NCT02892513

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
1 year until next milestone

Results Posted

Study results publicly available

May 7, 2019

Completed
Last Updated

May 7, 2019

Status Verified

April 1, 2019

Enrollment Period

1.5 years

First QC Date

September 2, 2016

Results QC Date

April 12, 2019

Last Update Submit

April 12, 2019

Conditions

Pain, Postoperative

Keywords

Colorectal Surgerytranscutaneous electric nerve stimulation

Outcome Measures

Primary Outcomes (1)

  • Total Narcotic Consumption During Hospital Stay

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

    5 days

Study Arms (2)

Active Stimulation

EXPERIMENTAL

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

Device: Percutaneous auricular neurostimulation

Sham Percutaneous Neurostimulation

SHAM COMPARATOR

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

Device: Sham percutaneous auricular neurostimulation

Interventions

Percutaneous auricular neurostimulationDEVICE

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.

Active Stimulation
Sham percutaneous auricular neurostimulationDEVICE

Identical in appearance to active, device, but no stimulation will be given.

Sham Percutaneous Neurostimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective colon surgery
  • age over 18 years
  • provide informed consent

You may not qualify if:

  • emergency surgery
  • history of opioid dependence/use, anxiety with anxiolytic use
  • planned ICU admission postoperatively
  • adhesive allergy/sensitivity
  • other medical contraindications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin - Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

  • 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.

    PMID: 33417346DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Results Point of Contact

Title
Carrie Y. Peterson, MD, MS
Organization
Medical College of Wisconsin
cypeterson@mcw.edu
414-955-5783

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 2, 2016

First Posted

September 8, 2016

Study Start

November 1, 2016

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

May 7, 2019

Results First Posted

May 7, 2019

Record last verified: 2019-04

Locations

US(1)