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Clinical Trials/NCT02892513
NCT02892513
Completed
Not Applicable

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

Medical College of Wisconsin1 site in 1 country53 target enrollmentNovember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
Medical College of Wisconsin
Enrollment
53
Locations
1
Primary Endpoint
Total Narcotic Consumption During Hospital Stay
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
April 30, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carrie Peterson

Assistant Professor

Medical College of Wisconsin

Eligibility Criteria

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

Outcomes

Primary Outcomes

Total Narcotic Consumption During Hospital Stay

Time Frame: 5 days

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

Study Sites (1)

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