Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Post Operative Pain Solution(POPS) - Cardiac Surgery

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

Detailed Description
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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.

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

Conditions
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Post Operative Pain, Midline Sternotomy Incision

Intervention / Treatment
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* Device: Primary Relief v 2.0


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary Relief v 2.0 with Paracetamol<br>Group A will be treated with Primary Relief v 2.0(1 - 100Hz) sweep stimulation with increase in power of the stimulation for fixed interval of time. | Device: Primary Relief v 2.0<br>* To prove the effectiveness of Post Operative Pain Solution using Primary relief v 2.0 by Percutaneous Electrical Nerve Stimulation in the auricle.<br>* Other names: Neurostimulator;|
| No Intervention: Only Paracetamol<br>Group B will be treated with paracetamol drug. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PAIN Relief by physical examination by HCP | 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. | After 2 hours of device activation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery pain reduction, Post operative pain, PENS, Neurostimulation