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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
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Colorectal Surgery, transcutaneous electric nerve stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 2, 2016
Last Updated
April 12, 2019
Sponsor
Medical College of Wisconsin
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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

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

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