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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02892513
Recruitment Status : Completed
First Posted : September 8, 2016
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Carrie Peterson, Medical College of Wisconsin

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Device: Percutaneous auricular neurostimulation Device: Sham percutaneous auricular neurostimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Auricular Percutaneous Electrical Nerve Field Stimulation for Postoperative Pain Control in Adults
Study Start Date : November 2016
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Active Stimulation
Participants will have active percutaneous auricular neurostimulation for 5 days during and after elective surgery.
 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.
Sham Comparator: Sham Percutaneous Neurostimulation
Participants will have inactive device worn for 5 days during and after elective surgery.
 Device: Sham percutaneous auricular neurostimulation
Identical in appearance to active, device, but no stimulation will be given.


Outcome Measures
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Primary Outcome Measures :
  1. Total Narcotic Consumption During Hospital Stay [ Time Frame: 5 days ]
    Total inpatient narcotic use measured in oral morphine equivalents per day (OME)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892513


Locations
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United States, Wisconsin
Medical College of Wisconsin - Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
  Study Documents (Full-Text)

Documents provided by Carrie Peterson, Medical College of Wisconsin:
Study Protocol  [PDF] October 4, 2016
Statistical Analysis Plan  [PDF] October 4, 2016
Informed Consent Form  [PDF] March 2, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Carrie Peterson, Assistant Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02892513    
Other Study ID Numbers: PRO00027872
First Posted: September 8, 2016    Key Record Dates
Results First Posted: May 7, 2019
Last Update Posted: May 7, 2019
Last Verified: April 2019
Keywords provided by Carrie Peterson, Medical College of Wisconsin:
Colorectal Surgery
transcutaneous electric nerve stimulation
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations