Study of Two-step Anesthesia in Posterior Vitrectomy

• Sponsor: Aier School of Ophthalmology, Central South University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03577574
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 18

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Local	Procedure: retrobulbar anesthesia; Procedure: peribulbar anesthesia; Procedure: two step anesthesia	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: A Prospective, Randomised, Single-masked Comparison of Retrobulbar Anesthesia, Peribulbar Anesthesia and Topical Combined Subconjunctival(Two-step) Anesthesia in Posterior Vitrectomy
• Anticipated Study Start Date: Aug 2, 2018
• Anticipated Primary Completion Date: Jan 1, 2019
• Anticipated Study Completion Date: Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: retrobulbar anesthesia group 2% lidocaine 4ml injected into retrobulbar space	Procedure: retrobulbar anesthesia; 2% lidocaine 4ml injected into retrobulbar space
Active Comparator: peribulbar anesthesia group 2% lidocaine 4 to 8ml injected into peribulbar space	Procedure: peribulbar anesthesia; 2% lidocaine 4 to 8ml injected into peribulbar space
Experimental: 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	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

Outcome Measures

Primary Outcome Measures

1. 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

1. surgeon's ease [During surgery]

   Grade 1: No discomfort; Grade 2: mild discomfort; Grade 3: moderate discomfort; Grade 4: severe discomfort;

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wensheng Li	Shanghai		China

Sponsors and Collaborators

• Aier School of Ophthalmology, Central South University

Investigators

• Study Director: Wensheng Li, Shanghai Aier Eye Hosptial

Study Documents (Full-Text)

None provided.

More Information

Publications

• Bahçecioglu H, Unal M, Artunay O, Rasier R, Sarici A. Posterior vitrectomy under topical anesthesia. Can J Ophthalmol. 2007 Apr;42(2):272-7.
• Chan WM, Loo AV, Tam BS. Topical anesthesia in posterior vitrectomy. Retina. 2000;20(5):563-5.
• 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.
• 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.

• Responsible Party: Aier School of Ophthalmology, Central South University
• ClinicalTrials.gov Identifier: NCT03577574
• Other Study ID Numbers: SHIRB2018013
• First Posted: Jul 5, 2018
• Last Update Posted: Jul 5, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anesthetics

Study Results

No Results Posted as of Jul 5, 2018