CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 53 enrolled
Drug / intervention
Percutaneous auricular neurostimulation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02892513
NCT02892513N/ACompleted

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

Medical College of Wisconsin·interventional·Posted Sep 8, 2016·Updated May 7, 2019

In Brief

A clinical study evaluating Percutaneous auricular neurostimulation and Sham percutaneous auricular neurostimulation for Pain, Postoperative. Completed, enrolled 53 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 8, 2016
Enrollment StartNov 1, 2016
Primary CompletionApr 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.8 years ago

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.

Sham percutaneous auricular neurostimulationdevice

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