What side effects are associated with this type of intervention?

Common treatments for postoperative pain include opioids, peripheral nerve blocks, and electrical neuromodulation techniques such as auricular neuromodulation. Opioids are effective but come with side effects like nausea, vomiting, sedation, respiratory depression, and a risk of abuse and dependence. Peripheral nerve blocks provide potent site-specific analgesia but are limited by their short duration of action and potential for nerve damage. Auricular neuromodulation, which involves electrical stimulation of cranial and peripheral nerves to influence the limbic system, has fewer side effects, with minimal contraindications and no significant risks of dependence or systemic side effects.

What prior FDA approvals exist?

The FDA has approved the 'Bridge' system for auricular neuromodulation, which involves electrical stimulation of cranial and peripheral nerves to influence the limbic system. This device is primarily approved to reduce symptoms associated with opioid withdrawal but has shown potential for postoperative analgesia. It offers a non-opioid alternative for pain management with fewer side effects and no risk of dependence or abuse. Other related treatments include peripheral nerve blocks and spinal cord stimulation, which also aim to modulate nerve activity to manage pain.

What other types of research exist?

Promising alternatives to auricular neuromodulation for postoperative pain management include: 1) Spinal Cord Stimulation (SCS), which has shown effectiveness in various pain conditions including postoperative pain. 2) Transcutaneous Electrical Nerve Stimulation (TENS), which is non-invasive and has been effective in reducing pain in several studies. 3) High-frequency (10-kHz) Spinal Cord Stimulation, which has demonstrated significant pain relief in clinical trials. 4) Acupuncture, which has been supported by several studies for its efficacy in pain management. These alternatives offer different mechanisms of action and can be considered based on individual patient needs and responses.

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Neuromodulation Device

Percutaneous Auricular Neuromodulation for Postoperative Pain

N/A

Waitlist Available

Led By Brian M Ilfeld, MD, Ms

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older

Undergoing one of the specified surgical procedures as a primary procedure (not revision)

Must not have

Morbid obesity as defined by a body mass index > 40

Skin abnormality at the treatment site

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intraoperative (within the operating room)

Summary

This trial is testing a small device placed on the ear that sends electrical signals to help reduce pain after surgery. It targets adults who usually experience moderate-to-severe pain post-surgery. The device works by blocking pain messages from reaching the brain, which may reduce the need for opioid painkillers.

Who is the study for?

This trial is for adults over 18 who are having certain surgeries and can communicate with the staff. It's not for those with electric stimulators like pacemakers, blood thinners, skin issues at the ear, opioid abuse history, pregnancy, multiple surgeries at once, in jail, muscle problems in the surgery area, chronic opioid use recently or a BMI over 40.

What is being tested?

The study tests if auricular neuromodulation using a device called NSS-2 Bridge can reduce post-surgery pain better than a sham treatment. The device stimulates nerves in the ear to potentially ease pain without opioids' side effects.

What are the potential side effects?

The NSS-2 Bridge has few reported side effects and is considered safe with no potential for dependence or abuse. Side effects may include local irritation where it attaches to the ear.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am having a specific surgery for the first time.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My BMI is over 40, indicating morbid obesity.

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I have a skin issue where I will receive treatment.

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I have muscle or nerve problems in the area where I had surgery.

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I cannot communicate with doctors or hospital staff.

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I am undergoing or have undergone surgery on both sides of my body or multiple surgeries.

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I have been using opioids or tramadol daily for more than 4 weeks.

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I have a bleeding disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ recorded on postoperative days 2, 4, 6, and 8 for the previous 24-hour period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~recorded on postoperative days 2, 4, 6, and 8 for the previous 24-hour period

This trial's timeline: 3 weeks for screening, Varies for treatment, and recorded on postoperative days 2, 4, 6, and 8 for the previous 24-hour period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AVERAGE pain measured with the Numeric Rating Scale first 5 postoperative days

Total OPIOID consumption from recovery room discharge until the data collection phone call on postoperative day 5 (measured in oral oxycodone equivalents)

Secondary study objectives

AVERAGE pain measured with the Numeric Rating Scale

Pain

Brief pain Inventory, short form (interference subscale)

+10 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active Percutaneous Auricular Neuromodulation with NSS-2 BridgeActive Control1 Intervention

Application of 5 days of percutaneous auricular Neuromodulation with NSS-2 Bridge device

Group II: Sham TreatmentPlacebo Group1 Intervention

Application of 5 days of a nonfunctional sham device

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Auricular neuromodulation, a form of electrical stimulation targeting cranial and peripheral nerves, influences the limbic system to provide analgesia. This method works by placing small electrodes in the ear to stimulate nerves that modulate pain perception and stress responses in the brain. It offers potent, site-specific pain relief with minimal side effects and no risk of dependence, making it a valuable alternative to opioids and peripheral nerve blocks, which have limitations such as short duration of action and potential for abuse. This is particularly important for postoperative pain patients who require effective, long-lasting pain management without the drawbacks of traditional opioid therapy.

Observations on fast axoplasmic transport in peripheral nerve following repetitive electrical stimulation.Low current electrostimulation produces naloxone-reversible analgesia in rats.[Clinical and experimental analysis of the use of the Analgedent electrostimulator for dental analgesia].