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

Medical College of Wisconsin

Status: Completed

Conditions: Pain, Postoperative

Treatments: Device: Percutaneous auricular neurostimulation; Device: Sham percutaneous auricular neurostimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02892513

PRO00027872

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

53 participants in 2 patient groups

Active Stimulation

Experimental group

Description:

Participants will have active percutaneous auricular neurostimulation for 5 days during and after elective surgery.

Treatment:

Device: Percutaneous auricular neurostimulation

Sham Percutaneous Neurostimulation

Sham Comparator group

Description:

Participants will have inactive device worn for 5 days during and after elective surgery.

Treatment:

Device: Sham percutaneous auricular neurostimulation