Distraction Techniques in Periocular Anesthesia: Tapping vs Vibration

Not Applicable

Completed

• Conditions: Adult; Vibration; Anesthetics, Local; Surgery; Lidocaine; Blepharoplasty; Age-Related Ptosis; Ophthalmologic Surgical Procedure; Humans
• Interventions: Device: Vibration; Other: Tapping

• Registration Number: NCT06355817
• Lead Sponsor: University of Manitoba

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.

Study Timeline

• Study Start: 2023-09-21
• Primary Completion: 2024-03-19
• Study Completion: 2024-03-19
• Study First Submitted: 2024-03-28
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-03
• Study First Posted: 2024-04-09
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• adult patients undergoing elective bilateral eye procedures such as blepharoplasty

Exclusion Criteria

• previous eyelid surgery
• inability to give consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B: Vibrate then Tap	Vibration	Vibration first, then tapping
Group B: Vibrate then Tap	Tapping	Vibration first, then tapping
Group A: Tap then Vibrate	Vibration	Tapping for the first eye/side during infiltration of local anesthetic, then vibration for the second eye.
Group A: Tap then Vibrate	Tapping	Tapping for the first eye/side during infiltration of local anesthetic, then vibration for the second eye.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Misericordia Health Centre; 🇨🇦 Winnipeg, Manitoba, Canada