We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Vibration-Assisted Anaesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00793988
Recruitment Status : Completed
First Posted : November 19, 2008
Last Update Posted : April 3, 2009
Information provided by:
University of British Columbia

Brief Summary:
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 or disease Intervention/treatment Phase
Dermatochalasis Blepharoptosis Procedure: Vibration-assisted anaesthesia Procedure: Switched-off vibrating device Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Patients' verbal pain scores will be elicited and documented immediately by the oculoplastic fellow. [ Time Frame: Immediately ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Adult patients (> 16 years) undergoing bilateral upper eyelid surgery under local anaesthetic who have given fully informed consent to be in the trial

Exclusion Criteria:

  • Age less than 16 years
  • Previous upper eyelid surgery

Information from the National Library of Medicine

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

Layout table for location information
Canada, British Columbia
Eye Care Centre (operating rooms)
Vancouver, British Columbia, Canada, V5Z 3N9
Sponsors and Collaborators
University of British Columbia
Layout table for investigator information
Principal Investigator: Peter Dolman, MD University of British Columbia
Layout table for additonal information
Responsible Party: Peter Dolman MD, University of British Columbia
ClinicalTrials.gov Identifier: NCT00793988    
Other Study ID Numbers: H08-02244
First Posted: November 19, 2008    Key Record Dates
Last Update Posted: April 3, 2009
Last Verified: April 2009
Keywords provided by University of British Columbia:
local anaesthesia
ptosis surgery
Upper eyelid surgery
dermatochalasis +/- blepharoptosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Cutis Laxa
Eyelid Diseases
Eye Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases
Central Nervous System Depressants
Physiological Effects of Drugs