Vibration-Assisted Anaesthesia

NCT00793988 | Completed Phase 4

• 1 other identifier: H08-02244
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatochalasis; Blepharoptosis

Keywords

vibration; local anaesthesia; ptosis surgery; blepharoplasty; Upper eyelid surgery; dermatochalasis +/- blepharoptosis

Outcome Measures

Primary Outcomes (1)

• Patients' verbal pain scores will be elicited and documented immediately by the oculoplastic fellow.

  Immediately

Study Arms (2)

1

ACTIVE COMPARATOR

Group receiving vibration-assisted anaesthesia

Procedure: Vibration-assisted anaesthesia

2

PLACEBO COMPARATOR

Group receiving switched-off vibrating device

Procedure: Switched-off vibrating device

Interventions

Vibration-assisted anaesthesia PROCEDURE

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.

1

Switched-off vibrating device PROCEDURE

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.

2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Age less than 16 years
• Previous upper eyelid surgery

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Eye Care Centre (operating rooms)

Vancouver, British Columbia, V5Z 3N9, Canada

Location

MeSH Terms

Conditions

Cutis Laxa; Blepharoptosis

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Eyelid Diseases; Eye Diseases

Study Officials

• Peter Dolman, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 18, 2008
• First Posted: November 19, 2008
• Study Start: October 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 3, 2009

Record last verified: 2009-04

Locations

CA (1)