Study of Two-step Anesthesia in Posterior Vitrectomy

A Prospective, Randomised, Single-masked Comparison of Retrobulbar Anesthesia, Peribulbar Anesthesia and Topical Combined Subconjunctival(Two-step) Anesthesia in Posterior Vitrectomy

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03577574

Enrollment

Registered

2018-07-05

Start date

2018-08-02

Completion date

2019-01-01

Last updated

2018-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local

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.

Interventions

PROCEDUREretrobulbar anesthesia

2% lidocaine 4ml injected into retrobulbar space

PROCEDUREperibulbar anesthesia

2% lidocaine 4 to 8ml injected into peribulbar space

PROCEDUREtwo step anesthesia

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

30 Years to 85 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
pain scores	During surgery	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;

Secondary

Measure	Time frame	Description
surgeon's ease	During surgery	Grade 1: No discomfort; Grade 2: mild discomfort; Grade 3: moderate discomfort; Grade 4: severe discomfort;

Countries

China

Contacts

Primary ContactHua Fan

fanhua1116@163.com+8618988761617

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026