Pain
Conditions
Keywords
pain, discomfort, anesthetic drugs, topical drug administration, injections, intraocular, lidocaine, intraocular pressure, keratopathy
Brief 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.
Detailed 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.
Interventions
DRUG4% 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.
DRUG3.5% 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.
Sponsors
University of Miami
Bascom Palmer Eye Institute
Miami VA Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection | immediately after injection, 1- hour later, and next day | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg | immediately after injection, at 5, 10, 15 minutes | 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. |
| Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage | within 10 minutes of the injection | 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 |
Countries
United States
Participant flow
Recruitment details
Miami VA Medical Center retina injection clinic; patients needing frequent intravitreal injections of ranibizumab were approached and recruited between April 2010 and March 2011
Pre-assignment details
Patients were randomized upon recruitment and received the first anesthetic method on the day of recruitment, no wash out or transitional periods were necessary
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Each participant was randomly assigned to receive either anesthetic preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | enrolled in another VA study | 0 | 1 |
| Overall Study | unable to survey by telephone | 0 | 1 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 44 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age Continuous | 74 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 53 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 53 | 0 / 53 |
| serious Total, serious adverse events | 1 / 53 | 1 / 53 |
Outcome results
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
Time frame: immediately after injection, 1- hour later, and next day
Population: all 50 patients who completed the study were included in the analysis, each patient received both anesthetic preparations prior to two consecutive (if unilateral disease) intravitreal injections on consecutive visits or in fellow eyes (if bilaterla disease) on the same day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 4% Liquid Lidocaine Method | Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection | Discomfort during anesthetic preparation | 2.1 units on a scale | Standard Deviation 1.1 |
| 4% Liquid Lidocaine Method | Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection | Discomfort during needle penetration | 1.7 units on a scale | Standard Deviation 0.9 |
| 4% Liquid Lidocaine Method | Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection | Satisfaction with entire prep and injection | 4.3 units on a scale | Standard Deviation 1 |
| 4% Liquid Lidocaine Method | Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection | Discomfort 1 h after injection | 2.4 units on a scale | Standard Deviation 1 |
| 4% Liquid Lidocaine Method | Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection | Discomfort day after injection | 1.8 units on a scale | Standard Deviation 0.8 |
| 4% Liquid Lidocaine Method | Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection | Next day satisfaction with injection | 4.3 units on a scale | Standard Deviation 1 |
| 3.5% Ophthalmic Lidocaine Gel | Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection | Discomfort day after injection | 1.6 units on a scale | Standard Deviation 0.8 |
| 3.5% Ophthalmic Lidocaine Gel | Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection | Discomfort during anesthetic preparation | 2.09 units on a scale | Standard Deviation 0.8 |
| 3.5% Ophthalmic Lidocaine Gel | Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection | Discomfort 1 h after injection | 2.1 units on a scale | Standard Deviation 1.1 |
| 3.5% Ophthalmic Lidocaine Gel | Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection | Discomfort during needle penetration | 2.0 units on a scale | Standard Deviation 0.9 |
| 3.5% Ophthalmic Lidocaine Gel | Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection | Next day satisfaction with injection | 4.3 units on a scale | Standard Deviation 0.9 |
| 3.5% Ophthalmic Lidocaine Gel | Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection | Satisfaction with entire prep and injection | 4.5 units on a scale | Standard Deviation 0.8 |
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.
Time frame: immediately after injection, at 5, 10, 15 minutes
Population: 48 participants were included in each arm, i.e. each participant received both methods, one eye twice if unilateral or both eyes if bilateral disease were randomily assigned to alternate prep on consecutive or same visit respectively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 4% Liquid Lidocaine Method | Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg | baseline IOP before injection | 15.5 mmHg | Standard Deviation 3.3 |
| 4% Liquid Lidocaine Method | Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg | IOP change after 0.05 cc injection | 25.7 mmHg | Standard Deviation 9.2 |
| 3.5% Ophthalmic Lidocaine Gel | Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg | baseline IOP before injection | 15.9 mmHg | Standard Deviation 3 |
| 3.5% Ophthalmic Lidocaine Gel | Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg | IOP change after 0.05 cc injection | 30.9 mmHg | Standard Deviation 9.9 |
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
Time frame: within 10 minutes of the injection
Population: all eyes for which data were available were included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 4% Liquid Lidocaine Method | Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage | Corneal fluorescein staining | 3.0 units on a scale | Standard Deviation 1 |
| 4% Liquid Lidocaine Method | Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage | Density of corneal staining | 1.9 units on a scale | Standard Deviation 0.7 |
| 3.5% Ophthalmic Lidocaine Gel | Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage | Corneal fluorescein staining | 2.3 units on a scale | Standard Deviation 1.3 |
| 3.5% Ophthalmic Lidocaine Gel | Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage | Density of corneal staining | 1.3 units on a scale | Standard Deviation 0.7 |