Auricular Percutaneous Electrical Nerve Field Stimulation for Postoperative Pain Control in Adults
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous auricular neurostimulation
Sham percutaneous auricular neurostimulation
Sponsored by

About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Colorectal Surgery, transcutaneous electric nerve stimulation
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
Sites / Locations
- Medical College of Wisconsin - Froedtert Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active Stimulation
Sham Percutaneous Neurostimulation
Arm Description
Participants will have active percutaneous auricular neurostimulation for 5 days during and after elective surgery.
Participants will have inactive device worn for 5 days during and after elective surgery.
Outcomes
Primary Outcome Measures
Total Narcotic Consumption During Hospital Stay
Total inpatient narcotic use measured in oral morphine equivalents per day (OME)
Secondary Outcome Measures
Full Information
NCT ID
NCT02892513
First Posted
September 2, 2016
Last Updated
April 12, 2019
Sponsor
Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT02892513
Brief Title
Auricular Percutaneous Electrical Nerve Field Stimulation for Postoperative Pain Control in Adults
Official Title
Auricular Percutaneous Electrical Nerve Field Stimulation for Postoperative Pain Control in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Colorectal Surgery, transcutaneous electric nerve stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Stimulation
Arm Type
Experimental
Arm Description
Participants will have active percutaneous auricular neurostimulation for 5 days during and after elective surgery.
Arm Title
Sham Percutaneous Neurostimulation
Arm Type
Sham Comparator
Arm Description
Participants will have inactive device worn for 5 days during and after elective surgery.
Intervention Type
Device
Intervention Name(s)
Percutaneous auricular neurostimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham percutaneous auricular neurostimulation
Intervention Description
Identical in appearance to active, device, but no stimulation will be given.
Primary Outcome Measure Information:
Title
Total Narcotic Consumption During Hospital Stay
Description
Total inpatient narcotic use measured in oral morphine equivalents per day (OME)
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Medical College of Wisconsin - Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33417346
Citation
Blank JJ, Liu Y, Yin Z, Spofford CM, Ridolfi TJ, Ludwig KA, Otterson MF, Peterson CY. Impact of Auricular Neurostimulation in Patients Undergoing Colorectal Surgery with an Enhanced Recovery Protocol: A Pilot Randomized, Controlled Trial. Dis Colon Rectum. 2021 Feb 1;64(2):225-233. doi: 10.1097/DCR.0000000000001752.
Results Reference
derived
Learn more about this trial
Auricular Percutaneous Electrical Nerve Field Stimulation for Postoperative Pain Control in Adults
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