Efficacy of Subtenon's Block With Olive Tipped Cannula

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by King Khaled Eye Specialist Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
King Khaled Eye Specialist Hospital
ClinicalTrials.gov Identifier:
NCT01019018
First received: November 17, 2009
Last updated: November 24, 2009
Last verified: November 2009
  Purpose

The purpose of this study is to compare the efficacy of olive tip cannula to the standard Steven's cannula in performing subtenon's anesthesia for patients undergoing cataract surgery.


Condition Intervention Phase
Cataract
Device: subtenon block
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Health Services Research
Official Title: Efficacy of Subtenon Anesthesia With Olive Tipped Cannula: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by King Khaled Eye Specialist Hospital:

Primary Outcome Measures:
  • Measurement of Akinesia score [ Time Frame: 10 minutes after the block ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surgeon satisfactions score [ Time Frame: At the end of the procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2009
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stevens cannula
Subtenon with stevens cannula
Device: subtenon block
subtenon block with stevens cannula
Experimental: Olive tip
Olive tip group
Device: subtenon block
subtenon block with Olive tip cannula cannula

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient undergoing cataract extraction procedure under local anesthesia

Exclusion Criteria:

  • Patients allergic to local anesthetic solutions.
  • Presence local sepsis,
  • Previous retinal or strabismus surgery in the same eye.
  • Orbital abnormalities
  • Previous subtenon's block in the same quadrant.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019018

Contacts
Contact: Waleed Riad, MD,AB,SB,KSUF 0096614821234 ext 3215 waleed_riad@yahoo.com

Locations
Saudi Arabia
king Khaled Eye Specialist hospital Recruiting
Riyadh, Saudi Arabia, 11462
Contact: Waleed Riad, MD, SB,AB,KSUF    0096614821234 ext 3215    waleed_riad@yahoo.com   
Sponsors and Collaborators
King Khaled Eye Specialist Hospital
  More Information

No publications provided

Responsible Party: Waleed Riad, King khaled Eye specialist hospital
ClinicalTrials.gov Identifier: NCT01019018     History of Changes
Other Study ID Numbers: RP 0928
Study First Received: November 17, 2009
Last Updated: November 24, 2009
Health Authority: Saudi Arabia: Ministry of Health

Keywords provided by King Khaled Eye Specialist Hospital:
subtenon block

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 20, 2014