Percutaneous Auricular Neuromodulation for Postoperative Analgesia

NCT05521516 | Completed Results FDA Device

• 1 other identifier: Auricular NeuromodulationPilot
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

The moderate-to-severe pain many patients experience following surgery is often treated with opioids, which are associated with side effects such as nausea/vomiting, sedation, and respiratory depression (and a risk of abuse, dependence, and diversion). Potent site-specific analgesia with fewer side effects may be provided with peripheral nerve blocks. However, these too have limitations such as a duration of action measured in hours, while the pain from surgery is usually measured in days or weeks. Peripheral nerve stimulation or "neuromodulation" is an alternative method of pain control involving the introduction of electrical current to stimulate various nerves that do not carry pain sensations, but which then decreases communication between pain fibers and the spinal cord and/or brain. Placing small electrodes specifically in the area of the ear is called "auricular neuromodulation" and is theorized to function by stimulating various cranial and peripheral nerves that influence a part of the brain called the "limbic system" which is involved with many aspects of behavior including responses to stress. A device that delivers auricular neuromodulation, the "Bridge" system, is approved by the United States Food and Drug Administration for use to reduce symptoms associated with opioid withdrawal for up to 5 days. However, one prospective and two published retrospective studies suggest that it may provide postoperative analgesia as well. The device itself is relatively simple to apply; has few contraindications, side effects, or adverse events; and has no potential for dependence, abuse, or diversion. Therefore, it has the potential to concurrently improve analgesia and decrease or even negate opioid requirements following surgery, only without the limitations of opioids and peripheral nerve blocks. The purpose of this pilot study is to explore the possibility of treating postoperative pain with percutaneous auricular neuromodulation, optimize the study protocol, and estimate the treatment effect in preparation for developing a subsequent definitive clinical trial.

Conditions

Postoperative Pain, Acute

Outcome Measures

Primary Outcomes (2)

• AVERAGE Pain Measured With the Numeric Rating Scale First 5 Postoperative Days

  The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will the mean value of daily average pain scores measured with the Numeric Rating Scale. The primary outcome measure will be the mean value of the average daily pain measured on postoperative days 1-5.

  The 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)

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

  Postoperative days 0-5

Secondary Outcomes (11)

• AVERAGE Pain Measured With the Numeric Rating Scale

  Recorded on postoperative days 1-8 for the previous 24-hour period

• WORST (Highest or Maximum) Pain Measured With the Numeric Rating Scale

  Recorded on postoperative days 1-8 for the previous 24-hour period

• LEAST (Lowest or Minimum) Pain Measured With the Numeric Rating Scale

  Recorded on postoperative days 2, 4, 6, and 8 for the previous 24-hour period

• CURRENT Pain at the Time of the Data-collection Phone Call Measured With the Numeric Rating Scale

  Recorded on postoperative days 2, 4, 6, and 8

• Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)

  Recorded on postoperative days 1-8

Study Arms (2)

Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge

ACTIVE COMPARATOR

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

Device: Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge

Sham Treatment

SHAM COMPARATOR

Application of 5 days of a nonfunctional sham device

Device: Sham Treatment

Interventions

Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge DEVICE

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

Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge

Sham Treatment DEVICE

Application of 5 days of a nonfunctional sham device

Also known as: Placebo

Sham Treatment

Eligibility Criteria

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

You may qualify if:

• undergoing one of these surgical procedures as a primary procedure (not revision):
• septoplasty \[infraorbital nerve block\]
• laparoscopic cholecystectomy \[transversus abdominis nerve block\]
• laparoscopic sleeve gastrectomy \[transversus abdominis nerve block\]
• non-mastectomy breast surgery \[paravertebral nerve block\]
• percutaneous nephrolithotomy \[erector spinae plane nerve block\]
• inguinal hernia repair \[transversus abdominis nerve block\]
• knee arthroplasty \[adductor canal nerve block\]
• hip arthroplasty \[pericapsular nerve group block\]
• shoulder acromioclavicular joint repair, labral repair, subacromial decompression, or Bankart repair (without rotator cuff repair) \[interscalene nerve block\]
• orthopedic hardware removal anticipated to be at least moderately painful postoperatively \[various peripheral nerve blocks\]
• analgesic plan includes a single-injection peripheral nerve block with a long-acting local anesthetic \[may be waived for hip arthroplasty\]
• age 18 years or older.

You may not qualify if:

• concurrent use of another electric stimulator (e.g., cardiac pacemaker)
• bleeding disorder
• anticoagulation
• skin abnormality at the treatment site
• psoriasis vulgaris
• morbid obesity as defined by a body mass index \> 40
• history of opioid abuse
• inability to communicate with the investigators or hospital staff
• pregnancy
• bilateral or multi-stage surgical procedures
• incarceration
• chronic opioid or tramadol use (daily use within the 2 weeks prior to surgery and duration of use \> 4 weeks)
• neuro-muscular deficit of the surgical area/limb.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92130, United States

Location

Related Publications (3)

• Ilfeld BM, Abramson WB, Said ET, Sztain JF, Finneran JJ 4th, Griggs JL, Abdullah B, Jensen EJ, Schaar A, Wallace AM. Percutaneous auricular neuromodulation to treat pain after ambulatory breast surgery: A randomized, double-masked, sham-controlled pilot study. Can J Pain. 2025 Jul 10;9(1):2521117. doi: 10.1080/24740527.2025.2521117. eCollection 2025.

  PMID: 40657450 DERIVED

• Ilfeld BM, Finneran JJ 4th, Alexander B, Abramson WB, Sztain JF, Ball ST, Gonzales FB, Abdullah B, Cha BJ, Said ET. Percutaneous auricular neuromodulation (nerve stimulation) for the treatment of pain following total knee arthroplasty: a randomized, double-masked, sham-controlled pilot study. Reg Anesth Pain Med. 2025 Jan 7;50(1):26-35. doi: 10.1136/rapm-2023-105028.

  PMID: 38388019 DERIVED

• Ilfeld BM, Abramson WB, Alexander B, Sztain JF, Said ET, Broderick RC, Sandler BJ, Doucet JJ, Adams LM, Abdullah B, Cha BJ, Finneran JJ 4th. Percutaneous auricular neuromodulation (nerve stimulation) for the treatment of pain following cholecystectomy and hernia repair: a randomized, double-masked, sham-controlled pilot study. Reg Anesth Pain Med. 2024 Sep 2;49(9):628-634. doi: 10.1136/rapm-2024-105283.

  PMID: 38388014 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Brian Ilfeld, MD, MS
• Organization: University of California San Diego

bilfeld@health.ucsd.edu

(858) 220-5714

Study Officials

• Brian M Ilfeld, MD, Ms

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Investigational Drug Service will create the randomization tables and provide the investigators with the appropriate device (active or sham), leaving all participants, investigators, and the statistician masked to treatment group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, In Residence

Model Details: Parallel Assignment: Randomized, Triple-Masked, Placebo-Controlled, Parallel-Arm Human Subjects Clinical Trial

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 30, 2022
• Study Start: October 12, 2022
• Primary Completion: December 8, 2024
• Study Completion: December 11, 2024
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)