Adult, Age-Related Ptosis, Anesthetics, Local, Blepharoplasty, Humans, Lidocaine, Ophthalmologic Surgical Procedure, Surgery, Vibration
Conditions
Keywords
Study, Crossover, Pain Measurement, Prospective Study
Brief summary
To compare the efficacy of topical tapping vs vibration in lowering pain scores for periocular anesthesia injections.
Detailed description
Participants will be selected from 3 local oculoplastics surgeons' procedural slates during the study period. Eligible participants are those who will be undergoing bilateral eye procedures. They will be randomized into one of two groups: Group A will receive tapping on their forehead for their first eye injection of local anesthesia, and then vibration to their forehead for the second eye. Group B will receive the reverse. Pain scores will be aggregated and an average taken to help determine which method is superior. The vibration assist device (variety of facial massagers are available on Amazon for roughly $16-20CDN) is being considered in addition to the current standard of tapping or no tactile distraction at all during the injection of local anesthetic. The 11-point pain Visual Analog Scale will be used to help grade pain experience after each eye is frozen. To help qualify, if there is a difference, the patient will be asked if they felt one technique was better than the other by a little, quite a bit, or a lot.
Interventions
DEVICEVibration
Vibration Assist Device, held to the forehead
OTHERTapping
Tapping on the forehead
Sponsors
Winnipeg Regional Health Authority
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
The participant and surgeon was not made aware of which intervention the participant would receive first until the time of the procedure. Randomization was made at the time of the procedure.
Intervention model description
Each patient will receive both interventions and serve as their own comparator.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients undergoing elective bilateral eye procedures such as blepharoplasty
Exclusion criteria
* previous eyelid surgery * inability to give consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Reduction in Tapping vs Vibration distraction techniques in peri-ocular local anesthesia | Immediately after both eyes receive local anesthetic | How effective each intervention was in reducing the pain of peri-ocular local anesthesia, as graded on an 11-point Visual Analog Pain Scale (from 0-10 where 10/10 pain is the worst and 0/10 pain is no pain at all) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Pain Reduction | Immediately after both eye receive local anesthetic | If there was a difference, subjective qualitative grading of how much difference: a little bit, quite a bit, or a lot |
Countries
Canada
Outcome results
None listed