Distraction Techniques in Periocular Anesthesia: Tapping vs Vibration

NCT06355817 | Completed

• 1 other identifier: HS25941
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy of topical tapping vs vibration in lowering pain scores for periocular anesthesia injections.

Conditions

Anesthetics, Local; Blepharoplasty; Age-Related Ptosis; Adult; Humans; Lidocaine; Ophthalmologic Surgical Procedure; Vibration; Surgery

Keywords

Study, Crossover; Pain Measurement; Prospective Study

Outcome Measures

Primary Outcomes (1)

• Pain Reduction in Tapping vs Vibration distraction techniques in peri-ocular local anesthesia

  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)

  Immediately after both eyes receive local anesthetic

Secondary Outcomes (1)

• Difference in Pain Reduction

  Immediately after both eye receive local anesthetic

Study Arms (2)

Group A: Tap then Vibrate

ACTIVE COMPARATOR

Tapping for the first eye/side during infiltration of local anesthetic, then vibration for the second eye.

Device: Vibration; Other: Tapping

Group B: Vibrate then Tap

EXPERIMENTAL

Vibration first, then tapping

Device: Vibration; Other: Tapping

Interventions

Vibration DEVICE

Vibration Assist Device, held to the forehead

Also known as: Facial Massager

Group A: Tap then Vibrate; Group B: Vibrate then Tap

Tapping OTHER

Tapping on the forehead

Group A: Tap then Vibrate; Group B: Vibrate then Tap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients undergoing elective bilateral eye procedures such as blepharoplasty

You may not qualify if:

• previous eyelid surgery
• inability to give consent

Sponsors & Collaborators

• University of Manitoba: lead
• Winnipeg Regional Health Authority: collaborator

Study Sites (1)

Misericordia Health Centre

Winnipeg, Manitoba, R3C 1A2, Canada

Location

Related Publications (15)

• Gostimir M, Hussain A. A Systematic Review and Meta-analysis of Methods for Reducing Local Anesthetic Injection Pain Among Patients Undergoing Periocular Surgery. Ophthalmic Plast Reconstr Surg. 2019 Mar/Apr;35(2):113-125. doi: 10.1097/IOP.0000000000001209.

  PMID: 30664129 BACKGROUND

• Aminabadi NA, Farahani RM, Balayi Gajan E. The efficacy of distraction and counterstimulation in the reduction of pain reaction to intraoral injection by pediatric patients. J Contemp Dent Pract. 2008 Sep 1;9(6):33-40.

  PMID: 18784857 BACKGROUND

• Strazar AR, Leynes PG, Lalonde DH. Minimizing the pain of local anesthesia injection. Plast Reconstr Surg. 2013 Sep;132(3):675-684. doi: 10.1097/PRS.0b013e31829ad1e2.

  PMID: 23985640 BACKGROUND

• Babamiri K, Nassab R. The evidence for reducing the pain of administration of local anesthesia and cosmetic injectables. J Cosmet Dermatol. 2010 Sep;9(3):242-5. doi: 10.1111/j.1473-2165.2010.00503.x.

  PMID: 20883298 BACKGROUND

• Govas P, Kazi R, Slaugenhaupt RM, Carroll BT. Effect of a Vibratory Anesthetic Device on Pain Anticipation and Subsequent Pain Perception Among Patients Undergoing Cutaneous Cancer Removal Surgery: A Randomized Clinical Trial. JAMA Facial Plast Surg. 2019 Dec 1;21(6):480-486. doi: 10.1001/jamafacial.2019.0733.

  PMID: 31513234 BACKGROUND

• Ing EB, Philteos J, Sholohov G, Kim DT, Nijhawan N, Mark PW, Gilbert J. Local anesthesia and anxiolytic techniques for oculoplastic surgery. Clin Ophthalmol. 2019 Jan 10;13:153-160. doi: 10.2147/OPTH.S188790. eCollection 2019.

  PMID: 30666086 BACKGROUND

• Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.

  PMID: 5320816 BACKGROUND

• Chen BK, Eichenfield LF. Pediatric anesthesia in dermatologic surgery: when hand-holding is not enough. Dermatol Surg. 2001 Dec;27(12):1010-8. doi: 10.1046/j.1524-4725.2001.01854.x.

  PMID: 11849262 BACKGROUND

• Smith KC, Comite SL, Balasubramanian S, Carver A, Liu JF. Vibration anesthesia: a noninvasive method of reducing discomfort prior to dermatologic procedures. Dermatol Online J. 2004 Oct 15;10(2):1.

  PMID: 15530291 BACKGROUND

• McKinlay JR, Hofmeister E, Ross EV, MacAllister W. EMLA cream-induced eye injury. Arch Dermatol. 1999 Jul;135(7):855-6. doi: 10.1001/archderm.135.7.855. No abstract available.

  PMID: 10411170 BACKGROUND

• Reed ML. Surgical pearl: mechanoanesthesia to reduce the pain of local injections. J Am Acad Dermatol. 2001 Apr;44(4):671-2. doi: 10.1067/mjd.2001.110641. No abstract available.

  PMID: 11260545 BACKGROUND

• Katz J, Melzack R. Measurement of pain. Surg Clin North Am. 1999 Apr;79(2):231-52. doi: 10.1016/s0039-6109(05)70381-9.

  PMID: 10352653 BACKGROUND

• Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.

  PMID: 11690728 BACKGROUND

• Fayers T, Morris DS, Dolman PJ. Vibration-assisted anesthesia in eyelid surgery. Ophthalmology. 2010 Jul;117(7):1453-7. doi: 10.1016/j.ophtha.2009.11.025. Epub 2010 Mar 19.

  PMID: 20303597 RESULT

• Sharma P, Czyz CN, Wulc AE. Investigating the efficacy of vibration anesthesia to reduce pain from cosmetic botulinum toxin injections. Aesthet Surg J. 2011 Nov;31(8):966-71. doi: 10.1177/1090820X11422809. Epub 2011 Oct 14.

  PMID: 22001341 RESULT

Related Links

• Specific vibration assist device used in the study

Study Officials

• Yen Minh Cung, MD

  University of Manitoba, Dept of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principle Investigator

Model Details: Each patient will receive both interventions and serve as their own comparator.

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 9, 2024
• Study Start: September 21, 2023
• Primary Completion: March 19, 2024
• Study Completion: March 19, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)