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Vibration-Assisted Anaesthesia

NCT00793988 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2009-04-03

No results posted yet for this study

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.

Conditions

  • Dermatochalasis
  • Blepharoptosis

Interventions

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.

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.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Peter Dolman, MD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00793988 on ClinicalTrials.gov