Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-02-27 @ 3:50 PM
Study NCT ID:
NCT02235506
Status:
UNKNOWN
Last Update Posted:
2015-07-16
First Post:
2014-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Epidural Block With Adding Sciatic Block to Continuous Femoral Block in Total Knee Arthroplasty
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-14', 'studyFirstSubmitDate': '2014-09-01', 'studyFirstSubmitQcDate': '2014-09-05', 'lastUpdatePostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of side effects', 'timeFrame': 'during 5 days after the end of operation', 'description': 'Side effects: The patients were asked to their experience of dizziness, sedation, nausea/vomiting (PONV), and pruritus. Urinary retention: bladder volume was measured by ultrasonography and if the volume was more than 400 mL and if the patient was unable to void spontaneously, single catheterization was performed.'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'during 5 days after the end of operation', 'description': 'Pain according to visual analogue scale at rest and on mobilization.'}, {'measure': 'Motor blockade at rest and on mobilization', 'timeFrame': 'during 5 days after the end of operation', 'description': 'Motor blockade is estimated using a modified Bromage scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The investigators compared continuous epidural infusion with combined continuous femoral and single-shot sciatic nerve blocks. The primary outcome was the incidence of side effects, and secondary outcomes were pain relief, motor blockade,morphine consumption, and rehabilitation indices.', 'detailedDescription': 'The parcicipants were randomly assingned to epidural infusion group and femoral sciatic block. In epidural infusion group, a lumbar epidural catheter was placed at the L3-4 level using loss-ofresistance procedure. ropivacaine 0.2% and fentayl 2mcg/ml were infused at a rate of 5ml/hr from the end of operation. In femoral sciatic group, the femoral and sciatic nerve are located using ultrasound and 0.2% ropivacain is injected. A catheter is inserted to femoral nerve. From the end of operation, 0.2% ropivacaine was infused through the femoral catheter at a rate of 5ml/hr. The incidence of side effects is measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists Physical Status Classification I-II\n* total knee arthroplasty\n* 18-90 years\n\nExclusion Criteria:\n\n* allergic to the local anesthetics\n* cognitive impairment such as dementia\n* coagulopathy\n* motor and sensory impairment\n* patient refusal\n* BMI \\>39'}, 'identificationModule': {'nctId': 'NCT02235506', 'briefTitle': 'A Comparison of Epidural Block With Adding Sciatic Block to Continuous Femoral Block in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Yeungnam University College of Medicine'}, 'officialTitle': 'A Comparison of Epidural Analgesia With Adding Sciatic Nerve Block to Continuous Femoral Nerve Block for Post-operative Pain Management Following Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'apsj0901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'epidural infusion', 'description': 'In epidural infusion group, a lumbar epidural catheter was placed at the L3-4 level using loss-ofresistance procedure. ropivacaine 0.2% and fentayl 2mcg/ml were infused at a rate of 5ml/hr from the end of operation,', 'interventionNames': ['Procedure: epidural infusion', 'Device: epidural infusion']}, {'type': 'EXPERIMENTAL', 'label': 'femoral sciatic', 'description': 'In femoral sciatic group, the femoral and sciatic nerve are located using ultrasound and 0.2% ropivacain is injected. A catheter is inserted to femoral nerve. From the end of operation, 0.2% ropivacaine was infused through the femoral catheter at a rate of 5ml/hr.', 'interventionNames': ['Procedure: femoral sciatic', 'Device: femoral sciatic']}], 'interventions': [{'name': 'epidural infusion', 'type': 'PROCEDURE', 'otherNames': ['continuous lumbar epidural block'], 'description': 'Lumbar epidural catheter is placed at the L3-4 level using loss-ofresistance procedure. Fentayl 2mcg/ml and 0.2% ropivacaine are infused at a rate of 5ml/hr.', 'armGroupLabels': ['epidural infusion']}, {'name': 'femoral sciatic', 'type': 'PROCEDURE', 'otherNames': ['femoral nerve block and sciatic nerve block'], 'description': 'After femoral and sciatic nerve are identified using ultrasound, 0.2% ropivacaine 20 mL is injected. A catheter is inserted to femoral nerve and 0.2% ropivacaine is infused through the femoral catheter at a rate of 5ml/hr from the end of surgery.', 'armGroupLabels': ['femoral sciatic']}, {'name': 'epidural infusion', 'type': 'DEVICE', 'otherNames': ['perifix epidural catheter, B-Braoun'], 'description': 'Lumbar epidural catheter is placed at the L3-4 level using loss-ofresistance procedure. Fentayl 2mcg/ml and 0.2% ropivacaine are infused at a rate of 5ml/hr.', 'armGroupLabels': ['epidural infusion']}, {'name': 'femoral sciatic', 'type': 'DEVICE', 'otherNames': ['contiplex catheter and stimuplex needle; B-Braun'], 'description': 'After femoral and sciatic nerve are identified using ultrasound, 0.2% ropivacaine 20 mL is injected. A catheter is inserted to femoral nerve and 0.2% ropivacaine is infused through the femoral catheter at a rate of 5ml/hr from the end of surgery.', 'armGroupLabels': ['femoral sciatic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '705-035', 'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Duckhee Lee, M.D.', 'role': 'CONTACT', 'email': 'apsj0718@naver.com', 'phone': '82-53-620-3365'}, {'name': 'Sangjin Park, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Anesthesiology and Pain Medicine, Yeungnam University hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'centralContacts': [{'name': 'Sangjin Park, M.D.', 'role': 'CONTACT', 'email': 'apsj0718@naver.com', 'phone': '82-53-620-3366'}], 'overallOfficials': [{'name': 'Sangjin Park, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yeungnam University College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Sangjin Park', 'investigatorAffiliation': 'Yeungnam University College of Medicine'}}}}