Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Two-step Anesthesia in Posterior Vitrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03577574
Recruitment Status : Unknown
Verified May 2018 by Aier School of Ophthalmology, Central South University.
Recruitment status was:  Recruiting
First Posted : July 5, 2018
Last Update Posted : July 5, 2018
Sponsor:
Information provided by (Responsible Party):
Aier School of Ophthalmology, Central South University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : August 2, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2019
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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;


Secondary Outcome Measures :
  1. surgeon's ease [ Time Frame: During surgery ]
    Grade 1: No discomfort; Grade 2: mild discomfort; Grade 3: moderate discomfort; Grade 4: severe discomfort;


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03577574


Contacts
Layout table for location contacts
Contact: Hua Fan +8618988761617 fanhua1116@163.com

Locations
Layout table for location information
China
Wensheng Li Recruiting
Shanghai, China
Contact: Hua Fan    +8618988761617    fanhua1116@163.com   
Sponsors and Collaborators
Aier School of Ophthalmology, Central South University
Investigators
Layout table for investigator information
Study Director: Wensheng Li Shanghai Aier Eye Hosptial
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Aier School of Ophthalmology, Central South University
ClinicalTrials.gov Identifier: NCT03577574    
Other Study ID Numbers: SHIRB2018013
First Posted: July 5, 2018    Key Record Dates
Last Update Posted: July 5, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs