Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT05947760
Status:
RECRUITING
Last Update Posted:
2025-10-10
First Post:
2023-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnesium as an Adjuvant Agent for Postoperative Pain
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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2023-07-05', 'studyFirstSubmitQcDate': '2023-07-05', 'lastUpdatePostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain as measured by the Visual Analog Scale (VAS)', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year', 'description': 'The VAS is a scale from 0-10 with 0 being no pain and 10 being the worst pain ever'}, {'measure': 'Change in number of narcotic medications consumed as measured by the medical record review', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year'}], 'secondaryOutcomes': [{'measure': 'Change in PROMIS scores', 'timeFrame': '2 weeks, 6 weeks, 3 months, 6 months, 1 year', 'description': 'The PROMIS is a 14 item questionnaire is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. Scores are typically between 20-80, but may be 0-100.'}, {'measure': 'Change in modified Harris Hip Scores (mHHS)', 'timeFrame': '2 weeks, 6 weeks, 3 months, 6 months, 1 year', 'description': 'The mHHS is a scoring system for functional outcomes post periactabular osteotomies that has a scale of 0-100, 0 being the lowest functional outcome and 100 being the highest'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['periacetabular osteotomy', 'IV magnesium sulfate', 'Decreased opioid usage'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'Participants are being asked to participate in this research study because they have elected to undergo periacetabular osteotomy (PAO). This research study is looking at if using IV magnesium during surgery can help to reduce pain after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing periacetabular osteotomy with or without adjuvant hip arthroscopy\n\nExclusion Criteria:\n\n* illiterate or non-English speaking patients\n* patients with 2nd or 3rd degree AV block\n* patients with severe renal insufficiency\n* patients with heart failure\n* patients with bradycardia'}, 'identificationModule': {'nctId': 'NCT05947760', 'briefTitle': 'Magnesium as an Adjuvant Agent for Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Magnesium as an Adjuvant Agent for Postoperative Pain Control Following Periacetabular Osteotomy', 'orgStudyIdInfo': {'id': 'STUDY20230720'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV Magnesium Sulfate adjuvant group', 'description': 'Participants in this group will receive standard-of-care procedures intraoperatively and postoperatively along with IV magnesium sulfate for pain control.', 'interventionNames': ['Drug: IV Magnesium Sulfate']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Participants in this group will receive standard-of-care procedures intraoperatively and post-operatively for pain control.'}], 'interventions': [{'name': 'IV Magnesium Sulfate', 'type': 'DRUG', 'description': 'Participants will receive IV Magnesium Sulfate intraoperatively.', 'armGroupLabels': ['IV Magnesium Sulfate adjuvant group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elika Fanaeian, MS', 'role': 'CONTACT', 'email': 'elika.fanaeian@uhhospitals.org', 'phone': '7608846031'}], 'facility': 'University Hospitals', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Alex Nighswander', 'role': 'CONTACT', 'email': 'Alexander.Nighswander@UHhospitals.org', 'phone': '216-844-3190'}], 'overallOfficials': [{'name': 'Robert Wetzel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopedic Trauma Surgeon', 'investigatorFullName': 'Robert Wetzel, MD', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}