N/A
N=122
Percutaneous Auricular Neuromodulation for Postoperative Analgesia
Postoperative Pain, Acute
Bottom Line
View on ClinicalTrials.gov: NCT05521516 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: AVERAGE Pain Measured With the Numeric Rating Scale First 5 Postoperative Days — 1; 3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge (Device); Sham Treatment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AVERAGE Pain Measured With the Numeric Rating Scale First 5 Postoperative Days |
1; 3 | — |
| PRIMARY Total OPIOID Consumption From Recovery Room Discharge Until the Data Collection Phone Call on Postoperative Day 5 (Measured in Oral Oxycodone Equivalents) |
5; 17.5 | — |
| SECONDARY AVERAGE Pain Measured With the Numeric Rating Scale |
2.3; 2.8; 1.9; 3.3; 1.8; 3 | — |
| SECONDARY WORST (Highest or Maximum) Pain Measured With the Numeric Rating Scale |
4.3; 4.9; 4; 5.5; 3.7; 4.9 | — |
| SECONDARY LEAST (Lowest or Minimum) Pain Measured With the Numeric Rating Scale |
1; 1.8; .7; 1.2; .6; 1.2 | — |
| SECONDARY CURRENT Pain at the Time of the Data-collection Phone Call Measured With the Numeric Rating Scale |
1.5; 3; 1.3; 2; 1.3; 1.9 | — |
| SECONDARY Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) |
4.5; 8; 6; 8; 5; 8 | — |
| SECONDARY Brief Pain Inventory, Short Form (Interference Subscale) |
14; 23; 11; 18; 12; 17 | — |
| SECONDARY Awakenings Due to Pain |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Masking |
.5; .5 | — |
| SECONDARY Hospitalization Duration Measured in Days |
.2; .5 | — |
| SECONDARY Tourniquet Duration |
.8; 1.8 | — |
| SECONDARY Surgical Duration |
92.4; 89.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05521516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.