Study of Two-step Anesthesia in Posterior Vitrectomy

Aier School of Ophthalmology, Central South University

Status: Unknown

Conditions: Anesthesia, Local

Treatments: Procedure: retrobulbar anesthesia; Procedure: peribulbar anesthesia; Procedure: two step anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03577574

SHIRB2018013

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

retrobulbar anesthesia group

Active Comparator group

Description:

2% lidocaine 4ml injected into retrobulbar space

Treatment:

Procedure: retrobulbar anesthesia

peribulbar anesthesia group

Active Comparator group

Description:

2% lidocaine 4 to 8ml injected into peribulbar space

Treatment:

Procedure: peribulbar anesthesia

two step anesthesia group

Experimental group

Description:

conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times + 2% lidocaine 0.6 to 0.8ml subconjunctival injection

Treatment:

Procedure: two step anesthesia