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

NCT02892513 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2019-05-07

Study results available
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Summary

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.

Conditions

  • Pain, Postoperative

Interventions

DEVICE

Percutaneous auricular neurostimulation

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.

DEVICE

Sham percutaneous auricular neurostimulation

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

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02892513 on ClinicalTrials.gov