Study of Two-step Anesthesia in Posterior Vitrectomy

Not Applicable

• Conditions: Anesthesia, Local
• Interventions: Procedure: peribulbar anesthesia; Procedure: retrobulbar anesthesia; Procedure: two step anesthesia

• Registration Number: NCT03577574
• Lead Sponsor: Aier School of Ophthalmology, Central South University

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.

Study Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-05-28
• Study First Submitted QC: 2018-07-02
• Last Update Submitted: 2018-07-02
• Study First Posted: 2018-07-05
• Last Update Posted: 2018-07-05
• Study Start: 2018-08-02
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
peribulbar anesthesia group	peribulbar anesthesia	2% lidocaine 4 to 8ml injected into peribulbar space
retrobulbar anesthesia group	retrobulbar anesthesia	2% lidocaine 4ml injected into retrobulbar space
two step anesthesia group	two step anesthesia	conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times + 2% lidocaine 0.6 to 0.8ml subconjunctival injection

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
surgeon's ease	During surgery	Grade 1: No discomfort; Grade 2: mild discomfort; Grade 3: moderate discomfort; Grade 4: severe discomfort;

Trial Locations

Locations (1)

Wensheng Li; 🇨🇳 Shanghai, China