Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-30 @ 6:50 PM
Study NCT ID:
NCT03750357
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2018-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Post Operative Pain Solution(POPS) - Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058542', 'term': 'Implantable Neurostimulators'}], 'ancestors': [{'id': 'D004567', 'term': 'Electrodes, Implanted'}, {'id': 'D004566', 'term': 'Electrodes'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2018-11-17', 'studyFirstSubmitQcDate': '2018-11-20', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PAIN Relief by physical examination by HCP', 'timeFrame': 'After 2 hours of device activation', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac surgery pain reduction', 'Post operative pain', 'PENS', 'Neurostimulation'], 'conditions': ['Post Operative Pain', 'Midline Sternotomy Incision']}, 'descriptionModule': {'briefSummary': 'Percutaneous Electrical Nerve Stimulation (PENS) of the auricle for acute pain management post cardiac surgery', 'detailedDescription': '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.\n\nAlternative 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cardiac surgery patient with midline sternotomy incision\n\nExclusion Criteria:\n\n1. Thoracotomy incisions\n2. Patients with pacemakers,\n3. Post operative cognitive dysfunction\n4. Anticipated ventilation \\> 24 hrs\n5. Pre operative opioid therapy\n6. Ear infections\n7. Skin lesions / allergy to adhesive materials\n8. Re-exploration for any reason'}, 'identificationModule': {'nctId': 'NCT03750357', 'acronym': 'POPS', 'briefTitle': 'Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Post Operative Pain Solution(POPS) - Cardiac Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'DyAnsys, Inc.'}, 'officialTitle': 'Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Acute Pain Management Post Cardiac Surgery', 'orgStudyIdInfo': {'id': 'PR2-POPS-18'}, 'secondaryIdInfos': [{'id': 'CS/PRv2.0/01/2018', 'type': 'OTHER', 'domain': 'Dyansys India'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Primary Relief v 2.0 with Paracetamol', 'description': '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.', 'interventionNames': ['Device: Primary Relief v 2.0']}, {'type': 'NO_INTERVENTION', 'label': 'Only Paracetamol', 'description': 'Group B will be treated with paracetamol drug.'}], 'interventions': [{'name': 'Primary Relief v 2.0', 'type': 'DEVICE', 'otherNames': ['Neurostimulator'], 'description': 'To prove the effectiveness of Post Operative Pain Solution using Primary relief v 2.0 by Percutaneous Electrical Nerve Stimulation in the auricle.', 'armGroupLabels': ['Primary Relief v 2.0 with Paracetamol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560069', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Sri Jayadeva Institute of cardiovascular Science and Research', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}], 'overallOfficials': [{'name': 'Rohini M Balaji, MBBS., DNB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sri Jayadeva Institue of Cardiovascular Science and Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DyAnsys, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}