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Clinical Trials/NCT02892513
NCT02892513CompletedNot Applicable

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

Medical College of Wisconsin1 site in 1 country53 target enrollmentStarted: November 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
53
Locations
1
Primary Endpoint
Total Narcotic Consumption During Hospital Stay

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Active Stimulation

Experimental

Participants will have active percutaneous auricular neurostimulation for 5 days during and after elective surgery.

Intervention: Percutaneous auricular neurostimulation (Device)

Sham Percutaneous Neurostimulation

Sham Comparator

Participants will have inactive device worn for 5 days during and after elective surgery.

Intervention: Sham percutaneous auricular neurostimulation (Device)

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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Carrie Peterson

Assistant Professor

Medical College of Wisconsin

Study Sites (1)

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