Vibration Anesthesia for Perioperative Pain

MC
Overseen ByMathieu Carrière, MD, FRCSC
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alberta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a Vibration Anesthesia Device can reduce pain during laser treatments for diabetic retinopathy, a vision-affecting condition caused by diabetes. Participants will receive treatment in both eyes: one with the vibration device and the other without, to determine if the device increases comfort. This study suits individuals who have not previously undergone this type of laser treatment and require it for both eyes due to this condition. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance comfort during necessary treatments.

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 prior data suggests that the Vibration Anesthesia Device is safe for reducing pain during retinal laser treatment?

Studies have shown that a vibration anesthesia device can help reduce pain. In one study, patients reported a 25.5% decrease in pain during local anesthetic injections when the device was used. Another report found that 95% of patients felt less pain with vibration, although none were completely pain-free.

Research also shows that these vibration devices can lessen pain during procedures like dental work and injections in the arms. These findings suggest that the device is generally well-received and can make procedures less painful for many people. No major safety issues emerged in these studies.12345

Why are researchers excited about this trial?

Researchers are excited about the Vibration Anesthesia Device because it introduces a non-invasive way to manage pain during laser treatments for proliferative retinopathy (PRP). Traditional treatments typically focus on medications or nerve blocks to alleviate pain, but this device uses vibrations to distract the brain from pain signals, potentially reducing the need for drugs. This innovative approach could lead to a more comfortable experience for patients undergoing laser eye procedures and minimize reliance on conventional pain relief methods.

What evidence suggests that the Vibration Anesthesia Device is effective for reducing pain during retinal laser treatment for diabetic retinopathy?

Studies have shown that vibration devices can significantly reduce pain during medical procedures. For example, using a vibration device during local anesthetic injections reduced pain by 25.5%. Research also indicates that these devices improve patient satisfaction during arm injections by reducing pain afterward. Vibration devices have proven more effective than numbing creams for reducing pain from dental injections. In this trial, one group will receive PRP treatment with the Vibration Anesthesia Device, while the other group will receive PRP treatment without it. These findings suggest that vibration anesthesia could help lessen pain during eye laser treatments for diabetic retinopathy.13456

Who Is on the Research Team?

MT

Matthew Tennant, MD, FRCSC

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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.
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Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: PRP with the Vibration Anesthesia DeviceExperimental Treatment2 Interventions
Group II: PRP without the Vibration Anesthesia DeviceActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+

Alberta Retina Consultant

Collaborator

Trials
2
Recruited
130+

Published Research Related to This Trial

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

Citations

Effect of a Vibratory Anesthetic Device on Pain Anticipation ...The addition of vibration resulted in a 25.5% reduction of Numeric Rating Scale scores during local anesthetic injection in patients who ...
Effectiveness of using a vibration device to ease pain...Our study proves that using a vibration device during upper extremity injections can effectively reduce postinjection pain and improve patient satisfaction.
Vibration Anesthesia for Perioperative PainResearch shows that using a vibrating device can significantly reduce pain during local anesthesia injections in both children and adults. Studies found that ...
The Effectiveness of Soft Tissue Vibration in Reducing Pain ...The clinical trial will compare pain perception during dental local anesthesia injections with and without using soft tissue vibration device prior to injection ...
The effectiveness of electronic pulsed soft tissue vibration ...The vibration device was clinically and statistically more effective than topical anaesthesia in the reduction of dental injection pain in adults, measured ...
Vibration Anesthesia During Invasive Procedures: A Meta- ...About 95 percent of patients reported a significant reduction in their symptoms of pain, with notably zero patients recording an absence of pain when treated ...
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