Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT01303120
Status:
COMPLETED
Last Update Posted:
2015-01-21
First Post:
2011-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Does a Single Shot Femoral Nerve Block Alone Produce Appropriate Pain Relief?
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': 'D016058', 'term': 'Analgesia, Patient-Controlled'}], 'ancestors': [{'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-20', 'studyFirstSubmitDate': '2011-02-20', 'studyFirstSubmitQcDate': '2011-02-23', 'lastUpdatePostDateStruct': {'date': '2015-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of single short femoral nerve block', 'timeFrame': 'Three days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Post-operative Pain']}, 'referencesModule': {'references': [{'pmid': '28178436', 'type': 'DERIVED', 'citation': 'Stav A, Reytman L, Sevi R, Stav MY, Powell D, Dor Y, Dudkiewicz M, Bayadse F, Sternberg A, Soudry M. Femoral versus Multiple Nerve Blocks for Analgesia after Total Knee Arthroplasty. Rambam Maimonides Med J. 2017 Jan 30;8(1):e0006. doi: 10.5041/RMMJ.10281.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the efficacy of the analgesic effect of the preoperative femoral nerve block alone versus combined femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks in patients after TKA in the immediate postoperative period.', 'detailedDescription': 'Bupivacaine will be used for all the nerve blocks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-III\n* Undergoing two TKA\n* Understanding PCA protocol\n\nExclusion Criteria:\n\n* Skin infection near injection site\n* Allergy to local analgesics\n* Peripheral neuropathy\n* Coagulopathy\n* Dementia\n* Proven opioid dependency'}, 'identificationModule': {'nctId': 'NCT01303120', 'briefTitle': 'Does a Single Shot Femoral Nerve Block Alone Produce Appropriate Pain Relief?', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Does a Single Shot Femoral Nerve Block Alone Produce Appropriate Pain Relief After Total Knee Arthroplasty or Should an Addition of Sciatic, Obturator and Lateral Femoral Cutaneous Nerve Blocks be Recommended?', 'orgStudyIdInfo': {'id': '0021-11-HYMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Femoral Nerve Block', 'interventionNames': ['Drug: Femoral Nerve Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combined Nerve Blocks', 'interventionNames': ['Drug: Combined nerve blocks']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patient-controlled analgesia', 'interventionNames': ['Drug: Patient-controlled analgesia']}], 'interventions': [{'name': 'Femoral Nerve Block', 'type': 'DRUG', 'description': 'Preoperative Bupivacaine 0.5%, perineurally as single shot', 'armGroupLabels': ['Femoral Nerve Block']}, {'name': 'Combined nerve blocks', 'type': 'DRUG', 'description': 'Preoperative Bupivacaine 0.5%, perineurally as single shot', 'armGroupLabels': ['Combined Nerve Blocks']}, {'name': 'Patient-controlled analgesia', 'type': 'DRUG', 'description': 'Patient controlled analgesia with morphine', 'armGroupLabels': ['Patient-controlled analgesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'A Stav, MD', 'oldOrganization': 'Hillel Yaffe Medical Center'}}}}