Study of Two-step Anesthesia in Posterior Vitrectomy

July 2, 2018 updated by: Aier School of Ophthalmology, Central South University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Wensheng Li
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain scores
Time Frame: 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;
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgeon's ease
Time Frame: During surgery
Grade 1: No discomfort; Grade 2: mild discomfort; Grade 3: moderate discomfort; Grade 4: severe discomfort;
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aier School of Ophthalmology, Central South University

Investigators

  • Study Director: Wensheng Li, Shanghai Aier Eye Hosptial

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 2, 2018

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

May 28, 2018

First Submitted That Met QC Criteria

July 2, 2018

First Posted (Actual)

July 5, 2018

Study Record Updates

Last Update Posted (Actual)

July 5, 2018

Last Update Submitted That Met QC Criteria

July 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHIRB2018013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anesthesia, Local

Clinical Trials on retrobulbar anesthesia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe