation Research and Technology, Atomic Energy Authority

Publications and helpful links

General Publications

• El Fawal SM, Nofal WH, Sabek EAS, Abdelaal WA. Minimum effective volume of local anesthetic in peribulbar block: does it differ with the eyeball axial length? Braz J Anesthesiol. 2021 Nov-Dec;71(6):635-641. doi: 10.1016/j.bjane.2021.09.001. Epub 2021 Sep 22.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 31, 2019
• Primary Completion (ACTUAL): October 10, 2019
• Study Completion (ACTUAL): October 10, 2019

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (ACTUAL): July 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 18, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: minimum effective volume; Peribulbar block; axial eye length
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Anesthetics, Local; Viscosupplements; Bupivacaine; Hyaluronic Acid
• Other Study ID Numbers: FMASU R 41/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No