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N/A N=53 Randomized Quadruple-blind Treatment

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

Pain, Postoperative

Enrolled (actual)
53
Serious AEs
3.9%
Results posted
May 2019
Primary outcome: Primary: Total Narcotic Consumption During Hospital Stay — 90.79; 90.30 Oral Morphine Equivalents per day (OME) — p=0.97

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Percutaneous auricular neurostimulation (Device); Sham percutaneous auricular neurostimulation (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Medical College of Wisconsin
Primary completion
Apr 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Total Narcotic Consumption During Hospital Stay
90.79; 90.30 0.97

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02892513). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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