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Sponsored by: |
University of British Columbia |
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Information provided by: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT00793988 |
Aim of study is to investigate whether a small, non-invasive vibrating device applied to the forehead during local anaesthetic administration reduces the pain of the injection.
Condition | Intervention | Phase |
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Dermatochalasis Blepharoptosis |
Procedure: Vibration-assisted anaesthesia Procedure: Switched-off vibrating device |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Vibration-Assisted Anaesthesia: A Randomised Controlled Trial to Investigate Whether Vibration Reduces the Pain of Anaesthetic Injection in Eyelid Surgery |
Estimated Enrollment: | 80 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Group receiving vibration-assisted anaesthesia
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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. |
2: Placebo Comparator
Group receiving switched-off vibrating device
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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.
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Tessa Fayers, BSc MBChB | 604-345-0343 | tfayers@btinternet.com |
Canada, British Columbia | |
Eye Care Centre (operating rooms) | Recruiting |
Vancouver, British Columbia, Canada, V5Z 3N9 | |
Contact: Tessa Fayers, MBChB 604-345-0343 tfayers@btinternet.com |
Principal Investigator: | Peter Dolman, MD | University of British Columbia |
Responsible Party: | University of British Columbia ( Peter Dolman MD ) |
Study ID Numbers: | H08-02244 |
Study First Received: | November 18, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00793988 |
Health Authority: | Canada: Health Canada |
vibration local anaesthesia ptosis surgery |
blepharoplasty Upper eyelid surgery dermatochalasis +/- blepharoptosis |
Skin Diseases Cutis Laxa Eye Diseases Lidocaine Pain Prolapse Methamphetamine |
Cutis laxa Genetic Diseases, Inborn Connective Tissue Diseases Amphetamine Epinephrine Skin Diseases, Genetic Blepharoptosis |
Eyelid Diseases |