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A prospective, randomised, single-masked comparison of local anaesthetic approaches including topical anesthesia combined sub-conjunctival anesthesia (two-step anesthesia) for intravitreal injection #TAIVI# vs topical anesthesia
Purpose: Patient pain for intravitreal injection is evaluated between topical anesthesia combined sub-conjunctival anesthesia (two-step anesthesia) and topical anesthesia.
Methods: This prospective, randomized, single-blinded clinical trail is conducted at Shanghai Aier Eye Hospital. Selected group of 60 patients will be randomized divided into 2 groups and underwent intravitreal injection of antiangiogenic agents and steroids. Group1 uses two-step anesthesia , whereas Group 2 uses topical anesthesia. A 5-point Visual Analogue Pain Scale is used to assess patients' pain score and surgeon's ease while operating. Any complications therefore will be made note of.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| topical anesthesia group | Active Comparator | conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times |
|
| two step anesthesia group | Experimental | conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times + 2% lidocaine 0.2 ml subconjunctival injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two step anesthesia | Procedure | conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times + 2% lidocaine 0.2 ml subconjunctival injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores | 5-point Visual Analogue Pain Scale (VAPS): Grade 1: No pain or discomfort; Grade 2: mild pain or discomfort; Grade 3: moderate pain or discomfort; Grade 4: severe pain or discomfort | During surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeon's ease | Grade 1: No discomfort; Grade 2: mild discomfort; Grade 3: moderate discomfort; Grade 4: severe discomfort | During surgery |
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Inclusion Criteria:
Neovascular age-related macular degeneration (wAMD); Pathologic myopia with choroidal neovascularisation (PM-CNV); Diabetic macular edema (DME); Retinal vein occlusion with macular edema (RVO-ME); Other diseases: uveitis with macular edema or choroidal neovascularisation.
Exclusion Criteria:
Communication problems; Allergy to amide-type local anaesthetic agents; History of vitreoretinal surgery or orbital surgery; Orbital deformity; With episcleral adjunct surgery; Trauma; Keratitis; Conjunctivitis.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong Lin | Contact | +86-13080707858 | lindong_1219@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Wensheng Li | Shanghai Aier Eye Hosptial | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Aier Eye Hospital | Recruiting | Shanghai | 200336 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28680703 | Result | Shiroma HF, Takaschima AKK, Farah ME, Hofling-Lima AL, de Luca Canto G, Benedetti RH, Rodrigues EB. Patient pain during intravitreal injections under topical anesthesia: a systematic review. Int J Retina Vitreous. 2017 Jul 3;3:23. doi: 10.1186/s40942-017-0076-9. eCollection 2017. | |
| 21102369 | Result | Blaha GR, Tilton EP, Barouch FC, Marx JL. Randomized trial of anesthetic methods for intravitreal injections. Retina. 2011 Mar;31(3):535-9. doi: 10.1097/IAE.0b013e3181eac724. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000758 | Anesthesia |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
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| topical anesthesia | Procedure | conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times |
|
| 29770638 | Result | Shin SH, Park SP, Kim YK. Factors Associated with Pain Following Intravitreal Injections. Korean J Ophthalmol. 2018 Jun;32(3):196-203. doi: 10.3341/kjo.2017.0081. Epub 2018 May 15. |
| 29769650 | Result | Nguyen NCI, Fabro F, Ambresin A, Ezziat S, Bergin C, Mazzocato C, Mantel I. Factors associated with pain during intravitreal injection of anti-vascular endothelial growth factor. Eye (Lond). 2018 Sep;32(9):1544-1546. doi: 10.1038/s41433-018-0126-z. Epub 2018 May 17. No abstract available. |
| 23330822 | Result | Sanabria MR, Montero JA, Losada MV, Fernandez-Munoz M, Galindo A, Fernandez I, Coco RM, Sampedro A. Ocular pain after intravitreal injection. Curr Eye Res. 2013 Feb;38(2):278-82. doi: 10.3109/02713683.2012.758290. Epub 2013 Jan 18. |