Back to resultsAnesthesia for Pars Plana Vitrectomy (PPV) With Insulin Needle
Primary Purpose
Retinal Disorders
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
needle
needle
Pars Plana Vitrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Disorders focused on measuring Efficiency, Pars, Plana, Vitrectomy
Eligibility Criteria
Inclusion Criteria:
- Adult patients undergoing pars plana vitrectomy under local anesthesia
Exclusion Criteria:
- Patients allergic to local anesthetic solutions
- With local sepsis
- Serious impairment of coagulation
- Orbital abnormalities
- Unable to cooperate in maintaining a relatively motionless supine position
- Who refused the anesthetic technique
Sites / Locations
- King Khaled Eye Specialist hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Control
Block with short needle
Outcomes
Primary Outcome Measures
Efficacy of insulin needle.
Secondary Outcome Measures
Full Information
NCT ID
NCT00735657
First Posted
July 1, 2008
Last Updated
November 21, 2021
Sponsor
King Khaled Eye Specialist Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00735657
Brief Title
Anesthesia for Pars Plana Vitrectomy (PPV) With Insulin Needle
Official Title
Anesthesia for PPV Using Insulin Needle
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Khaled Eye Specialist Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Periocular blockade with 12.5 mm needle is as effective as block with 25 mm needle for patients undergoing Pars Plana Vitrectomy.
Detailed Description
The author wants to see the effect of short needle in patients undergoing retinal surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Disorders
Keywords
Efficiency, Pars, Plana, Vitrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Control
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Block with short needle
Intervention Type
Device
Intervention Name(s)
needle
Other Intervention Name(s)
Peribulbar blockade with standard needle
Intervention Description
Peribulbar blockade with standard (25 mm) needle
Intervention Type
Device
Intervention Name(s)
needle
Other Intervention Name(s)
Peribulbar blockade with short needle
Intervention Description
Peribulbar blockade with short (12.5 mm) needle
Intervention Type
Procedure
Intervention Name(s)
Pars Plana Vitrectomy
Other Intervention Name(s)
Extraconal block
Intervention Description
Peribulbar block
Primary Outcome Measure Information:
Title
Efficacy of insulin needle.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients undergoing pars plana vitrectomy under local anesthesia
Exclusion Criteria:
Patients allergic to local anesthetic solutions
With local sepsis
Serious impairment of coagulation
Orbital abnormalities
Unable to cooperate in maintaining a relatively motionless supine position
Who refused the anesthetic technique
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waleed Riad, MD
Organizational Affiliation
KKESH
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Khaled Eye Specialist hospital
City
Riyadh
ZIP/Postal Code
11462
Country
Saudi Arabia
12. IPD Sharing Statement
Learn more about this trial
Anesthesia for Pars Plana Vitrectomy (PPV) With Insulin Needle
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