Clinical trial NCT03577574: Study of Two-step Anesthesia in Posterior Vitrectomy
Official title: A Prospective, Randomised, Single-masked Comparison of Retrobulbar Anesthesia, Peribulbar Anesthesia and Topical Combined Subconjunctival(Two-step) Anesthesia in Posterior Vitrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia, Local
Lead sponsor: Aier School of Ophthalmology, Central South University
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Proliferative diabetic retinopathy (PDR);
* Vitreous haemorrhage (VH);
* Retinal detachment (RD);
* Retinal vein occlusion(RVO);
* Other diseases (idiopathic macular hole, macular pucker and high myopic maculopathy);
* Silicone oil-filled eye.

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 and active uveitis.

Primary outcomes:
measure: pain scores
timeFrame: During surgery
Secondary outcomes:
measure: surgeon's ease
timeFrame: During surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Wensheng Li
Study officials:
affiliation: Shanghai Aier Eye Hosptial
name: Wensheng Li
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Bahcecioglu H, Unal M, Artunay O, Rasier R, Sarici A. Posterior vitrectomy under topical anesthesia. Can J Ophthalmol. 2007 Apr;42(2):272-7.
citation: 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.
citation: 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.