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Completed

NCT Number: NCT03750357

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sri Jayadeva Institute of cardiovascular Science and Research

Bangalore, Karnataka, 560069, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary Relief v 2.0

Device

To prove the effectiveness of Post Operative Pain Solution using Primary relief v 2.0 by Percutaneous Electrical Nerve Stimulation in the auricle.

Other names: Neurostimulator

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

DyAnsys, Inc.

Industry

Registry information

Official study title

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

Acronym: POPS

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 23, 2018
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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