Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-02-03 @ 3:26 AM
Study NCT ID:
NCT03151434
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2017-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Three Different Pain Blocks for Subjects Undergoing VATS (Video Assisted Thoracoscopic Surgery) Procedure.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013662', 'term': 'Tea'}, {'id': 'D004091', 'term': 'Hydromorphone'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yyeap@iupui.edu', 'phone': '3172740275', 'title': 'Dr. Yar Luan Yeap', 'organization': 'Indiana University Department of Anesthesiology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Participants were followed for 6 months after surgery. Any adverse event from surgery day till 6 months after surgery are documented.', 'eventGroups': [{'id': 'EG000', 'title': 'US Guided Single Shot Paravertebral Block', 'description': 'group 1- US Guided Single Shot Paravertebral Block\n\nUS Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'US Guided Paravertebral Catheter', 'description': 'group 2- US Guided Paravertebral Catheter\n\nUS Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Thoracic Epidural', 'description': 'group 3- Thoracic Epidural\n\nThoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Endpoint of This Study Will be VAS Pain Score at 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'US Guided Single Shot Paravertebral Block', 'description': 'group 1- US Guided Single Shot Paravertebral Block\n\nUS Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.'}, {'id': 'OG001', 'title': 'US Guided Paravertebral Catheter', 'description': 'group 2- US Guided Paravertebral Catheter\n\nUS Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.'}, {'id': 'OG002', 'title': 'Thoracic Epidural', 'description': 'group 3- Thoracic Epidural\n\nThoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '5.5'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '6.0'}, {'value': '3.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pain scores will be measured 24 hours after surgery.', 'description': 'The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using "units on a scale" of 1-10 for documentation with 10 being the worst pain and 0 being no pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Primary Endpoint of This Study Will be VAS Pain Score at 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'US Guided Single Shot Paravertebral Block', 'description': 'group 1- US Guided Single Shot Paravertebral Block\n\nUS Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.'}, {'id': 'OG001', 'title': 'US Guided Paravertebral Catheter', 'description': 'group 2- US Guided Paravertebral Catheter\n\nUS Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.'}, {'id': 'OG002', 'title': 'Thoracic Epidural', 'description': 'group 3- Thoracic Epidural\n\nThoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '5.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pain scores will be measured 48 hours after surgery.', 'description': 'The VAS scores will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using"units on a scale" scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Secondary Endpoint Includes Total Intravenous Opioid Consumption at 72 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group #1', 'description': 'US Guided Single Shot Paravertebral Block\n\nUS Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.'}, {'id': 'OG001', 'title': 'Group #2', 'description': 'US Guided Paravertebral Catheter\n\nUS Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.'}, {'id': 'OG002', 'title': 'Group #3', 'description': 'Thoracic Epidural\n\nThoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '96'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '89'}, {'value': '21.3', 'groupId': 'OG002', 'lowerLimit': '7.5', 'upperLimit': '45'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Opioid consumption will be measured at 1 hour post op, 24,48, and 72 hours post op. The total amount will be recorded.', 'description': 'Opioid consumption will be collected by a study team member post operatively up to 3 days per protocol time requirements', 'unitOfMeasure': 'miligram morphine equivalent', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Average Nausea Scores Over 72 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group #1', 'description': 'US Guided Single Shot Paravertebral Block\n\nUS Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.'}, {'id': 'OG001', 'title': 'Group #2', 'description': 'US Guided Paravertebral Catheter\n\nUS Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.'}, {'id': 'OG002', 'title': 'Group #3', 'description': 'Thoracic Epidural\n\nThoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0.27', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0.29', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the surgery.The scores will then be averaged.', 'description': 'Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as 0=none, 1=mild, 2=moderate, or 3=severe', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Average Sedation Scores Over 72 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group #1', 'description': 'US Guided Single Shot Paravertebral Block\n\nUS Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.'}, {'id': 'OG001', 'title': 'Group #2', 'description': 'US Guided Paravertebral Catheter\n\nUS Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.'}, {'id': 'OG002', 'title': 'Group #3', 'description': 'Thoracic Epidural\n\nThoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.38', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0.32', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0.22', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the sugery. The scores will then be averaged.', 'description': 'Sedation scores will be documented by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is 0=awake and alert, 1=quietly awake, 2=asleep and arousable, or 3=deep sleep.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subjects Overall Satisfaction Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group #1', 'description': 'US Guided Single Shot Paravertebral Block\n\nUS Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.'}, {'id': 'OG001', 'title': 'Group #2', 'description': 'US Guided Paravertebral Catheter\n\nUS Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.'}, {'id': 'OG002', 'title': 'Group #3', 'description': 'Thoracic Epidural\n\nThoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0.95', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1.33', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post operatively at hour 24', 'description': 'Subjects will be followed up at 24 hours post operatively by a study team member to document patient overall satisfaction scores. Score was recorded as 0=dissatisfied, 1=satisfied, 2=very satisfied.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subjects Overall Satisfaction Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group #1', 'description': 'US Guided Single Shot Paravertebral Block\n\nUS Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.'}, {'id': 'OG001', 'title': 'Group #2', 'description': 'US Guided Paravertebral Catheter\n\nUS Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.'}, {'id': 'OG002', 'title': 'Group #3', 'description': 'Thoracic Epidural\n\nThoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.19', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1.05', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1.32', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post operatively at hour 48', 'description': 'Subjects will be followed up at 48 hours post operatively by a study team member to document patient overall satisfaction scores. Scores will be recorded as 0=dissatisfied, 1=satisfied, 2=very satisfied.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group #1', 'description': 'US Guided Single Shot Paravertebral Block\n\nUS Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.'}, {'id': 'FG001', 'title': 'Group #2', 'description': 'US Guided Paravertebral Catheter\n\nUS Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.'}, {'id': 'FG002', 'title': 'Group #3', 'description': 'Thoracic Epidural\n\nThoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'US Guided Single Shot Paravertebral Block', 'description': 'group 1- US Guided Single Shot Paravertebral Block\n\nUS Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.'}, {'id': 'BG001', 'title': 'US Guided Paravertebral Catheter', 'description': 'group 2- US Guided Paravertebral Catheter\n\nUS Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.'}, {'id': 'BG002', 'title': 'Thoracic Epidural', 'description': 'group 3- Thoracic Epidural\n\nThoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.5', 'groupId': 'BG000', 'lowerLimit': '48.5', 'upperLimit': '70'}, {'value': '62', 'groupId': 'BG001', 'lowerLimit': '45.5', 'upperLimit': '69.5'}, {'value': '61', 'groupId': 'BG002', 'lowerLimit': '52', 'upperLimit': '70'}, {'value': '62', 'groupId': 'BG003', 'lowerLimit': '48', 'upperLimit': '70'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'height', 'classes': [{'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000', 'lowerLimit': '162', 'upperLimit': '177.8'}, {'value': '167.6', 'groupId': 'BG001', 'lowerLimit': '165', 'upperLimit': '173.9'}, {'value': '173.5', 'groupId': 'BG002', 'lowerLimit': '161.3', 'upperLimit': '179.3'}, {'value': '170', 'groupId': 'BG003', 'lowerLimit': '162', 'upperLimit': '177.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Centimeter', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'weight', 'classes': [{'categories': [{'measurements': [{'value': '88.4', 'groupId': 'BG000', 'lowerLimit': '72.2', 'upperLimit': '105'}, {'value': '77.7', 'groupId': 'BG001', 'lowerLimit': '67', 'upperLimit': '90.4'}, {'value': '87.3', 'groupId': 'BG002', 'lowerLimit': '65.8', 'upperLimit': '106.7'}, {'value': '84.1', 'groupId': 'BG003', 'lowerLimit': '67.1', 'upperLimit': '102.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Kilogram', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-15', 'size': 522621, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-06T14:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients randomized to epidural, single shot paravertebral block, and paravertebral catheter'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-07', 'studyFirstSubmitDate': '2017-03-22', 'resultsFirstSubmitDate': '2020-09-18', 'studyFirstSubmitQcDate': '2017-05-10', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-07', 'studyFirstPostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Average Nausea Scores Over 72 Hours', 'timeFrame': 'Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the surgery.The scores will then be averaged.', 'description': 'Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as 0=none, 1=mild, 2=moderate, or 3=severe'}, {'measure': 'Average Sedation Scores Over 72 Hours', 'timeFrame': 'Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the sugery. The scores will then be averaged.', 'description': 'Sedation scores will be documented by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is 0=awake and alert, 1=quietly awake, 2=asleep and arousable, or 3=deep sleep.'}, {'measure': 'Subjects Overall Satisfaction Scores', 'timeFrame': 'post operatively at hour 24', 'description': 'Subjects will be followed up at 24 hours post operatively by a study team member to document patient overall satisfaction scores. Score was recorded as 0=dissatisfied, 1=satisfied, 2=very satisfied.'}, {'measure': 'Subjects Overall Satisfaction Scores', 'timeFrame': 'post operatively at hour 48', 'description': 'Subjects will be followed up at 48 hours post operatively by a study team member to document patient overall satisfaction scores. Scores will be recorded as 0=dissatisfied, 1=satisfied, 2=very satisfied.'}], 'primaryOutcomes': [{'measure': 'The Primary Endpoint of This Study Will be VAS Pain Score at 24 Hours', 'timeFrame': 'Pain scores will be measured 24 hours after surgery.', 'description': 'The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using "units on a scale" of 1-10 for documentation with 10 being the worst pain and 0 being no pain'}, {'measure': 'The Primary Endpoint of This Study Will be VAS Pain Score at 48 Hours', 'timeFrame': 'Pain scores will be measured 48 hours after surgery.', 'description': 'The VAS scores will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using"units on a scale" scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain'}], 'secondaryOutcomes': [{'measure': 'Secondary Endpoint Includes Total Intravenous Opioid Consumption at 72 Hours', 'timeFrame': 'Opioid consumption will be measured at 1 hour post op, 24,48, and 72 hours post op. The total amount will be recorded.', 'description': 'Opioid consumption will be collected by a study team member post operatively up to 3 days per protocol time requirements'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VATS', 'pain'], 'conditions': ['Video Assisted Thoracoscopic Surgery', 'Pain, Postoperative', 'Pain, Acute']}, 'referencesModule': {'references': [{'pmid': '24336691', 'type': 'BACKGROUND', 'citation': 'Bottiger BA, Esper SA, Stafford-Smith M. Pain management strategies for thoracotomy and thoracic pain syndromes. Semin Cardiothorac Vasc Anesth. 2014 Mar;18(1):45-56. doi: 10.1177/1089253213514484. Epub 2013 Dec 12.'}, {'pmid': '19237975', 'type': 'BACKGROUND', 'citation': 'Daly DJ, Myles PS. Update on the role of paravertebral blocks for thoracic surgery: are they worth it? Curr Opin Anaesthesiol. 2009 Feb;22(1):38-43. doi: 10.1097/ACO.0b013e32831a4074.'}, {'pmid': '23151421', 'type': 'BACKGROUND', 'citation': 'Dango S, Harris S, Offner K, Hennings E, Priebe HJ, Buerkle H, Passlick B, Loop T. Combined paravertebral and intrathecal vs thoracic epidural analgesia for post-thoracotomy pain relief. Br J Anaesth. 2013 Mar;110(3):443-9. doi: 10.1093/bja/aes394. Epub 2012 Nov 14.'}, {'pmid': '16476698', 'type': 'BACKGROUND', 'citation': 'Davies RG, Myles PS, Graham JM. A comparison of the analgesic efficacy and side-effects of paravertebral vs epidural blockade for thoracotomy--a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2006 Apr;96(4):418-26. doi: 10.1093/bja/ael020. Epub 2006 Feb 13.'}, {'type': 'BACKGROUND', 'citation': 'El-Morsy, W. Z. (2013). Thoracic epidural analgesia versus parenteral morphine for post-thoracotomy pain relief. Ain-Shams Journal of Anaesthesiology, 6(2), 180.'}, {'pmid': '22914044', 'type': 'BACKGROUND', 'citation': 'Fortier S, Hanna HA, Bernard A, Girard C. Comparison between systemic analgesia, continuous wound catheter analgesia and continuous thoracic paravertebral block: a randomised, controlled trial of postthoracotomy pain management. Eur J Anaesthesiol. 2012 Nov;29(11):524-30. doi: 10.1097/EJA.0b013e328357e5a1.'}, {'pmid': '21316259', 'type': 'BACKGROUND', 'citation': 'Fibla JJ, Molins L, Mier JM, Sierra A, Carranza D, Vidal G. The efficacy of paravertebral block using a catheter technique for postoperative analgesia in thoracoscopic surgery: a randomized trial. Eur J Cardiothorac Surg. 2011 Oct;40(4):907-11. doi: 10.1016/j.ejcts.2010.12.043. Epub 2011 Feb 11.'}, {'pmid': '21377888', 'type': 'BACKGROUND', 'citation': 'Helms O, Mariano J, Hentz JG, Santelmo N, Falcoz PE, Massard G, Steib A. Intra-operative paravertebral block for postoperative analgesia in thoracotomy patients: a randomized, double-blind, placebo-controlled study. Eur J Cardiothorac Surg. 2011 Oct;40(4):902-6. doi: 10.1016/j.ejcts.2011.01.067. Epub 2011 Mar 5.'}, {'pmid': '22055006', 'type': 'BACKGROUND', 'citation': 'Kaya FN, Turker G, Mogol EB, Bayraktar S. Thoracic paravertebral block for video-assisted thoracoscopic surgery: single injection versus multiple injections. J Cardiothorac Vasc Anesth. 2012 Feb;26(1):90-4. doi: 10.1053/j.jvca.2011.09.008. Epub 2011 Nov 4.'}, {'pmid': '23445804', 'type': 'BACKGROUND', 'citation': 'Komatsu T, Sowa T, Takahashi K, Fujinaga T. Paravertebral block as a promising analgesic modality for managing post-thoracotomy pain. Ann Thorac Cardiovasc Surg. 2014;20(2):113-6. doi: 10.5761/atcs.oa.12.01999. Epub 2013 Feb 28.'}, {'type': 'BACKGROUND', 'citation': 'Mackay, J. H., & Gray, S. J. (2013). Principles and Practice of Anesthesia for Thoracic Surgery. British Journal of Anaesthesia, 110(5), 857-858.'}, {'pmid': '10655907', 'type': 'BACKGROUND', 'citation': 'Richardson J, Sabanathan S, Jones J, Shah RD, Cheema S, Mearns AJ. A prospective, randomized comparison of preoperative and continuous balanced epidural or paravertebral bupivacaine on post-thoracotomy pain, pulmonary function and stress responses. Br J Anaesth. 1999 Sep;83(3):387-92. doi: 10.1093/bja/83.3.387.'}, {'pmid': '23130723', 'type': 'BACKGROUND', 'citation': 'Shelley B, Macfie A. Where now for thoracic paravertebral blockade? Anaesthesia. 2012 Dec;67(12):1317-20. doi: 10.1111/j.1365-2044.2012.07310.x. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'Slater, B., & Frost, E. A. (2012). Pain Management After Thoracic Surgery.Topics in Pain Management, 28(3), 1-8.'}, {'pmid': '24447266', 'type': 'BACKGROUND', 'citation': 'Yoshida T, Fujiwara T, Furutani K, Ohashi N, Baba H. Effects of ropivacaine concentration on the spread of sensory block produced by continuous thoracic paravertebral block: a prospective, randomised, controlled, double-blind study. Anaesthesia. 2014 Mar;69(3):231-9. doi: 10.1111/anae.12531. Epub 2014 Jan 21.'}, {'pmid': '17095972', 'type': 'BACKGROUND', 'citation': 'Yoshioka M, Mori T, Kobayashi H, Iwatani K, Yoshimoto K, Terasaki H, Nomori H. The efficacy of epidural analgesia after video-assisted thoracoscopic surgery: a randomized control study. Ann Thorac Cardiovasc Surg. 2006 Oct;12(5):313-8.'}, {'pmid': '32144059', 'type': 'RESULT', 'citation': 'Yeap YL, Wolfe JW, Backfish-White KM, Young JV, Stewart J, Ceppa DP, Moser EAS, Birdas TJ. Randomized Prospective Study Evaluating Single-Injection Paravertebral Block, Paravertebral Catheter, and Thoracic Epidural Catheter for Postoperative Regional Analgesia After Video-Assisted Thoracoscopic Surgery. J Cardiothorac Vasc Anesth. 2020 Jul;34(7):1870-1876. doi: 10.1053/j.jvca.2020.01.036. Epub 2020 Jan 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare three different pain control methods on subjects who are scheduled to undergo VATS (video-assisted thoracoscopic surgery) procedures. The study will compare their pain scores, narcotic needs, patient satisfaction scores, and narcotic side effects.', 'detailedDescription': "All patients will be consented on the morning of surgery. All the thoracic epidurals and ultrasound-guided paravertebral blocks will be placed preoperatively. The procedures will be done using sterile technique with masks, hats, and sterile gloves. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nThoracic epidurals will be placed using the Arrow thoracic epidural kit. The epidural will be placed at the appropriate level to cover the entry site for the VATS procedure. Placement will be determined by anatomical landmarks. The epidural needle will be advanced toward the epidural space utilizing a Paramedian approach and loss-of-resistance technique. A sterile catheter will then be secured in place and the epidural infusion will be started at the end of the case.\n\nUltrasound guided paravertebral catheter and single shot paravertebral block will be accomplished using an ultrasound transducer at the thoracic level. This will be done using an in-plane or out-of-plane approach, at the discretion of the anesthesia staff performing the procedure. Then a needle will be inserted the needle into the paravertebral space and local anesthetic injected. Then a catheter will be placed within the injectate and secured in place in the case of the paravertebral catheter. The 0.2% Ropivicaine will be delivered by OnQ pump.\n\nGeneral anesthesia will be induced and the patient will be placed in the lateral position for the VATS procedure. The patients will be intubated with dual lumen endotracheal tubes and placed on one-lung ventilation for the procedure.\n\nAll patients will receive intravenous patient-controlled analgesia (PCA hydromorphone) post-operatively for breakthrough pain. They will also be scheduled on PO acetaminophen. PO oxycodone PRN will be started on POD 1 once patients tolerate diet.\n\nOpioid usage at 1,24,48,72 hours after the block will be recorded by a member of the research team. Pain scores at rest and on movement (knee flexion) will be measured by the investigator using Visual Analog Scale (VAS). Nausea will be measured using a categorical scoring system (none=0; mild=1; moderate=2; severe=3). Sedation scores will also be assessed by a member of the study team using a sedation scale (awake and alert=0; quietly awake=1; asleep but easily roused=2; deep sleep=3). All these parameters will be measured at 1, 24, 48 and 72 hours after the epidural or PVB. Patients will be encouraged to ambulate on postoperative day 1 under supervision.\n\nAll catheters will be removed by APS (Acute Pain Service) while patients are still in the hospital. APS will continue to follow the patients until catheter removal. Patient's hospital length of stay and readmission rate will be recorded from NSQIP (National Surgical Quality Improvement Program) data.\n\nAll patients will receive a phone call 6 months after surgery for assessment for chronic post-surgical pain. Patients will be assessed by a member of the research team over the phone. They will be assessed on their pain score and narcotic usage by using the Brief Pain Inventory. Study participation will conclude after the 6 month follow questionnaire has been completed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pt undergoing VATS procedure at Indiana University Hospital\n* ASA 1,2,3 or 4\n* Age 18 or older, male or female\n* Desires Regional anesthesia for postoperative pain control\n\nExclusion Criteria:\n\n* Any contraindication for Thoracic Epidural or Paravertebral block\n* History of substance abuse in the past 6 months\n* Patient staying intubated after surgery\n* Known allergy or other contraindications to the study medications , which include dilaudid, bupivacaine, ropivacaine'}, 'identificationModule': {'nctId': 'NCT03151434', 'acronym': 'VATS', 'briefTitle': 'Comparison of Three Different Pain Blocks for Subjects Undergoing VATS (Video Assisted Thoracoscopic Surgery) Procedure.', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Randomized Prospective Study Comparing Paravertebral Catheters, Single Shot Paravertebral Block, Thoracic Epidural, for Postoperative Analgesia Following Video-assisted Thoracoscopic Surgery', 'orgStudyIdInfo': {'id': '1601583558'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group #1', 'description': 'US Guided Single Shot Paravertebral Block', 'interventionNames': ['Drug: US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group #2', 'description': 'US Guided Paravertebral Catheter', 'interventionNames': ['Drug: US Guided Paravertebral Catheter (0.2% ropivicaine bolus)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group #3', 'description': 'Thoracic Epidural', 'interventionNames': ['Drug: Thoracic Epidural (0.125% bupivicaine/hydromorphone)']}], 'interventions': [{'name': 'US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion)', 'type': 'DRUG', 'otherNames': ['US Guided Single Shot Paravertebral Block'], 'description': 'Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.', 'armGroupLabels': ['Group #1']}, {'name': 'US Guided Paravertebral Catheter (0.2% ropivicaine bolus)', 'type': 'DRUG', 'otherNames': ['US Guided Paravertebral Catheter'], 'description': 'Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.', 'armGroupLabels': ['Group #2']}, {'name': 'Thoracic Epidural (0.125% bupivicaine/hydromorphone)', 'type': 'DRUG', 'description': 'Epidural catheter will be placed in the thoracic region prior to surgery.', 'armGroupLabels': ['Group #3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Yar Yeap, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Acute Pain Service Assistant Professor of Clinical Anesthesiology Indiana University School of Medicine Department of Anesthesiology', 'investigatorFullName': 'Yar Yeap', 'investigatorAffiliation': 'Indiana University'}}}}