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

Adult Patients Undergoing Phacoemulsification With Topical Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143452
• Other study ID #: IndonesiaUAnes015
• Status: Completed
• Phase: N/A
• First received: May 4, 2017
• Last updated: February 27, 2018
• Start date: December 1, 2016
• Est. completion date: January 31, 2018

Study information

• Verified date: February 2018
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 31, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Patients Undergoing Phacoemulsification With Topical Anesthesia

Intervention

Drug:
• lidocaine gel
2% lidocaine gel in 1 ml syringe, applied to the eye 5 minutes before phacoemulsification
• tetracaine eye drop
0.5% tetracaine eye drop was given 5 minutes before phacoemulsification

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Central National Hospital	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (10)

Amiel H, Koch PS. Tetracaine hydrochloride 0.5% versus lidocaine 2% jelly as a topical anesthetic agent in cataract surgery: comparative clinical trial. J Cataract Refract Surg. 2007 Jan;33(1):98-100. — View Citation

Chalam KV, Murthy RK, Agarwal S, Gupta SK, Grover S. Comparative efficacy of topical tetraVisc versus lidocaine gel in cataract surgery. BMC Ophthalmol. 2009 Aug 17;9:7. doi: 10.1186/1471-2415-9-7. — View Citation

Irle S, Lückefahr MH, Tho Seeth T. [Tetracaine drops versus lidocaine gel for topical anaesthesia in cataract surgery]. Klin Monbl Augenheilkd. 2003 Sep;220(9):625-8. German. — View Citation

Jinapriya D, Almeida DR, Johnson D, Irrcher I, El-Defrawy SR. Anaesthetic plus dilating gel improves pupil dilation for cataract surgery. Can J Ophthalmol. 2012 Apr;47(2):145-9. doi: 10.1016/j.jcjo.2012.01.007. Epub 2012 Mar 14. — View Citation

Rafailov L, Kulak A, Weedon J, Shinder R. Comparison of Lidocaine Gel-Assisted Transconjunctival and Transcutaneous Local Anesthesia for Outpatient Eyelid Surgery. Ophthal Plast Reconstr Surg. 2015 Nov-Dec;31(6):470-3. doi: 10.1097/IOP.0000000000000391. — View Citation

Shah H, Reichel E, Busbee B. A novel lidocaine hydrochloride ophthalmic gel for topical ocular anesthesia. Local Reg Anesth. 2010;3:57-63. Epub 2010 Aug 10. — View Citation

Shiroma HF, Shimono KE, Farah ME, Goldhardt R, Grumann A Jr, Rodrigues EB. Comparative Study Between Lidocaine Gel 2% and 5% for Ophthalmic Procedures. J Ocul Pharmacol Ther. 2016 May;32(4):192-5. doi: 10.1089/jop.2015.0002. Epub 2016 Jan 20. — View Citation

Soliman MM, Macky TA, Samir MK. Comparative clinical trial of topical anesthetic agents in cataract surgery: lidocaine 2% gel, bupivacaine 0.5% drops, and benoxinate 0.4% drops. J Cataract Refract Surg. 2004 Aug;30(8):1716-20. — View Citation

Tsoumani AT, Asproudis IC, Damigos D. Tetracaine 0.5% eyedrops with or without lidocaine 2% gel in topical anesthesia for cataract surgery. Clin Ophthalmol. 2010 Sep 7;4:967-70. — View Citation

Waheeb S. Topical anesthesia in phacoemulsification. Oman J Ophthalmol. 2010 Sep;3(3):136-9. doi: 10.4103/0974-620X.71892. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale	assessing subject's pain with visual analog scale	Day 1
Secondary	Additional topical anesthesia requirement	Number of additional topical anesthesia given after the first dose	Day 1
Secondary	Subjects and surgeon's satisfactory	Assessment is done using questionnaire	Day 1