Intravitreal Injection Anesthesia - Comparison of Different Topical Agents

Intravitreal Injection Anesthesia - Comparison of Different Topical Agents.

Patients with neovascular age-related macular degeneration (AMD) scheduled to receive intravitreal (IVT) Ranibizumab injection will be randomized to receive one of three topical anesthetics: (1) tetracaine drop (gtt) + lidocaine pledget to the injection site for 10 seconds (2) tetracaine gtt alone and (3) cocaine gtt alone. A questionnaire will be conducted immediately after and 15 minutes after the injection, to assess for pain.

Study Overview

• Status: Completed
• Conditions: Age-Related Macular Degeneration (AMD)
• Intervention / Treatment: Drug: Tetracaine; Drug: Lidocaine; Drug: Cocaine

Detailed Description

All patients scheduled to receive intravitreal Ranibizumab for the treatment of neovascular AMD will be evaluated for inclusion into the study. After a positive evaluation, the study will be explained to the patient, the Letter of Explanation reviewed with the patient and informed consent approved if patient agrees to participate. Demographic data of sex and age will be recorded. As well the number of previous intravitreal injections will be recorded ( none, 2 - 5 and > 5 ). A nurse will then proceed to select an opaque envelope from a box of identical envelopes. The envelope will contain the topical anesthetic agent to be used. The randomization code linking each patient to their anesthetic will be stored in a secure location, and only accessed at the completion of the trial. The anesthetic procedure will be performed by someone other than the surgeon who will perform the IVT injection. After a minute of the anesthetic application, the surgeon, blinded to the anesthetic intervention, will perform the IVT injection of Ranibizumab. Immediately following the injection, a blinded observer will first explain the Pain Questionnaire, and then conduct it. Also at this time, the physician who performed the injection will complete the Wong-Baker Pain Questionnaire. The patient will then be asked to wait in a room for an additional 15 minutes, where the same observer will return and the Pain Questionnaire will be conducted a second time.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • Ivey Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age greater than 50
2. Scheduled to receive Ranibizumab for neovascular AMD

Exclusion Criteria:

1. History of pars plana vitrectomy
2. Any major surgery within the prior 28 days, or one planned within next 6 months
3. History of thromboembolic event
4. Previous known allergic response to topical anesthetic(s) (lidocaine, tetracaine, cocaine)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Tetracaine gtt; Pre-Intravitreal injection - 1 gtt Tetracaine topically	Drug: Tetracaine; 1 gtt
ACTIVE_COMPARATOR: Tetraciane gtt + Lidocaine pledget; 1 gtt Tetracaine pre-IVT injection + application Lidocaine pledget to injection site	Drug: Lidocaine; Lidocaine soaked pledget
ACTIVE_COMPARATOR: Cocaine gtt alone; 1 gtt pre-IVT injection	Drug: Cocaine; 1 gtt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To elucidate the most effective topical agent for intravitreal injections.	Patients will measure pain by the use of a Visual Analog Scale.	Pain scores reported immediately after intravitreal injection.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To elucidate the most effective topical agent for intravitreal injections.	Patients will measure pain by the use of a Visual Analog Scale.	Pain scores reported 15 minutes after intravitreal injection.

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Thomas G Sheidow, MD, FRCSC, Ivey Eye Institute, St. Joseph's Health Care

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ACTUAL): November 1, 2009
• Study Completion (ACTUAL): November 1, 2009

Study Registration Dates

• First Submitted: October 6, 2010
• First Submitted That Met QC Criteria: October 19, 2010
• First Posted (ESTIMATE): October 20, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): April 19, 2012
• Last Update Submitted That Met QC Criteria: April 17, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: AMD; Anesthesia; Intravitreal Injection
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Dopamine Uptake Inhibitors; Vasoconstrictor Agents; Lidocaine; Tetracaine; Cocaine
• Other Study ID Numbers: R-09-415; 16454 (OTHER: REB)