Back to resultsAdjunctive Local Application of Lidocaine During Scleral Buckling Under General Anesthesia
Primary Purpose
Retinal Detachment
Status
Unknown status
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Detachment
Eligibility Criteria
Inclusion Criteria:
- Retinal detachment
- Retinal tear less than 3 hour clock
Exclusion Criteria:
- Vitreous hemorrhage
- Proliferative vitreoretinopathy
Sites / Locations
- Isfahan University of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
lidocaine
Arm Description
Outcomes
Primary Outcome Measures
intraoperative heart rate measurement
decrease in pain and nausea,vomiting after surgery
decrease in ocr after application of topical lidocaine
postoperative nausea and vommitting
postoperative pain
Secondary Outcome Measures
Full Information
NCT ID
NCT01417572
First Posted
August 9, 2011
Last Updated
August 15, 2011
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01417572
Brief Title
Adjunctive Local Application of Lidocaine During Scleral Buckling Under General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of topical lidocaine in scleral buckling surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lidocaine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
lidocaine
Intervention Description
to evaluate the effect of lidocaine on oculocardiac reflex during the surgery
Primary Outcome Measure Information:
Title
intraoperative heart rate measurement
Time Frame
6 month
Title
decrease in pain and nausea,vomiting after surgery
Time Frame
6 month
Title
decrease in ocr after application of topical lidocaine
Time Frame
6 month
Title
postoperative nausea and vommitting
Time Frame
6 month
Title
postoperative pain
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Retinal detachment
Retinal tear less than 3 hour clock
Exclusion Criteria:
Vitreous hemorrhage
Proliferative vitreoretinopathy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amin Masjedi, MD
Phone
+983112211915
Email
Masjedi1827@gmail.com
Facility Information:
Facility Name
Isfahan University of Medical Sciences
City
Isfahan
ZIP/Postal Code
7864329800
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
amin masjedi, MD
Phone
+983112211915
Email
Masjedi1827@gmail.com
First Name & Middle Initial & Last Name & Degree
Amin Masjedi, MD
12. IPD Sharing Statement
Learn more about this trial
Adjunctive Local Application of Lidocaine During Scleral Buckling Under General Anesthesia
We'll reach out to this number within 24 hrs