Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-27 @ 5:51 PM
Study NCT ID:
NCT02581566
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2015-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intrathecal vs Intraarticular Dexmedetomidine on Postoperative Pain Following Arthroscopy
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': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-11', 'studyFirstSubmitDate': '2015-10-18', 'studyFirstSubmitQcDate': '2015-10-19', 'lastUpdatePostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pain', 'timeFrame': '24 hours', 'description': 'Assesment is done by Visual Analog Scale'}], 'secondaryOutcomes': [{'measure': 'c-reactive protein', 'timeFrame': '24 hours'}]}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Comparison between intrathecal Dexmedetomidine versus Intraarticular Dexmedetomidine on postoperative pain after knee arthroscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, ASA I-II, undergoing knee arthroscopy under spinal anesthesia.\n\nExclusion Criteria:\n\n* Absolute or relative contraindications to spinal anesthesia, allergy to dexmedetomidine or chronic pain treatment.'}, 'identificationModule': {'nctId': 'NCT02581566', 'briefTitle': 'Effect of Intrathecal vs Intraarticular Dexmedetomidine on Postoperative Pain Following Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'orgStudyIdInfo': {'id': '01003060215'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intrathecal Dexmedetomidine Group', 'description': '30 patients will be given Intrathecal Dexmedetomidine plus Intrathecal Bupivacaine', 'interventionNames': ['Drug: Intrathecal Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intraarticular Dexmedetomidine Group', 'description': '30 patients will be given Intraarticular Dexmedetomidine plus Intrathecal Bupivacaine', 'interventionNames': ['Drug: Intraarticular Dexmedetomidine']}, {'type': 'OTHER', 'label': 'control Group', 'description': '30 patients will be given Intrathecal Bupivacaine', 'interventionNames': ['Drug: Bupivacaine']}], 'interventions': [{'name': 'Intrathecal Dexmedetomidine', 'type': 'DRUG', 'description': 'Addition of Intathecal Dexmedetomidine plus Intrathecal Bupivacaine', 'armGroupLabels': ['Intrathecal Dexmedetomidine Group']}, {'name': 'Intraarticular Dexmedetomidine', 'type': 'DRUG', 'description': 'Addition of Intraarticular Dexmedetomidine plus Intrathecal Bupivacaine', 'armGroupLabels': ['Intraarticular Dexmedetomidine Group']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'Intrathecal Bupivacaine', 'armGroupLabels': ['control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Eman A. Ismail', 'investigatorAffiliation': 'Assiut University'}}}}