Clinical trial NCT06355817: Distraction Techniques in Periocular Anesthesia: Tapping vs Vibration
Official title: Distraction Techniques in Periocular Anesthesia: Tapping vs Vibration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthetics, Local
Blepharoplasty
Age-Related Ptosis
Adult
Humans
Lidocaine
Ophthalmologic Surgical Procedure
Vibration
Surgery
Keywords: Study, Crossover
Pain Measurement
Prospective Study
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Winnipeg Regional Health Authority
First posted: 2024-04-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each patient will receive both interventions and serve as their own comparator.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* adult patients undergoing elective bilateral eye procedures such as blepharoplasty

Exclusion Criteria:

* previous eyelid surgery
* inability to give consent

Primary outcomes:
measure: Pain Reduction in Tapping vs Vibration distraction techniques in peri-ocular local anesthesia
timeFrame: Immediately after both eyes receive local anesthetic
Secondary outcomes:
measure: Difference in Pain Reduction
timeFrame: Immediately after both eye receive local anesthetic
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Misericordia Health Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba, Dept of Ophthalmology
name: Yen Minh Cung, MD
role: PRINCIPAL_INVESTIGATOR
References:
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