Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-06 @ 6:02 AM
Study NCT ID:
NCT02818894
Status:
TERMINATED
Last Update Posted:
2022-09-23
First Post:
2016-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Spinal Anesthesia in Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tombradburymd@gmail.com', 'phone': '404-759-3912', 'title': 'Thomas L. Bradbury, MD', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study was terminated due to extended suspension of the study related to personnel issues and pandemic-related issues. Missing data due to lost study records limited the number of available data points.'}}, 'adverseEventsModule': {'timeFrame': 'Information on adverse events was collected from the day of surgery through the 14 Days Post-Operative phone call (15 days total).', 'eventGroups': [{'id': 'EG000', 'title': 'Lidocaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bupivacaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 0, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Transient Neurological Symptoms (TNS) on Day 1 Post-Operation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.'}, {'id': 'OG001', 'title': 'Bupivacaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 (day of surgery) Post-Operation', 'description': 'Following a prepared questionnaire, a study team member asked about TNS and pain that was not associated with the operation area. The count of participants reporting any type of TNS is presented here.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed the Neurological Symptoms Checklist. Two participants were assessed for other outcomes post-operatively on day of surgery but TNS was not evaluated. Sixteen participants were not assessed post-operatively on day of surgery for any outcomes, or their records were lost. Details about some study visits are no longer available and the exact reasons for the missing data cannot be determined.'}, {'type': 'PRIMARY', 'title': 'Post-Operative Transient Neurological Symptoms Score on Day 1 Post-Operation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.'}, {'id': 'OG001', 'title': 'Bupivacaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '4', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (day of surgery) Post-Operation', 'description': 'Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain that was not associated with the operation area. Participants were asked to grade the symptoms on a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants reporting any type of TNS following surgery, on the day of surgery.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Transient Neurological Symptoms on Post-Operative Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.'}, {'id': 'OG001', 'title': 'Bupivacaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-Operative Day 7', 'description': 'Following a prepared questionnaire, a study team member asked about TNS and pain that was not associated with the operation area. The count of participants reporting any type of TNS is presented here.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed the Neurological Symptoms Checklist. One participant in the lidocaine group participated in the Post-Operative Day 7 follow-up phone call but did not complete the Neurological Symptoms Checklist. The remaining missing participants were lost to follow up, were not called for this follow-up assessment, or their records were lost. Details about some study visits are no longer available and the exact reasons for missing data cannot be determined.'}, {'type': 'PRIMARY', 'title': 'Transient Neurological Symptoms Score on Post-Operative Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.'}, {'id': 'OG001', 'title': 'Bupivacaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.33', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '5.75', 'spread': '4.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-Operative Day 7', 'description': 'Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain that was not associated with the operation area. Participants were asked to grade the symptoms on a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants reporting any type of TNS during the Post-Operative Day 7 follow-up assessment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Transient Neurological Symptoms on Post-Operative Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.'}, {'id': 'OG001', 'title': 'Bupivacaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-Operative Day 14', 'description': 'Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain not associated with the operation area. The count of participants reporting any type of TNS is presented here.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed the Neurological Symptoms Checklist. Thirteen participants in the Bupivacaine group participated in the Post-Operative Day 14 follow-up phone call but only 12 completed the TNS assessment. The remaining missing participants were lost to follow up, were not called for the Post-Operative Day 14 assessment, or their records were lost. Details about some study visits are no longer available and the exact reasons for missing data cannot be determined.'}, {'type': 'PRIMARY', 'title': 'Transient Neurological Symptoms Score on Post-Operative Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.'}, {'id': 'OG001', 'title': 'Bupivacaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.56', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '5.67', 'spread': '3.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-Operative Day 14', 'description': 'Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain that was not associated with the operation area. Participants were asked to grade the symptoms on a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants reporting any type of TNS following surgery on Post-Operative Day 14.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Voiding Without Complications After Recovery From Spinal Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.'}, {'id': 'OG001', 'title': 'Bupivacaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 (day of surgery) Post-Operation', 'description': 'Urine retention after recovery from spinal anesthesia was assessed as the count of participants voiding without complications. Data were obtained through review of the inpatient records.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who had data regarding urinary voiding recorded. Details about some study visits are no longer available and the exact reasons for missing data cannot be determined.'}, {'type': 'SECONDARY', 'title': 'Time to Ambulation After Recovery From Spinal Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.'}, {'id': 'OG001', 'title': 'Bupivacaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.'}], 'classes': [{'categories': [{'measurements': [{'value': '279.3', 'spread': '273.0', 'groupId': 'OG000'}, {'value': '242.0', 'spread': '91.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (day of surgery) Post-Operation', 'description': 'Time to ambulation after recovery from spinal anesthesia is assessed in minutes. Information about time to full ambulation was obtained by asking participants or from inpatient medical charts.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who had the time when they were fully ambulatory recorded. Details about some study visits are no longer available and the exact reasons for missing data cannot be determined.'}, {'type': 'SECONDARY', 'title': 'Count of Participants With Hypotension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.'}, {'id': 'OG001', 'title': 'Bupivacaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 (day of surgery) Post-Operation', 'description': 'The number of participants experiencing hypotension, defined as systolic blood pressure of \\<90 mmHg, is presented here. Blood pressure information was obtained from reviewing the inpatient medical charts.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants with post-operative blood pressure data recorded. Details about some study visits are no longer available and the exact reasons for missing data cannot be determined.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Discharged 0, 1, or 2 Days Following Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.'}, {'id': 'OG001', 'title': 'Bupivacaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.'}], 'classes': [{'categories': [{'title': 'Day of surgery', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Post-operative Day 1', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Post-operative Day 2', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Post-Operative Day 2', 'description': 'Hospital length of stay was obtained from inpatient charts. Length of stay was determined using the hospital admission dates and discharge dates, and was then categorized as being discharged the same day as the surgery, the day after surgery, or two days after surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants with discharge data collected from medical records. Details about some study visits are no longer available and the exact reasons for missing data cannot be determined.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lidocaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.'}, {'id': 'FG001', 'title': 'Bupivacaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '56'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lidocaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.'}, {'id': 'BG001', 'title': 'Bupivacaine Spinal Anesthesia', 'description': 'Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '61.08', 'spread': '11.056', 'groupId': 'BG000'}, {'value': '61.22', 'spread': '10.98', 'groupId': 'BG001'}, {'value': '61.13', 'spread': '11.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-26', 'size': 2687472, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-19T11:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'whyStopped': 'This study was terminated due to pressing matters related to the COVID-19 pandemic - staff shortages and changes of personnel, data gaps due to the pandemic, participants not being able to continue follow-up visits, and ongoing enrollment issues.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'dispFirstSubmitDate': '2022-01-11', 'completionDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-25', 'studyFirstSubmitDate': '2016-06-28', 'dispFirstSubmitQcDate': '2022-01-11', 'resultsFirstSubmitDate': '2022-08-25', 'studyFirstSubmitQcDate': '2016-06-28', 'dispFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-25', 'studyFirstPostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Transient Neurological Symptoms (TNS) on Day 1 Post-Operation', 'timeFrame': 'Day 1 (day of surgery) Post-Operation', 'description': 'Following a prepared questionnaire, a study team member asked about TNS and pain that was not associated with the operation area. The count of participants reporting any type of TNS is presented here.'}, {'measure': 'Post-Operative Transient Neurological Symptoms Score on Day 1 Post-Operation', 'timeFrame': 'Day 1 (day of surgery) Post-Operation', 'description': 'Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain that was not associated with the operation area. Participants were asked to grade the symptoms on a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort.'}, {'measure': 'Number of Participants With Transient Neurological Symptoms on Post-Operative Day 7', 'timeFrame': 'Post-Operative Day 7', 'description': 'Following a prepared questionnaire, a study team member asked about TNS and pain that was not associated with the operation area. The count of participants reporting any type of TNS is presented here.'}, {'measure': 'Transient Neurological Symptoms Score on Post-Operative Day 7', 'timeFrame': 'Post-Operative Day 7', 'description': 'Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain that was not associated with the operation area. Participants were asked to grade the symptoms on a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort.'}, {'measure': 'Number of Participants With Transient Neurological Symptoms on Post-Operative Day 14', 'timeFrame': 'Post-Operative Day 14', 'description': 'Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain not associated with the operation area. The count of participants reporting any type of TNS is presented here.'}, {'measure': 'Transient Neurological Symptoms Score on Post-Operative Day 14', 'timeFrame': 'Post-Operative Day 14', 'description': 'Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain that was not associated with the operation area. Participants were asked to grade the symptoms on a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Voiding Without Complications After Recovery From Spinal Anesthesia', 'timeFrame': 'Day 1 (day of surgery) Post-Operation', 'description': 'Urine retention after recovery from spinal anesthesia was assessed as the count of participants voiding without complications. Data were obtained through review of the inpatient records.'}, {'measure': 'Time to Ambulation After Recovery From Spinal Anesthesia', 'timeFrame': 'Day 1 (day of surgery) Post-Operation', 'description': 'Time to ambulation after recovery from spinal anesthesia is assessed in minutes. Information about time to full ambulation was obtained by asking participants or from inpatient medical charts.'}, {'measure': 'Count of Participants With Hypotension', 'timeFrame': 'Day 1 (day of surgery) Post-Operation', 'description': 'The number of participants experiencing hypotension, defined as systolic blood pressure of \\<90 mmHg, is presented here. Blood pressure information was obtained from reviewing the inpatient medical charts.'}, {'measure': 'Number of Participants Discharged 0, 1, or 2 Days Following Surgery', 'timeFrame': 'Up to Post-Operative Day 2', 'description': 'Hospital length of stay was obtained from inpatient charts. Length of stay was determined using the hospital admission dates and discharge dates, and was then categorized as being discharged the same day as the surgery, the day after surgery, or two days after surgery.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hip replacement', 'Total hip arthroplasty', 'Anterior total hip replacement', 'Transient neurological symptoms', 'Spinal anesthesia'], 'conditions': ['Total Hip Arthroplasty']}, 'descriptionModule': {'briefSummary': 'Spinal anesthesia is commonly used in patients undergoing total hip replacements. The purpose of this study is to compare lidocaine to bupivacaine spinal anesthesia in patients having a total hip arthroplasty (THA). The objective of this study is to compare the two spinal anesthesia treatments in regards to transient neurological symptoms (TNS).', 'detailedDescription': 'Most surgeons would agree total hip arthroplasty (THA) is one of the most successful surgical interventions. However, when it comes to the type of anesthesia to improve THA outcomes, surgeons do not agree. General anesthesia has been shown to be associated with increases in adverse events, increased operating room times and increased length of stay. Therefore, more surgeons are turning to spinal anesthesia for better pain control, decreased need for narcotics resulting in less nausea, sooner recovery of bowel function, and faster participation in physical therapy. All of these factors can lead to a sooner discharge from the hospital, which would lead to significant cost savings.\n\nTransient neurological symptoms (TNS) are a concern of using spinal anesthesia and have been shown to occur up to 16-40% of the time with lidocaine. Symptoms of TNS have been described as pain, dysesthesia, or both that occur in the legs or buttocks and urinary retention after recovery from spinal anesthesia. Intensity of pain varies but can be quite severe. Symptoms can appear in a few hours, for up to 24 hours after surgery.\n\nLidocaine is the most widely used anesthetic due to its rapid onset, intense nerve blockade, and short duration of action. The risk of developing TNS after spinal anesthesia with lidocaine has been shown to be higher when compared to other anesthetics. However, it is unknown whether there are differences between patients who undergo spinal anesthesia with lidocaine versus bupivacaine in THA. This knowledge is important because it has been shown that bupivacaine spinal anesthesia is more effective than lidocaine with minimal adverse effects. A large randomized, prospective study is needed to prove the difference between the two types of anesthesia.\n\nThe primary objective of this study is to compare TNS among people who receive one of two spinal anesthesia treatments, lidocaine or bupivacaine. The study will be conducted on individuals who are indicated for THA and have agreed to have spinal anesthesia during their surgery. All patients will be randomized by a computer program and will receive either lidocaine or bupivacaine spinal anesthesia prior to their THA. In addition to TNS, other outcomes include urinary retention, hypotension, ambulation and length of hospital stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Radiographic evidence of symptomatic osteoarthritis in one or bilateral hips. Osteoarthritis will be defined as pain with weight-bearing at the hip articulation together with radiographic findings\n* Indicated for total hip arthroplasty\n* Agreement to undergo spinal anesthesia for surgery\n\nExclusion Criteria:\n\n* Patient refusal to undergo spinal anesthesia\n* Patients with a known history of lumbar or sacral spinal fusion.\n* Patients with a known history of prostate, urological, or kidney surgery.\n* Patients who need monitoring of urine output during surgery (including patients with confirmed renal disease, renal failure, chronic renal insufficiency, or an indwelling catheter at the time of surgery).\n* Current infection at site of injection\n* Women of child-bearing potential who are on Medicare (child-bearing potential will be determined prior to surgery per Anesthesia standard of care)\n* Hypovolemia\n* Indeterminate neurologic disease\n* Allergy or hypersensitivity to the study medications\n* Currently taking any anti-coagulation medications or coagulopathic\n* Increased intracranial pressure\n* Subject is unable to make his/her own decision regarding the informed consent\n* Subject is unable to read/understand English'}, 'identificationModule': {'nctId': 'NCT02818894', 'briefTitle': 'Spinal Anesthesia in Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Comparison of Lidocaine Versus Bupivacaine Spinal Anesthesia in Total Hip Arthroplasty: A Randomized, Double-Blind, Prospective Study', 'orgStudyIdInfo': {'id': 'IRB00083867'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine prior to THA', 'description': 'Participants scheduled for Total Hip Arthroplasty through anterior approach with Lidocaine spinal anesthesia and completing telephone questionnaires to see how they are feeling post-operation.', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine prior to THA', 'description': 'Participants scheduled for Total Hip Arthroplasty through anterior approach with Bupivacaine spinal anesthesia and completing telephone questionnaires to see how they are feeling post-operation.', 'interventionNames': ['Drug: Bupivacaine']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'description': "Spinal anesthesia administered prior to participant's THA", 'armGroupLabels': ['Lidocaine prior to THA']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': "Spinal anesthesia administered prior to participant's THA", 'armGroupLabels': ['Bupivacaine prior to THA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Orthopaedic and Spine Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Emory Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Thomas Bradbury, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas L Bradbury', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Thomas L Bradbury', 'investigatorAffiliation': 'Emory University'}}}}