Medical College of Wisconsin - Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
NCT Number: NCT02892513
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Milwaukee, Wisconsin, 53226, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Identical in appearance to active, device, but no stimulation will be given.
Time frame: 5 days
Total inpatient narcotic use measured in oral morphine equivalents per day (OME)
Medical College of Wisconsin
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05283980
Acute Pain, Behavior
Boston, Massachusetts, United States
View Trial DetailsNCT05859061
Neurologic Manifestations, Pain
Chicago, Illinois, United States
View Trial DetailsNCT06791577
Blood Coagulation Disorders, Bruising
São Paulo, Brazil
View Trial DetailsNCT03090776
Neurologic Manifestations, Pain
Boston, Massachusetts, United States
View Trial Details