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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active Stimulation

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

Group Type EXPERIMENTAL

Percutaneous auricular neurostimulation

Intervention Type DEVICE

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 Percutaneous Neurostimulation

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

Group Type SHAM_COMPARATOR

Sham percutaneous auricular neurostimulation

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Sham percutaneous auricular neurostimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No