Comparison of Patient Comfort After Two Anesthetic Protocols for Injections Into the Eye

Pain Clinical Trial

Official title:

Clinical Comparison of Two Anesthetic Preparations for Intravitreal Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087489
• Other study ID #: 00825
• Status: Completed
• Phase: N/A
• First received: March 15, 2010
• Last updated: November 19, 2012
• Start date: April 2010
• Est. completion date: June 2011

Study information

• Verified date: November 2012
• Source: Miami VA Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Patient comfort during and after eye injections will be compared after two numbing (anesthetic) protocols, an eye preparation utilizing three cotton swabs soaked in 4% lidocaine drops versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel.

Description:

The primary goal of this investigation is to determine the relative comfort of an intravitreal injection (same day and the next day) after a preparation utilizing three cotton swabs soaked in 4% lidocaine versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel. Based on the available data, the researchers contend that a preparation based on viscous 3.5% ophthalmic lidocaine gel, which coats the surface and remains in contact with the eye longer, may provide greater anesthesia and result in greater patient comfort than the topical 4% lidocaine, which is part of the standard preparation routinely utilized in the ophthalmology department currently. Secondary outcome measure is the intraocular pressure rise after the injection, and the authors will generate prospective data to study whether softening the eye with cotton swabs prior to the injection lowers post-injection pressure spike.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has required repeat Ranibizumab injections and has had at least 3 injections prior to recruitment

• Informed consent

• Age = 18 years

• Clinical need for a therapeutic ranibizumab intravitreal injection regardless of the medical indication

• Able to understand and read English

Exclusion Criteria:

• Pregnancy (positive pregnancy test)

• Mental disability

• Prisoners

• Patients with fluctuating or impaired decision-making capacity

• Inability to comply with study or follow-up procedures

• Previous reaction to the same drug class

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• 4% lidocaine
The eye will be topically anesthetized with 0.5% proparacaine drops and 4% lidocaine drops and a 10% povidone-iodine scrub of the lids and lashes will be performed. A sterile speculum will be placed between the lids. Five percent povidone-iodine drops will then be applied over the ocular surface followed in three rounds by additional 5% povidone iodine and a sterile cotton swab soaked in sterile 4% lidocaine applied with gentle pressure to the area designated for injection in the infero-temporal quadrant.
• 3.5% ophthalmic lidocaine gel
The eye will be topically anesthetized with 0.5% proparacaine drops and 5% povidone iodine will be placed over the eye. Two drops of preservative-free 3.5% lidocaine hydrochloride ophthalmic gel will be placed into inferior conjunctival sac. The patient will be asked to close the eye for 7 minutes. Next, a 10% povidone-iodine scrub of the lids and lashes will be performed. A sterile speculum will be placed between the lids. Five percent povidone-iodine drops will then be applied over the ocular surface and allowed to remain in contact with the eye for at least 2 minutes. The eye will then be rinsed with antibiotic drops.

Locations

Country	Name	City	State
United States	Miami Veterans Affairs Medical Center	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Miami VA Healthcare System	Bascom Palmer Eye Institute, University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (9)

Bardocci A, Lofoco G, Perdicaro S, Ciucci F, Manna L. Lidocaine 2% gel versus lidocaine 4% unpreserved drops for topical anesthesia in cataract surgery: a randomized controlled trial. Ophthalmology. 2003 Jan;110(1):144-9. — View Citation

Busbee BG, Alam A, Reichel E. Lidocaine hydrochloride gel for ocular anesthesia: results of a prospective, randomized study. Ophthalmic Surg Lasers Imaging. 2008 Sep-Oct;39(5):386-90. — View Citation

Caudle LE, Williams KA, Pesudovs K. The Eye Sensation Scale: an ophthalmic pain severity measure. Optom Vis Sci. 2007 Aug;84(8):752-62. — 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

Cintra LP, Lucena LR, Da Silva JA, Costa RA, Scott IU, Jorge R. Comparative study of analgesic effectiveness using three different anesthetic techniques for intravitreal injection of bevacizumab. Ophthalmic Surg Lasers Imaging. 2009 Jan-Feb;40(1):13-8. — View Citation

Friedman SM, Margo CE. Topical gel vs subconjunctival lidocaine for intravitreous injection: a randomized clinical trial. Am J Ophthalmol. 2006 Nov;142(5):887-8. — View Citation

Kozak I, Cheng L, Freeman WR. Lidocaine gel anesthesia for intravitreal drug administration. Retina. 2005 Dec;25(8):994-8. — View Citation

Page MA, Fraunfelder FW. Safety, efficacy, and patient acceptability of lidocaine hydrochloride ophthalmic gel as a topical ocular anesthetic for use in ophthalmic procedures. Clin Ophthalmol. 2009;3:601-9. Epub 2009 Nov 2. — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection	Discomfort according to the Eye Sensation Scale: 1-none, 2- mild, 3- moderate, 4- severe, 5- extremely severe; Patient satisfaction scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5= extremely satisfied	immediately after injection, 1- hour later, and next day	No
Secondary	Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg	intraocular pressure (IOP) was measured immediately after the injection, and at 5, 10, and 15 minutes after the injection (until it was 30 mmHg or below). Prior to injection IOP and post-injection IOP were compared to find the IOP change after injection.	immediately after injection, at 5, 10, 15 minutes	Yes
Secondary	Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage	Presence of corneal staining after the injection: Quadrants of fluorescein staining: 0 1 2 3 4; Density of staining: 0- None 1- Mild 2- Moderate 3- Severe 4- corneal abrasion; Size of subconjunctival hemorrhage: in clock hours	within 10 minutes of the injection	Yes