Study of Two-step Anesthesia in Posterior Vitrectomy

NCT ID: NCT03577574

Last Updated: 2018-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-02

Study Completion Date

2019-01-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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retrobulbar anesthesia group

2% lidocaine 4ml injected into retrobulbar space

Group Type ACTIVE_COMPARATOR

retrobulbar anesthesia

Intervention Type PROCEDURE

2% lidocaine 4ml injected into retrobulbar space

peribulbar anesthesia group

2% lidocaine 4 to 8ml injected into peribulbar space

Group Type ACTIVE_COMPARATOR

peribulbar anesthesia

Intervention Type PROCEDURE

2% lidocaine 4 to 8ml injected into peribulbar space

two step anesthesia group

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

Group Type EXPERIMENTAL

two step anesthesia

Intervention Type PROCEDURE

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

Interventions

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retrobulbar anesthesia

2% lidocaine 4ml injected into retrobulbar space

Intervention Type PROCEDURE

peribulbar anesthesia

2% lidocaine 4 to 8ml injected into peribulbar space

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aier School of Ophthalmology, Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wensheng Li

Role: STUDY_DIRECTOR

Shanghai Aier Eye Hosptial

Locations

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Wensheng Li

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hua Fan

Role: CONTACT

+8618988761617

Facility Contacts

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Hua Fan

Role: primary

+8618988761617

References

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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.

Reference Type BACKGROUND
PMID: 11039443 (View on PubMed)

Bahcecioglu H, Unal M, Artunay O, Rasier R, Sarici A. Posterior vitrectomy under topical anesthesia. Can J Ophthalmol. 2007 Apr;42(2):272-7.

Reference Type BACKGROUND
PMID: 17392852 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20494757 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26800356 (View on PubMed)

Other Identifiers

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SHIRB2018013

Identifier Type: -

Identifier Source: org_study_id

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