Sri Jayadeva Institute of cardiovascular Science and Research
Bangalore, Karnataka, 560069, India
NCT Number: NCT03750357
Percutaneous Electrical Nerve Stimulation (PENS) of the auricle for acute pain management post cardiac surgery
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Bangalore, Karnataka, 560069, India
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
To prove the effectiveness of Post Operative Pain Solution using Primary relief v 2.0 by Percutaneous Electrical Nerve Stimulation in the auricle.
Other names: Neurostimulator
Time frame: After 2 hours of device activation
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.
DyAnsys, Inc.
Industry
Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Acute Pain Management Post Cardiac Surgery
Acronym: POPS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06546722
Cardiac Surgery, Neurologic Manifestations
Beirut, Lebanon
View Trial DetailsNCT05982392
Neurologic Manifestations, Pain
Karachi, Sindh, Pakistan
View Trial DetailsNCT01307202
Neurologic Manifestations, Pain
Hamilton, Ontario, Canada
View Trial DetailsNCT05374499
Neurologic Manifestations, Pain
Los Angeles, California, United States
View Trial Details