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Efficacy of Subtenon's Block With Olive Tipped Cannula

Primary Purpose

Cataract

Status

Completed

Phase

Phase 4

Locations

Saudi Arabia

Study Type

Interventional

Intervention

subtenon block

About this trial

This is an interventional health services research trial for Cataract focused on measuring subtenon block

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

king Khaled Eye Specialist hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Stevens cannula

Olive tip

Arm Description

Subtenon with stevens cannula

Olive tip group

Outcomes

Primary Outcome Measures

Measurement of Akinesia score

Secondary Outcome Measures

Surgeon satisfactions score

Full Information

NCT ID

NCT01019018

First Posted

November 17, 2009

Last Updated

October 14, 2021

Sponsor

King Khaled Eye Specialist Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01019018

Brief Title

Efficacy of Subtenon's Block With Olive Tipped Cannula

Official Title

Efficacy of Subtenon Anesthesia With Olive Tipped Cannula: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

November 2009 (Actual)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

October 2011 (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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

Keywords

subtenon block

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stevens cannula

Arm Type

Active Comparator

Arm Description

Subtenon with stevens cannula

Arm Title

Olive tip

Arm Type

Experimental

Arm Description

Olive tip group

Intervention Type

Device

Intervention Name(s)

subtenon block

Intervention Description

subtenon block with stevens cannula

Intervention Type

Device

Intervention Name(s)

subtenon block

Intervention Description

subtenon block with Olive tip cannula cannula

Primary Outcome Measure Information:

Title

Measurement of Akinesia score

Time Frame

10 minutes after the block

Secondary Outcome Measure Information:

Title

Surgeon satisfactions score

Time Frame

At the end of the procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

king Khaled Eye Specialist hospital

City

Riyadh

ZIP/Postal Code

11462

Country

Saudi Arabia

12. IPD Sharing Statement

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Efficacy of Subtenon's Block With Olive Tipped Cannula

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