Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2026-01-03 @ 7:23 PM
Study NCT ID:
NCT03758261
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2018-11-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Erector Spinae Plane vs. Paravertebral Nerve Block for Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lukecb@upmc.edu', 'phone': '4127485589', 'title': 'Dr. Charles Luke', 'organization': 'University of Pittsburgh Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected from time of admission until patient discharge, an average of 4-days.', 'eventGroups': [{'id': 'EG000', 'title': 'Erector Spinae Nerve Block', 'description': 'Erector Spinae nerve block\n\nErector Spinae nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Paravertebral Nerve Block', 'description': 'Paravertebral nerve block\n\nParavertebral nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 4, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Respiratory Depression', 'notes': 'Respiratory Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation', 'notes': 'Patient went into atrial fibrillation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Redo Nerve Block', 'notes': "The patient's nerve block had to be redone.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erector Spinae Nerve Block', 'description': 'Erector Spinae nerve block\n\nErector Spinae nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.'}, {'id': 'OG001', 'title': 'Paravertebral Nerve Block', 'description': 'Paravertebral nerve block\n\nParavertebral nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.'}], 'classes': [{'categories': [{'measurements': [{'value': '187.36', 'spread': '184.35', 'groupId': 'OG000'}, {'value': '164.70', 'spread': '142.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day post catheter removal', 'description': 'Morphine equivalents (total OME)', 'unitOfMeasure': 'mg morphine equivalent (MME)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Patient Reported Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erector Spinae Nerve Block', 'description': 'Erector Spinae nerve block\n\nErector Spinae nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.'}, {'id': 'OG001', 'title': 'Paravertebral Nerve Block', 'description': 'Paravertebral nerve block\n\nParavertebral nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.98', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '5.16', 'spread': '2.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day post catheter removal', 'description': 'Visual analog scale. Scale is from 0 to 10 numerical pain rating scale. 0 indicates no pain. 10 indicates maximum level of pain. Higher scores indicate worse pain level. Pain score will be a single number from 0 to 10.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Amount Achieved on Incentive Spirometer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erector Spinae Nerve Block', 'description': 'Erector Spinae nerve block\n\nErector Spinae nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.'}, {'id': 'OG001', 'title': 'Paravertebral Nerve Block', 'description': 'Paravertebral nerve block\n\nParavertebral nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.'}], 'classes': [{'categories': [{'measurements': [{'value': '1221.15', 'spread': '480.77', 'groupId': 'OG000'}, {'value': '1187.50', 'spread': '541.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day post catheter removal', 'description': 'Amount achieved on incentive spirometer device (mL). Higher level indicates better respiratory effort', 'unitOfMeasure': 'milliliter (mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erector Spinae Nerve Block', 'description': 'Erector Spinae nerve block\n\nErector Spinae nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.'}, {'id': 'OG001', 'title': 'Paravertebral Nerve Block', 'description': 'Paravertebral nerve block\n\nParavertebral nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.'}], 'classes': [{'categories': [{'measurements': [{'value': '101.96', 'spread': '49.99', 'groupId': 'OG000'}, {'value': '96.30', 'spread': '41.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 weeks on average', 'description': 'Length of hospital stay post-surgery', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Catheter Remains Inserted in Body', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erector Spinae Nerve Block', 'description': 'Erector Spinae nerve block\n\nErector Spinae nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.'}, {'id': 'OG001', 'title': 'Paravertebral Nerve Block', 'description': 'Paravertebral nerve block\n\nParavertebral nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.99', 'spread': '12.96', 'groupId': 'OG000'}, {'value': '21.94', 'spread': '11.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 days', 'description': 'How long catheter remains providing pain relief', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Averaged Total of Narcotic Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erector Spinae Nerve Block', 'description': 'Erector Spinae nerve block\n\nErector Spinae nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.'}, {'id': 'OG001', 'title': 'Paravertebral Nerve Block', 'description': 'Paravertebral nerve block\n\nParavertebral nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.'}], 'classes': [{'categories': [{'measurements': [{'value': '187.36', 'spread': '190.82', 'groupId': 'OG000'}, {'value': '164.7', 'spread': '147.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-120 hours post-operative', 'description': 'Averaged total Narcotic consumption measured in Oral Morphine Equivalence (OME)', 'unitOfMeasure': 'Average of OME', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Report of Adverse Events From Catheter Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erector Spinae Nerve Block', 'description': 'Erector Spinae nerve block\n\nErector Spinae nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.'}, {'id': 'OG001', 'title': 'Paravertebral Nerve Block', 'description': 'Paravertebral nerve block\n\nParavertebral nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day post catheter removal', 'description': 'Participant count for patients who experienced adverse events with nerve block catheter placement which includes pneumothorax, infections, bleeding, local anesthetic toxicity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Erector Spinae Nerve Block', 'description': 'Erector Spinae nerve block\n\nErector Spinae nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.'}, {'id': 'FG001', 'title': 'Paravertebral Nerve Block', 'description': 'Paravertebral nerve block\n\nParavertebral nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Erector Spinae Nerve Block', 'description': 'Erector Spinae nerve block\n\nErector Spinae nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.'}, {'id': 'BG001', 'title': 'Paravertebral Nerve Block', 'description': 'Paravertebral nerve block\n\nParavertebral nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.'}, {'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': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.47', 'spread': '13.51', 'groupId': 'BG000'}, {'value': '65.94', 'spread': '12.22', 'groupId': 'BG001'}, {'value': '65.18', 'spread': '12.92', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '79.98', 'spread': '23.04', 'groupId': 'BG000'}, {'value': '80.17', 'spread': '17.79', 'groupId': 'BG001'}, {'value': '80.07', 'spread': '20.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height (cm)', 'classes': [{'categories': [{'measurements': [{'value': '167.35', 'spread': '9.90', 'groupId': 'BG000'}, {'value': '165.21', 'spread': '8.69', 'groupId': 'BG001'}, {'value': '166.31', 'spread': '9.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeter (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '28.54', 'spread': '8.33', 'groupId': 'BG000'}, {'value': '29.49', 'spread': '5.96', 'groupId': 'BG001'}, {'value': '29.00', 'spread': '7.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-28', 'size': 136125, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_003.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-06-13T09:57', 'hasProtocol': True}, {'date': '2020-01-03', 'size': 132310, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_004.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-06-13T09:57', 'hasProtocol': False}, {'date': '2020-01-03', 'size': 321861, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-04-28T11:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 groups of patients will be studied simultaneously. One group will have the intervention of the nerve block in the erector spinae approach and the other group will have the nerve block in the traditional paravertebral approach.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-13', 'studyFirstSubmitDate': '2018-11-27', 'resultsFirstSubmitDate': '2023-04-28', 'studyFirstSubmitQcDate': '2018-11-27', 'lastUpdatePostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-13', 'studyFirstPostDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Opioid Consumption', 'timeFrame': '1 day post catheter removal', 'description': 'Morphine equivalents (total OME)'}, {'measure': 'Patient Reported Pain Scores', 'timeFrame': '1 day post catheter removal', 'description': 'Visual analog scale. Scale is from 0 to 10 numerical pain rating scale. 0 indicates no pain. 10 indicates maximum level of pain. Higher scores indicate worse pain level. Pain score will be a single number from 0 to 10.'}], 'secondaryOutcomes': [{'measure': 'Amount Achieved on Incentive Spirometer', 'timeFrame': '1 day post catheter removal', 'description': 'Amount achieved on incentive spirometer device (mL). Higher level indicates better respiratory effort'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Up to 2 weeks on average', 'description': 'Length of hospital stay post-surgery'}, {'measure': 'Time Catheter Remains Inserted in Body', 'timeFrame': '6 days', 'description': 'How long catheter remains providing pain relief'}, {'measure': 'Averaged Total of Narcotic Usage', 'timeFrame': '0-120 hours post-operative', 'description': 'Averaged total Narcotic consumption measured in Oral Morphine Equivalence (OME)'}, {'measure': 'Report of Adverse Events From Catheter Placement', 'timeFrame': '1 day post catheter removal', 'description': 'Participant count for patients who experienced adverse events with nerve block catheter placement which includes pneumothorax, infections, bleeding, local anesthetic toxicity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VATS', 'Regional Anesthesia', 'Paravertebral nerve block', 'Erector Spinae nerve block', 'Video assisted thoracoscopic surgery'], 'conditions': ['Thoracic Surgical Procedures']}, 'referencesModule': {'references': [{'pmid': '29169795', 'type': 'BACKGROUND', 'citation': "D'Ercole F, Arora H, Kumar PA. Paravertebral Block for Thoracic Surgery. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):915-927. doi: 10.1053/j.jvca.2017.10.003. Epub 2017 Oct 4."}, {'pmid': '26897642', 'type': 'BACKGROUND', 'citation': 'Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.'}, {'pmid': '30292068', 'type': 'BACKGROUND', 'citation': 'Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.'}, {'pmid': '28203765', 'type': 'BACKGROUND', 'citation': 'Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013. No abstract available.'}, {'pmid': '28372654', 'type': 'BACKGROUND', 'citation': 'Ueshima H, Otake H. RETRACTED: Clinical experiences of ultrasound-guided erector spinae plane block for thoracic vertebra surgery. J Clin Anesth. 2017 May;38:137. doi: 10.1016/j.jclinane.2016.12.028. Epub 2017 Feb 17. No abstract available.', 'retractions': [{'pmid': '35396111', 'source': 'J Clin Anesth. 2022 Aug;79:110791'}]}, {'pmid': '29336785', 'type': 'BACKGROUND', 'citation': 'Luis-Navarro JC, Seda-Guzman M, Luis-Moreno C, Lopez-Romero JL. The erector spinae plane block in 4 cases of video-assisted thoracic surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Apr;65(4):204-208. doi: 10.1016/j.redar.2017.12.004. Epub 2018 Jan 11. English, Spanish.'}]}, 'descriptionModule': {'briefSummary': 'Continuous paravertebral analgesia and erector spinae plane blockade (ESP) are accepted techniques at University of Pittsburgh Medical Center (UPMC) for the management of thoracic pain following surgery and trauma. Recently, an increasing number of erector spinae plane nerve blocks are being performed as it has been demonstrated in our institution, and via case reports that the blocks provide clinical effectiveness, but may have a better side-effect profile than the paravertebral nerve block. However, the relative efficacy of ESP compared to paravertebral nerve block remains to be established for video assisted thoracoscopic surgery (VATS). This is a prospective randomized study intended to assess the efficacy, safety and side-effect profile of continuous erector spinae plane analgesia versus continuous paravertebral analgesia for VATS procedures. It will include 60 patients presenting to UPMC Passavant for a VATS procedure. Patients will be randomized 1:1 to receive either a nerve block via continuous paravertebral infusion or via erector spinae plane infusion. In addition, to treat breakthrough pain, the patients in both arms will receive multimodal adjunctive therapy per routine. Bupivacaine and ropivacaine are FDA approved for use in nerve block catheters. The primary outcome will be to compare analgesic efficacy between the two nerve blocks as defined by total opioid consumption and pain scores on the numeric pain rating scale. Secondary outcomes include incentive spirometer amounts (baseline vs daily score postoperatively), length of stay, duration of catheter and report of adverse events or complications. Other data points include number of chest tubes and location and level of catheter and nerve block placement as well as number of blocks per case.', 'detailedDescription': 'Background and significance:\n\nMultimodal analgesia for thoracic surgery is key to allow faster recovery and diminish postoperative complications. Paravertebral nerve blocks as well as epidurals are among the regional anesthetic techniques utilized for these procedures. Recently, a newer technique, the erector spinae plane block, has been used and described to be effective in treating pain for patients undergoing thoracic surgery. At UPMC, the investigators have had clinically significant pain control for thoracic surgery with both types of blocks. The previous case reports/series and our clinical observation has led us to propose this study of comparing the clinical efficacy of erector spinae plane block vs. paravertebral nerve block.\n\nThough ESP and paravertebral blocks have been documented to be efficacious for this procedure, there has been no direct comparison between the two approaches. The ESP block is considered to be a safer technique with less theoretical adverse events possible and thus, would become a viable alternative to the more technically challenging paravertebral nerve block. If ESP is found to be superior or non-inferior to paravertebral in terms of pain management and safety, this would be a major finding, as ESP is considered safer and technically easier to perform than paravertebral nerve block.\n\nStudy design and methods\n\nThe investigators present a prospective randomized trial comparing the efficacy of continuous paravertebral nerve blocks vs. ESP blocks for video assisted thoracoscopy surgery (VATS) at UPMC Passavant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients undergoing VATS agreeable to have a nerve block as analgesic technique\n* Age: 18 years old and older.\n* ASA (American Society of Anesthesiologists Class) I-IV\n\nExclusion criteria:\n\n* Cognitive impairment that would not allow effective nerve block placement or gathering information related to the study (ex. pain score).\n* Contraindications for nerve block placement such as coagulopathy, use of clopidogrel in the past 48hs, patients on dual antiplatelet therapy, infection at the site of puncture, patient refusal, allergy to local anesthetics.\n* Chronic opiate consumption\n* Patient expected to be on therapeutic anticoagulation post procedure.\n* Pregnancy\n* Comorbid conditions: Any comorbid condition that in the judgment of the anesthesiologist would preclude the patient from any aspect of the study (ex. sepsis, possibly abnormalities of the thoracic spine or paravertebral anatomy such as neoplastic mass occupying the space, empyema, increased intracranial pressure)'}, 'identificationModule': {'nctId': 'NCT03758261', 'briefTitle': 'Erector Spinae Plane vs. Paravertebral Nerve Block for Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Randomized Clinical Trial of Erector Spinae Plane (ESP) Versus Paravertebral Nerve (PVB) Blockade for Video Assisted Thoracoscopic Surgery (VATS)', 'orgStudyIdInfo': {'id': 'PRO18070064'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Erector Spinae Nerve Block', 'description': 'Erector Spinae nerve block', 'interventionNames': ['Drug: Erector Spinae nerve block']}, {'type': 'OTHER', 'label': 'Paravertebral Nerve Block', 'description': 'Paravertebral nerve block', 'interventionNames': ['Drug: Paravertebral nerve block']}], 'interventions': [{'name': 'Paravertebral nerve block', 'type': 'DRUG', 'description': 'The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.', 'armGroupLabels': ['Paravertebral Nerve Block']}, {'name': 'Erector Spinae nerve block', 'type': 'DRUG', 'description': 'The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.', 'armGroupLabels': ['Erector Spinae Nerve Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15237', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Passavant', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Charles Luke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles Luke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Charles Luke', 'investigatorAffiliation': 'University of Pittsburgh'}}}}