Bilateral Peribulbar Block for Cataract Surgery

Recruiting

• Conditions: Peribulbar Block; Safety; Efficacy; Cataract Surgery; Bilateral

• Registration Number: NCT07000669
• Lead Sponsor: Tanta University

Brief Summary

This study aims to evaluate the safety and efficacy of bilateral peribulbar block for cataract surgery.

Detailed Description

Cataract surgery is one of the most commonly performed procedures worldwide, with local anesthesia being the preferred method due to its safety, efficacy, and cost-effectiveness.

Peribulbar anaesthesia has gained popularity due to its relative efficacy in generating ocular akinesia and anaesthesia with a reduced risk of consequences such as optic nerve damage and globe perforation.

Study Timeline

• Study First Submitted: 2025-05-24
• Study First Submitted QC: 2025-05-24
• Status Verified: 2025-06
• Study Start: 2025-06-03
• Study First Posted: 2025-06-03
• Last Update Submitted: 2025-06-03
• Last Update Posted: 2025-06-04
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age ≥ 18 years.
• Both sexes.
• American Society of Anesthesiology (ASA) physical status I-III.
• Patients undergoing cataract surgery

Exclusion Criteria

• Infection at the site of the surgery.
• Allergy to any of the used drugs.
• Coagulopathy.
• Posterior staphyloma.
• Bronchial asthma.
• Bradyarrhythmia.
• Pre-existing ocular muscle paresis.
• Neurological deficit.
• Co-existing inflammatory conditions of eye.
• Complicated cataracts.
• Previously operated eyes.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Degree of pain	Intraoperatively	The pain will be evaluated by straightforward questioning using a 3-point scoring method (no pain = 0, discomfort = 1, pain = 2) during the procedure.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	24 hours postoperatively	The point in time to satisfactory surgical anesthesia will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Grading of Akinesia	Intraoperatively	Motor block will be assessed by estimation of globe akinesia in the four quadrants, discriminated by the 4 directions of the gaze: lateral, medial, superior, and inferior. A 3- point scoring method will be chosen, in which 0 = akinesia, 1 = incomplete akinesia, and 2 = natural movement, with a total score ranging from 0-8 for the four muscles.
Incidence of adverse events	24 hours postoperatively	Incidence of adverse events such as coughing, vomiting, hypotension, bradycardia, tachycardia, arrhythmias, proptosis, globe puncture, or retrobulbar hemorrhage will be recorded.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt