Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT03623035
Status:
COMPLETED
Last Update Posted:
2019-10-23
First Post:
2018-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pain and Sensation After Regional Anesthesia - Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chedward@wakehealth.edu', 'phone': '3367168222', 'title': 'Christopher Edwards', 'organization': 'Wake Forest Baptist Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for 30 days after the day of surgery for each patient.', 'description': 'No patients experienced adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Lumbar Plexus Block Group', 'description': 'This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Pain Score With Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lumbar Plexus Block Group', 'description': 'This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Hours post block placement', 'description': 'Pain scores will be measured on a verbal pain score when participant sits up in bed. Totals Score range 0-10. Lower scores denote better outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Pain Scores at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lumbar Plexus Block Group', 'description': 'This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Hours post block placement', 'description': 'Pain scores will be measured, when the patient is laying still in bed, on a verbal pain scale. Totals Score range 0-10. Lower scores denote better outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Pin Prick Sensation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lumbar Plexus Block Group', 'description': 'This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Hours post block placement', 'description': 'Assessment for spinal resolution below the level of L5/S1 by assessing the presence of pin prick sensation at these levels.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients who had pin prick sensation at the level of L5/S1 6 hours after nerve block and spinal placement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lumbar Plexus Block Group', 'description': 'This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lumbar Plexus Block Group', 'description': 'This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2018-07-30', 'size': 196646, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-21T11:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-21', 'studyFirstSubmitDate': '2018-08-06', 'resultsFirstSubmitDate': '2018-10-08', 'studyFirstSubmitQcDate': '2018-08-06', 'lastUpdatePostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-25', 'studyFirstPostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Pain Score With Activity', 'timeFrame': '6 Hours post block placement', 'description': 'Pain scores will be measured on a verbal pain score when participant sits up in bed. Totals Score range 0-10. Lower scores denote better outcomes.'}], 'secondaryOutcomes': [{'measure': 'Patient Pain Scores at Rest', 'timeFrame': '6 Hours post block placement', 'description': 'Pain scores will be measured, when the patient is laying still in bed, on a verbal pain scale. Totals Score range 0-10. Lower scores denote better outcomes.'}, {'measure': 'Number of Participants Reporting Pin Prick Sensation', 'timeFrame': '6 Hours post block placement', 'description': 'Assessment for spinal resolution below the level of L5/S1 by assessing the presence of pin prick sensation at these levels.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lumbar Plexus block', 'total hip arthroplasty', 'Arthroplasty, direct anterior approach', 'Pain'], 'conditions': ['Anesthesia, Conduction', 'Osteoarthritis, Hip']}, 'referencesModule': {'references': [{'pmid': '8245054', 'type': 'BACKGROUND', 'citation': 'Laupacis A, Bourne R, Rorabeck C, Feeny D, Wong C, Tugwell P, Leslie K, Bullas R. The effect of elective total hip replacement on health-related quality of life. J Bone Joint Surg Am. 1993 Nov;75(11):1619-26. doi: 10.2106/00004623-199311000-00006.'}, {'pmid': '28662957', 'type': 'BACKGROUND', 'citation': 'Zhao HY, Kang PD, Xia YY, Shi XJ, Nie Y, Pei FX. Comparison of Early Functional Recovery After Total Hip Arthroplasty Using a Direct Anterior or Posterolateral Approach: A Randomized Controlled Trial. J Arthroplasty. 2017 Nov;32(11):3421-3428. doi: 10.1016/j.arth.2017.05.056. Epub 2017 Jun 8.'}, {'pmid': '12032037', 'type': 'BACKGROUND', 'citation': "Capdevila X, Macaire P, Dadure C, Choquet O, Biboulet P, Ryckwaert Y, D'Athis F. Continuous psoas compartment block for postoperative analgesia after total hip arthroplasty: new landmarks, technical guidelines, and clinical evaluation. Anesth Analg. 2002 Jun;94(6):1606-13, table of contents. doi: 10.1097/00000539-200206000-00045."}, {'pmid': '25157041', 'type': 'BACKGROUND', 'citation': 'Post ZD, Orozco F, Diaz-Ledezma C, Hozack WJ, Ong A. Direct anterior approach for total hip arthroplasty: indications, technique, and results. J Am Acad Orthop Surg. 2014 Sep;22(9):595-603. doi: 10.5435/JAAOS-22-09-595.'}, {'pmid': '15108988', 'type': 'BACKGROUND', 'citation': 'Williams BA, Kentor ML, Vogt MT, Vogt WB, Coley KC, Williams JP, Roberts MS, Chelly JE, Harner CD, Fu FH. Economics of nerve block pain management after anterior cruciate ligament reconstruction: potential hospital cost savings via associated postanesthesia care unit bypass and same-day discharge. Anesthesiology. 2004 Mar;100(3):697-706. doi: 10.1097/00000542-200403000-00034.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to determine spinal resolution and pain levels after the placement of a lumbar plexus block (LPB) and spinal for total hip replacement procedure. This is a pilot study that looks to collect information in order to design a larger, more significant study comparing Quadratus Lumborum blocks (QLB) and Lumbar Plexus blocks.', 'detailedDescription': 'The Quadratus Lumborum block (QLB) is a newer regional analgesic technique that may be as effective as Lumbar Plexus blocks (LPB) at providing pain control following direct anterior approach (DAA) hip arthroplasty. The purpose of this study is to collect pilot data to help the design of a future randomized study, comparing a QLB to a LPB for DAA procedures. The investigators will assess for spinal resolution below the level of L5/S1 by assessing the presence of pin prick sensation at these levels. This will help determine if pain scores collected at 6hrs reflect analgesia provided by the preoperative LPB alone or if the data is confounded by the presence of spinal anesthesia. This data will help us determine if 6hrs is a feasible primary endpoint to assess pain scores. Additionally, assuming that spinal regression is complete by 6hrs, the VAS pain scores obtained will then be used to perform a power analysis to determine the necessary study size when comparing QLB to LPB for DAA hip arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Total Hip Arthroplasty surgeries at Davie Medical Center of Wake Forest Baptist Health.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that have elective total hip arthroplasty with DAA at Davie Medical Center.\n\nExclusion Criteria:\n\n* Patients will be excluded if they do not receive a lumbar plexus block and spinal anesthesia.\n* and/or if they have peripheral neuropathy affecting their feet.'}, 'identificationModule': {'nctId': 'NCT03623035', 'briefTitle': 'Pain and Sensation After Regional Anesthesia - Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Pilot Study on Pain and Sensation After Regional Anesthesia for Total Hip Arthroplasty', 'orgStudyIdInfo': {'id': 'IRB00052579'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lumbar Plexus block Group', 'description': 'This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27006', 'city': 'Bermuda Run', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Davie Medical Center', 'geoPoint': {'lat': 36.00375, 'lon': -80.422}}], 'overallOfficials': [{'name': 'Christopher J Edwards, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}