Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-02-27 @ 8:48 AM
Study NCT ID:
NCT00560092
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2006-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrathecal Magnesium and Postoperative Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-02', 'studyFirstSubmitDate': '2006-06-22', 'studyFirstSubmitQcDate': '2007-11-16', 'lastUpdatePostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of morphine consumption in the postoperative period.', 'timeFrame': 'in the postoperative period'}], 'secondaryOutcomes': [{'measure': 'Duration of sensory and motor blockade induced by the intrathecal anesthesia ; side effects; postoperative pain (visual analogue scale).', 'timeFrame': 'postoperative pain'}]}, 'conditionsModule': {'keywords': ['Magnesium', 'Pain', 'Morphine', 'Intrathecal', 'NMDA', 'Elective total hip replacement under intrathecal anesthesia'], 'conditions': ['Total Hip Replacement']}, 'referencesModule': {'references': [{'pmid': '2451020', 'type': 'BACKGROUND', 'citation': 'Mayer ML, Westbrook GL. Permeation and block of N-methyl-D-aspartic acid receptor channels by divalent cations in mouse cultured central neurones. J Physiol. 1987 Dec;394:501-27. doi: 10.1113/jphysiol.1987.sp016883.'}, {'pmid': '12198056', 'type': 'BACKGROUND', 'citation': 'Buvanendran A, McCarthy RJ, Kroin JS, Leong W, Perry P, Tuman KJ. Intrathecal magnesium prolongs fentanyl analgesia: a prospective, randomized, controlled trial. Anesth Analg. 2002 Sep;95(3):661-6, table of contents. doi: 10.1097/00000539-200209000-00031.'}]}, 'descriptionModule': {'briefSummary': 'Magnesium is implicated in the activation of NMDA receptors by amino-excitatory acids in the central nervous system \\[1\\]. Magnesium deficiency is associated to an increased activation of these receptors, and to an increased sensitivity to pain in animals. Spinal cord is the site of sensitization of pain, mainly mediated by the NMDA receptors, and intrathecal magnesium may have anti-hyperalgesic effect when administered intrathecally \\[2\\]. As intrathecal magnesium has already been used in humans for treatment of eclampsia, we stated that it could also improve postoperative analgesia and reduce the need for auto-administered morphine if given (50 mg of magnesium sulfate) with the intrathecal anesthetic drugs (bupivacaine and sufentanil) injected for orthopedic surgery.', 'detailedDescription': 'Magnesium is implicated in the activation of NMDA receptors by amino-excitatory acids in the central nervous system \\[1\\]. Magnesium deficiency is associated to an increased activation of these receptors, and to an increased sensitivity to pain in animals. Spinal cord is the site of sensitization of pain, mainly mediated by the NMDA receptors, and intrathecal magnesium may have anti-hyperalgesic effect when administered intrathecally \\[2\\]. As intrathecal magnesium has already been used in humans for treatment of eclampsia, we stated that it could also improve postoperative analgesia and reduce the need for auto-administered morphine if given (50 mg of magnesium sulfate) with the intrathecal anesthetic drugs (bupivacaine and sufentanil) injected for orthopedic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '93 Years', 'minimumAge': '56 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Total hip replacement under intrathecal anesthesia.\n\nExclusion Criteria:\n\n* General anesthesia (alone or not)\n* Intolerance to morphine\n* Misunderstanding of the use of the device for intravenous patient-controlled administration of morphine.'}, 'identificationModule': {'nctId': 'NCT00560092', 'briefTitle': 'Intrathecal Magnesium and Postoperative Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Effects of a Single Dose of Intrathecal Magnesium Sulfate on Postoperative Morphine Consumption After Total Hip Replacement', 'orgStudyIdInfo': {'id': 'CHU63-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intrathecal magnesium sulfate', 'interventionNames': ['Drug: intrathecal magnesium sulfate']}], 'interventions': [{'name': 'intrathecal magnesium sulfate', 'type': 'DRUG', 'description': 'intrathecal magnesium sulfate', 'armGroupLabels': ['intrathecal magnesium sulfate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'state': 'Auvergne', 'country': 'France', 'facility': 'Clermont-Ferrand University Hospital', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Christian Duale, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}