Status:
COMPLETED
Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Post Operative Pain Solution(POPS) - Cardiac Surgery
Lead Sponsor:
DyAnsys, Inc.
Conditions:
Post Operative Pain
Midline Sternotomy Incision
Eligibility:
All Genders
18-65 years
Phase:
NA
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 es...
Eligibility Criteria
Inclusion
- Cardiac surgery patient with midline sternotomy incision
Exclusion
- 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
Key Trial Info
Start Date :
October 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03750357
Start Date
October 11 2018
End Date
December 17 2018
Last Update
February 4 2019
Active Locations (1)
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1
Sri Jayadeva Institute of cardiovascular Science and Research
Bangalore, Karnataka, India, 560069