Vibration Anesthesia for Perioperative Pain

Overseen By Mathieu Carrière, MD, FRCSC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Poor pupil dilation, Media opacity

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Vibration Anesthesia Device treatment for perioperative pain?

Research shows that using a vibrating device can significantly reduce pain during local anesthesia injections in both children and adults. Studies found that vibrations help lower discomfort and pain perception, making the procedure more comfortable. ^{1 2 3 4 5}

How does vibration anesthesia differ from other treatments for perioperative pain?

Vibration anesthesia is unique because it uses a vibrating device to reduce pain, making it different from traditional methods that rely solely on drugs or injections. This technique is noninvasive and can make procedures more tolerable by providing a counter-stimulatory effect that distracts from the pain. ^{1 3 6 7 8}

What is the purpose of this trial?

The goal of this clinical trial is to learn if Vibration Anesthesia Device works to reduce pain during retinal laser for diabetic retinopathy. The main question it aims to answer is: Does the Vibration Anesthesia Device reduces the pain felt by patients during the laser treatment? Researchers will compare the standard method (no vibration device) to the standard method with the Vibration Anesthesia Device to see if the device works to reduce discomfort during treatment. Eligible participants will have both eyes treated as required, one eye with the device and the other one without. Both the side that will be treated with the device in place and the first side to be treated will be decided by random sequence.

Research Team

Matthew Tennant, MD, FRCSC

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for individuals with diabetic retinopathy who need retinal laser treatment. Participants will have both eyes treated, one with a Vibration Anesthesia Device to potentially reduce pain and the other without it.

Inclusion Criteria

* Bilateral PRP for proliferative diabetic retinopathy required

* \>500 applications to each eye

* \< 51 applications difference between each eye, in the superior or inferior hemisphere.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive panretinal photocoagulation (PRP) treatment with and without the Vibration Anesthesia Device to assess pain reduction

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Vibration Anesthesia Device

Trial Overview The study is testing if using a Vibration Anesthesia Device during retinal laser therapy can lessen the pain compared to the standard method without vibration. Each patient's eyes serve as their own control in this random sequence comparison.

Participant Groups

Group I: PRP with the Vibration Anesthesia Device Experimental Treatment 2 Interventions

Laser for PRP treatment as usual, but with the addition of the Vibration Device in one of the two eyes of a patient (The other eye receiving the same laser treatment without the device).

Group II: PRP without the Vibration Anesthesia Device Active Control 1 Intervention

Laser for PRP treatment as usual in one of the two eyes of a patient (other eye receiving the same treatment, but with the Vibration Device).

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Alberta Retina Consultant

Collaborator

Trials

2

Recruited

130+

Findings from Research

The use of vibration anesthesia with the DentalVibe device significantly reduced pain during digital block injections in the hand, with a mean pain score of 2.52 compared to 4.28 in the sham group, indicating its efficacy in pain management.

This randomized controlled trial involved 25 adult patients over a 24-month period, and the results suggest that microvibratory stimulation can effectively alleviate pain during local anesthetic procedures, warranting further research with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Dental Vibration Tool to Reduce Pain From Digital Blocks: A Randomized Controlled Trial. Pedersen, C., Miller, M., Xu, KT., et al.[2019]

Vibration anesthesia, using inexpensive massagers, effectively reduces discomfort during various dermatologic and cosmetic procedures, including botulinum toxin injections and laser therapies.

While vibration anesthesia may not completely eliminate pain, it significantly enhances the tolerability of injections, making it a valuable option for patients who are averse to needles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibration anesthesia: a noninvasive method of reducing discomfort prior to dermatologic procedures. Smith, KC., Comite, SL., Balasubramanian, S., et al.[2022]

References

1. India pubmed.ncbi.nlm.nih.gov

Efficacy of an Innovative Device in Reducing Discomfort during Local Anesthesia Administration in Children: A Clinical Study. [2022]

2. Denmark pubmed.ncbi.nlm.nih.gov

The effectiveness of electronic pulsed soft tissue vibration compared with topical anaesthesia in reducing the pain of injection of local anaesthetics in adults: a randomized controlled split-mouth clinical trial. [2021]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

The effect of vibratory stimulus on pain perception during intraoral local anesthesia administration in children: a systematic review and meta-analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Vibratory stimulation for the relief of pain of dental origin. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of a vibratory device on pain from anesthetic injections. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Vibration anesthesia for the reduction of pain with facial dermal filler injections. [2014]

7. England pubmed.ncbi.nlm.nih.gov

Use of a Dental Vibration Tool to Reduce Pain From Digital Blocks: A Randomized Controlled Trial. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Vibration anesthesia: a noninvasive method of reducing discomfort prior to dermatologic procedures. [2022]