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

Post Operative Pain Clinical Trial

— POPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03750357
• Other study ID #: PR2-POPS-18
• Secondary ID: CS/PRv2.0/01/201
• Status: Completed
• Phase: N/A
• Start date: October 11, 2018
• Est. completion date: December 17, 2018

Study information

• Verified date: November 2018
• Source: DyAnsys, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 17, 2018
• Est. primary completion date: November 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Midline Sternotomy Incision
• Pain, Postoperative
• Post Operative Pain

Intervention

Device:
• 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.

Locations

Country	Name	City	State
India	Sri Jayadeva Institute of cardiovascular Science and Research	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
DyAnsys, Inc.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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