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

Sponsor
Indonesia University (Other)
Overall Status
Completed
CT.gov ID
NCT03143452
Collaborator
(none)
72
Enrollment
1
Location
2
Arms
14
Actual Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: lidocaine gel
  • Drug: tetracaine eye drop
 N/A

Detailed Description

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 Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Comparison Between 2% Lidocaine Gel and 5% Tetracaine Eye Drop as Topical Anesthesia in Phacoemulsification
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Jan 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: lidocaine gel

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

Drug: lidocaine gel
2% lidocaine gel in 1 ml syringe, applied to the eye 5 minutes before phacoemulsification
Active Comparator: tetracaine eye drop

Tetracaine eye drop group: received 0.5% tetracaine eye drop 5 minutes before phacoemulsification

Drug: tetracaine eye drop
0.5% tetracaine eye drop was given 5 minutes before phacoemulsification

Outcome Measures

Primary Outcome Measures

  1. Visual analog scale [Day 1]

    assessing subject's pain with visual analog scale

Secondary Outcome Measures

  1. Additional topical anesthesia requirement [Day 1]

    Number of additional topical anesthesia given after the first dose

  2. Subjects and surgeon's satisfactory [Day 1]

    Assessment is done using questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cipto Mangunkusumo Central National Hospital Jakarta Indonesia 10430

Sponsors and Collaborators

  • Indonesia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Susilo Chandra, Anesthesiologist Consultant, Indonesia University
ClinicalTrials.gov Identifier:
NCT03143452
Other Study ID Numbers:
  • IndonesiaUAnes015
First Posted:
May 8, 2017
Last Update Posted:
Feb 28, 2018
Last Verified:
Feb 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lidocaine
Tetracaine
Ophthalmic Solutions

Study Results

No Results Posted as of Feb 28, 2018