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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 minimally invasive vitrectomy（TAMIV）vs peribulbar block vs retrobulbar block
Purpose: topical anesthesia combined sub-conjunctival anesthesia(two-step anesthesia) for minimally invasive vitrectomy Methods: This prospective, randomized, single-blinded clinical trail is conducted at Shanghai Aier Eye Hospital. Selected group of 60 patients with retinal-vitreous diseases will be randomized divided into 3 groups and underwent 25-gauge vitrectomy. Group1 uses two-step anesthesia , whereas Group 2 uses retrobulbar anesthesia, group 3 uses peribulbar 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 |
|---|---|---|---|
| retrobulbar anesthesia group | Active Comparator | 2% lidocaine 4ml injected into retrobulbar space |
|
| peribulbar anesthesia group | Active Comparator | 2% lidocaine 4 to 8ml injected into peribulbar space |
|
| two step anesthesia group | Experimental | conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times + 2% lidocaine 0.6 to 0.8ml subconjunctival injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| retrobulbar anesthesia | Procedure | 2% lidocaine 4ml injected into retrobulbar space |
|
| 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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hua Fan | Contact | +8618988761617 | fanhua1116@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wensheng Li | Shanghai Aier Eye Hosptial | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wensheng Li | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11039443 | Background | Chan WM, Loo AV, Tam BS. Topical anesthesia in posterior vitrectomy. Retina. 2000;20(5):563-5. doi: 10.1097/00006982-200005000-00029. No abstract available. | |
| 17392852 | Background | Bahcecioglu H, Unal M, Artunay O, Rasier R, Sarici A. Posterior vitrectomy under topical anesthesia. Can J Ophthalmol. 2007 Apr;42(2):272-7. |
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| peribulbar anesthesia | Procedure | 2% lidocaine 4 to 8ml injected into peribulbar space |
|
| two step anesthesia | Procedure | conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times + 2% lidocaine 0.6 to 0.8ml subconjunctival injection |
|
| 20494757 | Background | Schrader WF, Schargus M, Schneider E, Josifova T. Risks and sequelae of scleral perforation during peribulbar or retrobulbar anesthesia. J Cataract Refract Surg. 2010 Jun;36(6):885-9. doi: 10.1016/j.jcrs.2009.12.029. |
| 26800356 | Background | Takaschima A, Marchioro P, Sakae TM, Porporatti AL, Mezzomo LA, De Luca Canto G. Risk of Hemorrhage during Needle-Based Ophthalmic Regional Anesthesia in Patients Taking Antithrombotics: A Systematic Review. PLoS One. 2016 Jan 22;11(1):e0147227. doi: 10.1371/journal.pone.0147227. eCollection 2016. |