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Study of Two-step Anesthesia in Posterior Vitrectomy

A

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

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

Trial contacts and locations

1

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Central trial contact

Hua Fan

Data sourced from clinicaltrials.gov

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