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|ClinicalTrials.gov Identifier: NCT00793988|
Recruitment Status : Completed
First Posted : November 19, 2008
Last Update Posted : April 3, 2009
|Condition or disease||Intervention/treatment||Phase|
|Dermatochalasis Blepharoptosis||Procedure: Vibration-assisted anaesthesia Procedure: Switched-off vibrating device||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vibration-Assisted Anaesthesia: A Randomised Controlled Trial to Investigate Whether Vibration Reduces the Pain of Anaesthetic Injection in Eyelid Surgery|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||April 2009|
Active Comparator: 1
Group receiving vibration-assisted anaesthesia
Procedure: Vibration-assisted anaesthesia
All anaesthetic injections will consist of xylocaine 1% with 1:100,000 adrenaline and will be administered through a short 30 Gauge needle at a constant slow speed at multiple (6-7) sites along the upper lid by a single oculoplastic consultant.
The vibration device and placebo will be operated by a single oculoplastics fellow. The vibrating device / placebo will be placed on the middle of the forehead 1 cm above the mid-brow point 1 second before the anaesthetic injection is commenced. It will be lifted off the skin every time the injection needle exits the skin and it will be replaced on the same point 1 second before the needle reenters the skin at a new injection site.
Placebo Comparator: 2
Group receiving switched-off vibrating device
Procedure: Switched-off vibrating device
The placebo consists of a switched-off vibrating device applied to the test site and a second identical switched-on vibrating device held close (but not touching) the first, which will therefore make the same sound. Care will be taken to ensure that the devices are out of the participants' view. The test and placebo will be randomly assigned to either the first or second eyelid; the right eyelid will be injected first in all patients, as is our routine practice.
- Patients' verbal pain scores will be elicited and documented immediately by the oculoplastic fellow. [ Time Frame: Immediately ]
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): NCT00793988
|Canada, British Columbia|
|Eye Care Centre (operating rooms)|
|Vancouver, British Columbia, Canada, V5Z 3N9|
|Principal Investigator:||Peter Dolman, MD||University of British Columbia|