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

NCT ID: NCT03750357

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-11
• Study Completion Date: 2018-12-17

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.

Conditions

Post Operative Pain; Midline Sternotomy Incision

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Primary Relief v 2.0 with Paracetamol

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 Type: EXPERIMENTAL

Primary Relief v 2.0

Intervention Type: DEVICE

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

Only Paracetamol

Group B will be treated with paracetamol drug.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Primary Relief v 2.0

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

Intervention Type: DEVICE

Other Intervention Names

Neurostimulator

Eligibility Criteria

Inclusion Criteria

• Cardiac surgery patient with midline sternotomy incision

Exclusion Criteria

1. Thoracotomy incisions

2. Patients with pacemakers,

3. Post operative cognitive dysfunction

4. Anticipated ventilation > 24 hrs

5. Pre operative opioid therapy

6. Ear infections

7. Skin lesions / allergy to adhesive materials

8. Re-exploration for any reason

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DyAnsys, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rohini M Balaji, MBBS., DNB

Role: PRINCIPAL_INVESTIGATOR

Sri Jayadeva Institue of Cardiovascular Science and Research

Locations

Sri Jayadeva Institute of cardiovascular Science and Research

Bangalore, Karnataka, India

Countries

India

Other Identifiers

CS/PRv2.0/01/2018

Identifier Type: OTHER

Identifier Source: secondary_id

PR2-POPS-18

Identifier Type: -

Identifier Source: org_study_id