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OpenTrials
Completed

NCT Number: NCT02892513

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin - Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous auricular neurostimulation

Device

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.

Sham percutaneous auricular neurostimulation

Device

Identical in appearance to active, device, but no stimulation will be given.

Primary outcomes

  1. Total Narcotic Consumption During Hospital Stay

    Time frame: 5 days

    Total inpatient narcotic use measured in oral morphine equivalents per day (OME)

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 8, 2016
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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