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

NCT03750357 | Completed

• 2 other identifiers: PR2-POPS-18CS/PRv2.0/01/2018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Operative Pain; Midline Sternotomy Incision

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Primary Relief v 2.0 with Paracetamol

EXPERIMENTAL

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

Only Paracetamol

NO INTERVENTION

Group B will be treated with paracetamol drug.

Interventions

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.

Also known as: Neurostimulator

Primary Relief v 2.0 with Paracetamol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cardiac surgery patient with midline sternotomy incision

You may not qualify if:

• 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

Sponsors & Collaborators

• DyAnsys, Inc.: lead

Study Sites (1)

Sri Jayadeva Institute of cardiovascular Science and Research

Bangalore, Karnataka, 560069, India

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Implantable Neurostimulators

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants

Study Officials

• Rohini M Balaji, MBBS., DNB

  Sri Jayadeva Institue of Cardiovascular Science and Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2018
• First Posted: November 23, 2018
• Study Start: October 11, 2018
• Primary Completion: November 17, 2018
• Study Completion: December 17, 2018
• Last Updated: February 4, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)