Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-28 @ 11:34 AM
Study NCT ID:
NCT00934661
Status:
TERMINATED
Last Update Posted:
2018-09-12
First Post:
2009-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Low Dose Extended-release Epidural and Lumbar Plexus Block Compared to Lumbar Plexus Block for Total Hip Resurfacing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '336-716-7180', 'title': 'Dr. Pamela Nagle Assistant Professor', 'organization': 'Anesthesiology'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Extended Release Epidural Morphine', 'description': 'Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline\n\nExtended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Group', 'description': 'The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush\n\nPlacebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypotension', 'notes': 'Subject experienced hypotension during the operative period, continued to experience hypotension during the immediate recovery period and continued on the neosynephrine infusion as well as receiving blood products and colloids for fluid resuscitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Hypotension'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Length of Hospital Stay After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended Release Epidural Morphine', 'description': 'Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline\n\nExtended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush\n\nPlacebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush'}], 'classes': [{'categories': [{'measurements': [{'value': '2.26', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '2.51', 'spread': '2.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From surgery day to hospital discharge, up to 4 days', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended Release Epidural Morphine', 'description': 'Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline\n\nExtended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush\n\nPlacebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours', 'description': 'Postoperatively, the patients were observed in the post anesthesia care unit (PACU) until regression of sensory levels is demonstrated. They were provided an intravenous (IV) Patient Controlled Analgesia (PCA) and instructions in its use. Morphine 1mg/ml at standard PCA settings (1.5 ml dose, 10 minute lockout interval, 6 ml hourly limit, no basal infusion) were used for postoperative analgesia until discharge plans were made. (Morphine doses were increased in 0.5ml dose increments if the patients were not achieving adequate analgesia.)', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected on Extended Release Epidural Morphine group'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended Release Epidural Morphine', 'description': 'Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline\n\nExtended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush\n\nPlacebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush'}], 'classes': [{'title': 'Total Mean and Standard Deviation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.03', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '8.58', 'spread': '1.49', 'groupId': 'OG001'}]}]}, {'title': 'Post Day 1 Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.12', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '8.53', 'spread': '1.28', 'groupId': 'OG001'}]}]}, {'title': 'Post Day 2 Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.76', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '8.94', 'spread': '1.29', 'groupId': 'OG001'}]}]}, {'title': 'Post Day 3 Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.06', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '8.33', 'spread': '1.57', 'groupId': 'OG001'}]}]}, {'title': 'Post Day 4 Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.18', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '8.56', 'spread': '1.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours', 'description': 'Verbal satisfaction scores (0-10), higher scores represent better outcomes. Scores will be obtained from patients for 96 hours after surgery.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '17 participants in the Extended Release Epidural Morphine group and 18 participants in the placebo group provided Verbal satisfaction scores'}, {'type': 'SECONDARY', 'title': 'Distance Walked at Walking Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended Release Epidural Morphine', 'description': 'Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline\n\nExtended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush\n\nPlacebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush'}], 'classes': [{'title': 'Post Surgery Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '168.1', 'spread': '164.2', 'groupId': 'OG000'}, {'value': '109.8', 'spread': '117.9', 'groupId': 'OG001'}]}]}, {'title': 'Post Surgery Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '206.7', 'spread': '97.1', 'groupId': 'OG000'}, {'value': '143.5', 'spread': '97.4', 'groupId': 'OG001'}]}]}, {'title': 'Post Surgery Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '200.0', 'spread': '70.7', 'groupId': 'OG000'}, {'value': '175.0', 'spread': '132.8', 'groupId': 'OG001'}]}]}, {'title': 'Post Surgery Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'spread': '141.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours', 'description': 'Distance walked at walking test. Longer distance walked represent better outcomes', 'unitOfMeasure': 'Steps', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Different amount of observations were different at each visit. Data for Post Surgery Day 4 for the "Extended Release Epidural Morphine" was not collected.'}, {'type': 'SECONDARY', 'title': 'Verbal Pain Scores Post-gait', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended Release Epidural Morphine', 'description': 'Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline\n\nExtended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush\n\nPlacebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush'}], 'classes': [{'title': 'Pain Score Active', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.44', 'spread': '2.94', 'groupId': 'OG000'}, {'value': '7.16', 'spread': '2.13', 'groupId': 'OG001'}]}]}, {'title': 'Pain Score at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.35', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '3.58', 'spread': '2.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day post surgery', 'description': 'Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '16 participants were analyzed in both the Extended Release Epidural Morphine and the Placebo Group for active pain scores. 17 participants overall were analyzed for the Extended Release Epidural Morphine and 18 participants overall were analyzed for the Placebo Group.'}, {'type': 'SECONDARY', 'title': 'Verbal Pain Scores Post-gait', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended Release Epidural Morphine', 'description': 'Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline\n\nExtended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush\n\nPlacebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush'}], 'classes': [{'title': 'Pain Score Active', 'categories': [{'measurements': [{'value': '5.29', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '5.24', 'spread': '2.28', 'groupId': 'OG001'}]}]}, {'title': 'Pain Score at Rest', 'categories': [{'measurements': [{'value': '2.35', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '2.41', 'spread': '1.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 Days Post Surgery', 'description': 'Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Verbal Pain Scores Post-gait', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended Release Epidural Morphine', 'description': 'Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline\n\nExtended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush\n\nPlacebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush'}], 'classes': [{'title': 'Pain Score Active', 'categories': [{'measurements': [{'value': '4.18', 'spread': '2.48', 'groupId': 'OG000'}, {'value': '5.06', 'spread': '2.29', 'groupId': 'OG001'}]}]}, {'title': 'Pain Score at Rest', 'categories': [{'measurements': [{'value': '2.59', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '2.78', 'spread': '2.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 Days Post Surgery', 'description': 'Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Verbal Pain Scores Post-gait', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended Release Epidural Morphine', 'description': 'Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline\n\nExtended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush\n\nPlacebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush'}], 'classes': [{'title': 'Pain Score Active', 'categories': [{'measurements': [{'value': '3.59', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '2.56', 'groupId': 'OG001'}]}]}, {'title': 'Pain Score at Rest', 'categories': [{'measurements': [{'value': '1.88', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '2.94', 'spread': '2.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 Days Post Surgery', 'description': 'Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Extended Release Epidural Morphine', 'description': 'Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline\n\nExtended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': 'The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush\n\nPlacebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Failure of Combined/Spinal Epidural', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Extended Release Epidural Morphine', 'description': 'Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline\n\nExtended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush\n\nPlacebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'whyStopped': 'Drug was discontinued by manufacturer', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2009-07-02', 'resultsFirstSubmitDate': '2017-11-16', 'studyFirstSubmitQcDate': '2009-07-07', 'lastUpdatePostDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-14', 'studyFirstPostDateStruct': {'date': '2009-07-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of Hospital Stay After Surgery', 'timeFrame': 'From surgery day to hospital discharge, up to 4 days'}], 'secondaryOutcomes': [{'measure': 'Total Opioid Consumption', 'timeFrame': '96 hours', 'description': 'Postoperatively, the patients were observed in the post anesthesia care unit (PACU) until regression of sensory levels is demonstrated. They were provided an intravenous (IV) Patient Controlled Analgesia (PCA) and instructions in its use. Morphine 1mg/ml at standard PCA settings (1.5 ml dose, 10 minute lockout interval, 6 ml hourly limit, no basal infusion) were used for postoperative analgesia until discharge plans were made. (Morphine doses were increased in 0.5ml dose increments if the patients were not achieving adequate analgesia.)'}, {'measure': 'Patient Satisfaction Score', 'timeFrame': '96 hours', 'description': 'Verbal satisfaction scores (0-10), higher scores represent better outcomes. Scores will be obtained from patients for 96 hours after surgery.'}, {'measure': 'Distance Walked at Walking Test', 'timeFrame': '96 hours', 'description': 'Distance walked at walking test. Longer distance walked represent better outcomes'}, {'measure': 'Verbal Pain Scores Post-gait', 'timeFrame': '1 day post surgery', 'description': 'Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.'}, {'measure': 'Verbal Pain Scores Post-gait', 'timeFrame': '2 Days Post Surgery', 'description': 'Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.'}, {'measure': 'Verbal Pain Scores Post-gait', 'timeFrame': '3 Days Post Surgery', 'description': 'Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.'}, {'measure': 'Verbal Pain Scores Post-gait', 'timeFrame': '4 Days Post Surgery', 'description': 'Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hip resurfacing', 'hip arthroplasty'], 'conditions': ['Hip Arthroplasty']}, 'descriptionModule': {'briefSummary': 'At Wake Forest University, the investigators have been using Extended Release Epidural Morphine (EREM), since late 2004, as part of multimodal analgesia in patients having gynecologic surgeries and hip arthroplasties.\n\nHypothesis:\n\nIn patients undergoing a Birmingham total hip arthroplasty (BHA), low dose EREM in conjunction with lumbar plexus block (LPB) will be better than lumbar plexus block alone in increasing proportion of patients who meet discharge criteria within 24 hours.', 'detailedDescription': 'Extended release epidural morphine (EREM, DepoDur®: Endo Pharmaceuticals, Chadds Ford PA) has been studied and increasingly utilized as a method to allow for the improved post-operative analgesia of epidural analgesia without infusions.\n\nAt Wake Forest University, the investigators have been using EREM, since late 2004, as part of multimodal analgesia in patients having gynecologic surgeries and hip arthroplasties. The investigators initially decreased our dosages from those recommended (15 mg for lower extremity surgery and 10-15 mg for abdominal surgery), because side effects (nausea, vomiting and hypotension) were felt to be limiting to recovery. The investigators now use 4-7.5 mg in most patients, with 7.5 mg being the exception and have achieved better results. For hip arthroplasties, the investigators currently use 4-5 mg and have performed two retrospective chart reviews on this use; both suggesting that this approach is efficacious. However, these doses have not been studied in a prospective, randomized, double blind trial. The investigators would like to evaluate the efficacy of this dose of EREM used as part of a multimodal regimen. The investigators will compare EREM 4 mg with lumbar plexus block versus lumbar plexus block alone, (providing the rest of our multimodal approach for both patients).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A primary unilateral Birmingham hip arthroplasty\n* Men and women 18-65 years\n\nExclusion Criteria:\n\n* Refusal of regional anesthesia\n* Laboratory evidence of coagulopathy (platelet count less than 100,000 cells/microliter of blood, prothrombin time greater than 12.1 seconds, partial thromboplastin time greater than 30 seconds, or international normalized ratio of greater than 1.5)\n* Allergy to morphine\n* Obstructive sleep apnea\n* Body mass index (BMI) greater than 40 kg/m2\n* Pregnant or lactating\n* Severe renal or hepatic disease'}, 'identificationModule': {'nctId': 'NCT00934661', 'briefTitle': 'Low Dose Extended-release Epidural and Lumbar Plexus Block Compared to Lumbar Plexus Block for Total Hip Resurfacing', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Low Dose Extended-release Epidural Morphine in Conjunction With Lumbar Plexus Block Versus Lumbar Plexus Block Alone for Total Hip Resurfacing Arthroplasty: A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'IRB00006969'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extended Release Epidural Morphine', 'description': 'Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline', 'interventionNames': ['Drug: Extended Release Epidural Morphine (EREM)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Extended Release Epidural Morphine (EREM)', 'type': 'DRUG', 'otherNames': ['Depodur'], 'description': 'A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline', 'armGroupLabels': ['Extended Release Epidural Morphine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['preservative free normal saline', 'sodium chloride'], 'description': 'A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Pamela C Nagle, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University', 'class': 'OTHER'}, 'collaborators': [{'name': 'EKR Therapeutics, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}