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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intraoperative (within the operating room)

Awards & highlights

Study Summary

This trial is exploring a new device called "Bridge" which may reduce post-surgery pain with fewer side effects than opioids. It stimulates nerves in the ear and may reduce pain without risk of dependence, abuse or diversion.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,120 Previous Clinical Trials

1,521,257 Total Patients Enrolled

6 Trials studying Postoperative Pain

401 Patients Enrolled for Postoperative Pain

Brian M Ilfeld, MD, MsPrincipal InvestigatorUniversity of California, San Diego

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open for the current iteration of this research study?

"According to clinicaltrials.gov, this particular trial is no longer recruiting new candidates as it was initially published on the 12th of October 2022 and last updated two days later. Despite this study not being available for enrollment at the moment, there are 590 other studies which require participants."

Answered by AI

What are the intended outcomes of this investigation?

"This clinical trial will measure Total OPIOID consumption, Awakenings due to pain, Surgical duration and LEAST (lowest or minimum) pain using the Numeric Rating Scale over five postoperative days. The Numeric Rating Scale ranges from 0-10 with 0 denoting no pain and 10 being 'worst imaginable' ache intensity."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Percutaneous Auricular Neuromodulation for Postoperative Analgesia

Brian M. Ilfeld, MD, MS 2022. "Percutaneous Auricular Neuromodulation for Postoperative Analgesia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05521516.

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