Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-03-13 @ 10:39 PM
Study NCT ID:
NCT03106818
Status:
COMPLETED
Last Update Posted:
2017-11-22
First Post:
2017-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Pain Alleviation in Open Heart 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': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D000779', 'term': 'Anesthetics, Local'}, {'id': 'D000277', 'term': 'Adjuvants, Pharmaceutic'}, {'id': 'D003226', 'term': 'Congresses as Topic'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D020910', 'term': 'Ketorolac'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D010592', 'term': 'Pharmaceutic Aids'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'pain control in the early postoperative period'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-21', 'studyFirstSubmitDate': '2017-04-04', 'studyFirstSubmitQcDate': '2017-04-07', 'lastUpdatePostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pain', 'timeFrame': '48 hours postoperative', 'description': 'Vas Scale'}], 'secondaryOutcomes': [{'measure': 'extubation time', 'timeFrame': '48 hours', 'description': 'time to separate patient from mechanical ventilation and extubation'}, {'measure': 'Fentanyl consumption', 'timeFrame': '48 hours', 'description': 'total fenatnyl consumption'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Open Heart Surgery', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Effective pain relief after cardiac surgery has assumed importance with the introduction of fast track discharge protocols that requires early weaning from mechanical ventilation. Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of atelectasis, and prolongs recovery. Infiltration of local anesthetics near the surgical wound has shown to improve early postoperative pain in various surgical procedures.\n\nMagnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in animal and human models of pain.', 'detailedDescription': 'Effective pain relief after cardiac surgery has assumed importance with the introduction of fast track discharge protocols that requires early weaning from mechanical ventilation. Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of atelectasis, and prolongs recovery.\n\nA major cause of pain after cardiac surgery is the median sternotomy particularly on the first two postoperative days.\n\nThe most often used analgesics in these patients are parenteral opioids which can lead to undesirable side-effects as sedation, respiratory depression, nausea, and vomiting.\n\nInfiltration of local anesthetics near the surgical wound has shown to improve early postoperative pain in various surgical procedures.\n\nMagnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in animal and human models of pain.\n\nIt has been mentioned in a systematic review that it may be worthwhile to further study the role of supplemental magnesium in providing perioperative analgesia, because this is a relatively harmless molecule, is not expensive and also because the biological basis for its potential antinociceptive effect is promising.\n\nThese effects are primarily based on physiological calcium antagonism, that is voltage-dependent regulation of calcium influx into the cell, and noncompetitive antagonism of N-methyl-D-aspartate (NMDA) receptors.\n\nthere is a need to evaluate and compare local magnesium with bupivacaine , in comparison to bupivacain ,and other conventional intarvenous analgesics'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Criteria:\n\nInclusion Criteria:\n\n* 18-60 years old\n* American Society of Anesthesiologists physical status II and III\n* Patients scheduled for open heart valve replacement surgery with sternotomy\n\nExclusion Criteria:\n\n* Emergency surgery\n* Clinically significant kidney or liver disease\n* Patients allergic to local anesthetic\n* Patients with prolonged CPB time (\\>120 min)\n* Patients required intra-aortic balloon pump'}, 'identificationModule': {'nctId': 'NCT03106818', 'briefTitle': 'Postoperative Pain Alleviation in Open Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Postoperative Pain Alleviation in Patients Undergoing Cardiac Surgery; Presternal Bupivacaine and Magnesium Infiltration Versus Conventional Intravenous Analgesia', 'orgStudyIdInfo': {'id': 'IRB00009911'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A', 'description': '( bupivacain 0.125% magnesium sulfate 5%) infusion in the presternum , for 48 hours', 'interventionNames': ['Drug: bupivacain with magnesium sulphate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B', 'description': 'bupivacaine 0.125% infusion in the presternum , for 48 hours', 'interventionNames': ['Drug: Bupivacaine only']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'will be conventional , will receive postoperative fentanyl , paracetamol , and ketorolac.', 'interventionNames': ['Drug: conventional']}], 'interventions': [{'name': 'bupivacain with magnesium sulphate', 'type': 'DRUG', 'otherNames': ['local anesthetic with adjuvant for 48 hours'], 'description': 'will receive bupivacain 0.125% and magnesium sulphate 5% infusion in the presternum , for 48 hours', 'armGroupLabels': ['group A']}, {'name': 'Bupivacaine only', 'type': 'DRUG', 'otherNames': ['local anesthetic'], 'description': 'will receive bupivacain 0.125% infusion in the presternum , for 48 hours', 'armGroupLabels': ['group B']}, {'name': 'conventional', 'type': 'DRUG', 'otherNames': ['paracetamol , Ketorolac'], 'description': 'only conventional post operative analgesics will be used', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Emad Zarief Kamel Said', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Emad Kamel Said, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthesia departement , Faculty of Medicine , Assiut university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anesthesia and ICU', 'investigatorFullName': 'Emad Zarief , MD', 'investigatorAffiliation': 'Assiut University'}}}}