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Clinical Trials/NCT03750357
NCT03750357
Completed
Not Applicable

Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Acute Pain Management Post Cardiac Surgery

DyAnsys, Inc.1 site in 1 country60 target enrollmentOctober 11, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post Operative Pain
Sponsor
DyAnsys, Inc.
Enrollment
60
Locations
1
Primary Endpoint
PAIN Relief by physical examination by HCP
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Percutaneous Electrical Nerve Stimulation (PENS) of the auricle for acute pain management post cardiac surgery

Detailed Description

A well formulated analgesic protocol is fundamental to fast tracking post cardiac surgery. Traditional analgesic methods have their own set of drawbacks unique to cardiac surgery. Opioids have well established side effects like nausea, vomiting, respiratory depression, urinary retention. Regional anesthetic techniques in anti coagulated patients may result in potentially catastrophic neurological, bleeding and thromboembolic sequelae. Non steroidal Anti Inflammatory Drugs (NSAIDs) have been associated with increased cerebrovascular events, renal dysfunction, sternal wound infections. These make alternative therapies, including non pharmacological modalities, attractive options for optimal analgesic therapy during the post operative period. Alternative methods like topical application of COX -2 inhibitors, intravenous magnesium, Transcutaneous Electrical Nerve Stimulation (TENS) have been tried with varied results in cardiac surgery. A somatotopic relationship has been described between the auricle and the other anatomical regions of the body. When specific points are accurately identified along the meridians of the ear and stimulated electrically, analgesic effects are known to occur. Percutaneous Electrical Nerve Stimulation (PENS) of the auricle and its efficacy in management of post midline sternotomy pain has not been evaluated previously. Primary Relief v 2.0 is a device which provides continuous PENS aimed at non pharmacological post operative pain management.

Registry
clinicaltrials.gov
Start Date
October 11, 2018
End Date
December 17, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Cardiac surgery patient with midline sternotomy incision

Exclusion Criteria

  • Thoracotomy incisions
  • Patients with pacemakers,
  • Post operative cognitive dysfunction
  • Anticipated ventilation \> 24 hrs
  • Pre operative opioid therapy
  • Ear infections
  • Skin lesions / allergy to adhesive materials
  • Re-exploration for any reason

Outcomes

Primary Outcomes

PAIN Relief by physical examination by HCP

Time Frame: After 2 hours of device activation

Relief of pain when the dosage of the anesthesia level gradually decreases after the surgery completion. This is measured by physical interaction with the patient by the health care provider.

Study Sites (1)

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