Vibration-Assisted Anaesthesia

This study has been completed.

Sponsor:

Information provided by:

University of British Columbia

ClinicalTrials.gov Identifier:

NCT00793988

First received: November 18, 2008

Last updated: April 2, 2009

Last verified: April 2009

History of Changes

Purpose

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
Dermatochalasis Blepharoptosis	Procedure: Vibration-assisted anaesthesia Procedure: Switched-off vibrating device	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: cutis laxa

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

Patients' verbal pain scores will be elicited and documented immediately by the oculoplastic fellow. [ Time Frame: Immediately ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	October 2008
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Show Detailed Description

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793988

Locations

Canada, British Columbia
Eye Care Centre (operating rooms)
Vancouver, British Columbia, Canada, V5Z 3N9

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:

Peter Dolman, MD

University of British Columbia

More Information

No publications provided

Responsible Party:	Peter Dolman MD, University of British Columbia
ClinicalTrials.gov Identifier:	NCT00793988 History of Changes
Other Study ID Numbers:	H08-02244
Study First Received:	November 18, 2008
Last Updated:	April 2, 2009
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

vibration
local anaesthesia
ptosis surgery

blepharoplasty
Upper eyelid surgery
dermatochalasis +/- blepharoptosis

Additional relevant MeSH terms:

Blepharoptosis
Cutis Laxa
Eyelid Diseases
Eye Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases

Skin Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013

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