Auricular Percutaneous Electrical Nerve Field Stimulation for Postoperative Pain Control in Adults
Completed · Not applicable · Has a placebo group
Conditions studied: Pain, Postoperative
In brief
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.
Key facts
- Study ID
- NCT02892513
- Run by
- Medical College of Wisconsin
- People needed
- 53
- Starts
- 2016-11-01
- Expected to finish
- 2018-04-30
- Last updated by the study team
- 2019-05-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Medical College of Wisconsin - Froedtert Hospital — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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