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

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Device: Percutaneous auricular neurostimulation; Device: Sham percutaneous auricular neurostimulation

• Registration Number: NCT02892513
• Lead Sponsor: Medical College of Wisconsin

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-08
• Study Start: 2016-11
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2019-04
• Results First Submitted: 2019-04-12
• Results First Submitted QC: 2019-04-12
• Last Update Submitted: 2019-04-12
• Results First Posted: 2019-05-07
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Stimulation	Percutaneous auricular neurostimulation	Participants will have active percutaneous auricular neurostimulation for 5 days during and after elective surgery.
Sham Percutaneous Neurostimulation	Sham percutaneous auricular neurostimulation	Participants will have inactive device worn for 5 days during and after elective surgery.

Primary Outcome Measures

Name	Time	Method
Total Narcotic Consumption During Hospital Stay	5 days	Total inpatient narcotic use measured in oral morphine equivalents per day (OME)

Trial Locations

Locations (1)

Medical College of Wisconsin - Froedtert Hospital; 🇺🇸 Milwaukee, Wisconsin, United States