Study of Two-step Anesthesia in Posterior Vitrectomy

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03577574
• Other study ID #: SHIRB2018013
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: May 2018
• Source: Aier School of Ophthalmology, Central South University
• Contact: Hua Fan
• Phone: +8618988761617
• Email: fanhua1116[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

Procedure:
• retrobulbar anesthesia
2% lidocaine 4ml injected into retrobulbar space
• peribulbar anesthesia
2% lidocaine 4 to 8ml injected into peribulbar space
• 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

Locations

Country	Name	City	State
China	Wensheng Li	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Aier School of Ophthalmology, Central South University

Country where clinical trial is conducted

China, 

References & Publications (4)

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

Chan WM, Loo AV, Tam BS. Topical anesthesia in posterior vitrectomy. Retina. 2000;20(5):563-5. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain scores	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;	During surgery
Secondary	surgeon's ease	Grade 1: No discomfort; Grade 2: mild discomfort; Grade 3: moderate discomfort; Grade 4: severe discomfort;	During surgery