Pain, Postoperative Clinical Trial
Official title:
Auricular Percutaneous Electrical Nerve Field Stimulation for Postoperative Pain Control in Adults
Verified date | April 2019 |
Source | Medical College of Wisconsin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 53 |
Est. completion date | April 30, 2018 |
Est. primary completion date | April 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Medical College of Wisconsin - Froedtert Hospital | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Narcotic Consumption During Hospital Stay | Total inpatient narcotic use measured in oral morphine equivalents per day (OME) | 5 days |
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