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

Primary Purpose

Post Operative Pain, Midline Sternotomy Incision

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Primary Relief v 2.0

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring Cardiac surgery pain reduction, Post operative pain, PENS, Neurostimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sri Jayadeva Institute of cardiovascular Science and Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Primary Relief v 2.0 with Paracetamol

Only Paracetamol

Arm Description

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.

Group B will be treated with paracetamol drug.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03750357

First Posted

November 17, 2018

Last Updated

January 31, 2019

Sponsor

DyAnsys, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03750357

Brief Title

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

Acronym

POPS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

October 11, 2018 (Actual)

Primary Completion Date

November 17, 2018 (Actual)

Study Completion Date

December 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

DyAnsys, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Operative Pain, Midline Sternotomy Incision

Keywords

Cardiac surgery pain reduction, Post operative pain, PENS, Neurostimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare Provider

Allocation

Non-Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Primary Relief v 2.0 with Paracetamol

Arm Type

Experimental

Arm Description

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.

Arm Title

Only Paracetamol

Arm Type

No Intervention

Arm Description

Group B will be treated with paracetamol drug.

Intervention Type

Device

Intervention Name(s)

Primary Relief v 2.0

Other Intervention Name(s)

Neurostimulator

Intervention Description

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

Primary Outcome Measure Information:

Title

PAIN Relief by physical examination by HCP

Description

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.

Time Frame

After 2 hours of device activation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rohini M Balaji, MBBS., DNB

Organizational Affiliation

Sri Jayadeva Institue of Cardiovascular Science and Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sri Jayadeva Institute of cardiovascular Science and Research

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560069

Country

India

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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