Comparison Between 2% Lidocaine Gel and 5% Tetracaine Eye Drop as Topical Anesthesia in Phacoemulsification

Universitas Indonesia72 enrolled

Overview

This study aimed to compare the efficacy between 2% lidocaine gel vs 0.5% tetracaine eye drop as topical anesthesia in phacoemulsification

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups (Lidocaine gel and tetracaine eye drop group). Lidocaine group received 2% lidocaine gel in 1 ml syringe, applied to the eye. Tetracaine group received 0.5% tetracaine eye drop. Topical anesthesia was given 5 minutes before phacoemulsification. Five minutes after phacoemulsification finished, visual analog score (VAS) and subjects and surgeon's satisfaction were assessed. Every additional topical anesthesia needed was recorded.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Adult Patients Undergoing Phacoemulsification With Topical Anesthesia

Interventions

lidocaine gelDRUG

2% lidocaine gel in 1 ml syringe, applied to the eye 5 minutes before phacoemulsification

tetracaine eye dropDRUG

0.5% tetracaine eye drop was given 5 minutes before phacoemulsification

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients aged more than 40 years old who were planned to undergo elective phacoemulsification with intraocular lens implantation at operating room. The surgery was operated by an experienced ophthalmologist. Subjects had been explained about the study, and agreed to enroll and have signed the informed consent form. Exclusion Criteria: * Subjects with history of allergy to topical anesthesia (2% lidocaine gel and 0.5% tetracaine eye drop), subjects who used another method of intraoperative anesthesia other than topical anesthesia, subjects with history of phacoemulsification before, subjects with difficulty in communication, dementia, and anxiety. Dropout Criteria: * Phacoemulsifications duration more than 30 minutes, and subjects who resigned from the study before the study ended

Locations (1)

Cipto Mangunkusumo Central National Hospital

Jakarta, Indonesia

Outcomes

Primary Outcomes

Visual analog scale

assessing subject's pain with visual analog scale

Time frame: Day 1

Secondary Outcomes

Additional topical anesthesia requirement

Number of additional topical anesthesia given after the first dose

Time frame: Day 1

Subjects and surgeon's satisfactory

Assessment is done using questionnaire

Time frame: Day 1

Data from ClinicalTrials.gov

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