Auricular Percutaneous Electrical Nerve Field Stimulation for Postoperative Pain Control in Adults

Study Overview
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Brief Summary
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Pain after surgery is unavoidable, and opioid medications are the cornerstone of most pain management regimens. However, they come at a cost with profound impacts on gastrointestinal motility, respiratory depression, and even long-term dependence. Stimulating the external ear with cutaneous electrical current is similar to acupuncture and could help improve postoperative pain. The Bridge device (manufactured by Key Electronics [Jeffersonville, IN, USA] and distributed by Innovative Health Solutions [Versailles, IN, USA]), has been used with success in treating opioid withdrawal and in animal studies has shown increases in pain thresholds. The investigators propose a prospective, randomized, placebo-controlled, double-blinded trial to evaluate if auricular neurostimulation improves postoperative pain and reduces opioid requirements for patients undergoing elective colon surgery. pain perception in post-operative patients may be modulated via the auricular branch of the vagus nerve. This has the potential to reduce the use of opioid medications, which will in turn reduce the incidence of postoperative ileus and reduce patient need for and dependence on narcotic pain medications. This would have an enormous economic impact due to decreased length of hospital stays for patients who undergo abdominal surgery. In addition, opioid reduction could potentially lessen the national crisis of opioid addiction.

Official Title
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Auricular Percutaneous Electrical Nerve Field Stimulation for Postoperative Pain Control in Adults

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Device: Percutaneous auricular neurostimulation
* Device: Sham percutaneous auricular neurostimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective colon surgery age over 18 years provide informed consent Exclusion Criteria: emergency surgery history of opioid dependence/use, anxiety with anxiolytic use planned ICU admission postoperatively adhesive allergy/sensitivity other medical contraindications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Stimulation<br>Participants will have active percutaneous auricular neurostimulation for 5 days during and after elective surgery. | Device: Percutaneous auricular neurostimulation<br>* The Bridge device (manufactured by Key Electronics [Jeffersonville, IN, USA] and distributed by Innovative Health Solutions [Versailles, IN, USA]) provides continual neurostimulation for five days with alternating current.<br>|
| Sham Comparator: Sham Percutaneous Neurostimulation<br>Participants will have inactive device worn for 5 days during and after elective surgery. | Device: Sham percutaneous auricular neurostimulation<br>* Identical in appearance to active, device, but no stimulation will be given.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Narcotic Consumption During Hospital Stay | Total inpatient narcotic use measured in oral morphine equivalents per day (OME) | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Surgery, transcutaneous electric nerve stimulation