Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-01 @ 7:56 AM
Study NCT ID:
NCT03150732
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2017-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systemic Nalbuphine Versus Intravenous Regional Anesthesia
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-18', 'studyFirstSubmitDate': '2017-05-08', 'studyFirstSubmitQcDate': '2017-05-10', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of postoperative Analgesia', 'timeFrame': 'Postoperative 24 hours', 'description': 'minutes'}], 'secondaryOutcomes': [{'measure': 'Diclofenac analgesic consumption', 'timeFrame': 'Postoperative 24 hours', 'description': 'mg'}, {'measure': 'Cortisol level', 'timeFrame': 'Preoperative and at 4 hours after skin incision', 'description': 'Level of cortisone in blood (nmol/L)'}, {'measure': 'Severity of postoperative Pain', 'timeFrame': 'Postoperative 24 hours', 'description': 'Visual Analogue Scale (VAS)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Comparison of systemic nalbuphine versus intravenous regional anesthesia in patients undergoing hand surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective unilateral hand surgery.\n\nExclusion Criteria:\n\n* Patient refusal.\n* Allergy to study medications\n* Body mass index \\> 35 kg/ m2\n* Patients with sickle cell or Reynaud diseases\n* Patients with a history of psychiatric illness or on chronic opioids'}, 'identificationModule': {'nctId': 'NCT03150732', 'briefTitle': 'Systemic Nalbuphine Versus Intravenous Regional Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparison of Systemic Nalbuphine Versus Intravenous Regional Anesthesia', 'orgStudyIdInfo': {'id': '000087273'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Systemic nalbuphine group', 'description': '53 patients will receive nalbuphine systemically', 'interventionNames': ['Drug: Systemic nalbuphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Local nalbuphine group', 'description': '53 patients will receive nalbuphine with local intravenous regional anesthesia (IVRA)', 'interventionNames': ['Drug: Local nalbuphine']}], 'interventions': [{'name': 'Systemic nalbuphine', 'type': 'DRUG', 'description': 'Patients will receive systemic nalbuphine 10 mg', 'armGroupLabels': ['Systemic nalbuphine group']}, {'name': 'Local nalbuphine', 'type': 'DRUG', 'description': 'Patients will receive local nalbuphine 10 mg', 'armGroupLabels': ['Local nalbuphine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71526', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Mohamed H Bakri', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of anesthesia & ICU', 'investigatorFullName': 'Mohamed Bakri', 'investigatorAffiliation': 'Assiut University'}}}}