Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT05664958
Status:
COMPLETED
Last Update Posted:
2025-02-05
First Post:
2022-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ESP Block for Post Cesarean Analgesia
Sponsor:
Organization:
Raw JSON
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OME are approximations of the equianalgesic effects of other opioids compared to oral morphine. Thus, OMEs indicate how much of the reference drug oral morphine would be required to treat pain as effectively as the comparison opioid.', 'unitOfMeasure': 'mg OME', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to First Postsurgical Opioid Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ESP Block', 'description': 'Standard of care analgesic regimen with ESP Block\n\nErector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine\n\nbupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side.\n\nbupivacaine: 20 ml bupivacaine 0.25% per side.'}, {'id': 'OG001', 'title': 'Historical Control', 'description': 'Standard of care analgesic regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '30.2'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '13.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0-48 hours', 'description': 'Time to first rescue opioid medication used for the treatment of breakthrough pain', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve (AUC) of Verbal Rating Scale (VRS) Pain Intensity Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ESP Block', 'description': 'Standard of care analgesic regimen with ESP Block\n\nErector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine\n\nbupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side.\n\nbupivacaine: 20 ml bupivacaine 0.25% per side.'}, {'id': 'OG001', 'title': 'Historical Control', 'description': 'Standard of care analgesic regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '151'}, {'value': '140', 'groupId': 'OG001', 'lowerLimit': '86', 'upperLimit': '180'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0-48 hours', 'description': "Area under the curve (AUC) of verbal rating scale (VRS) pain intensity scores, lower scores indicate a better outcome. The VRS consists of a scale of 0 ('no pain') to 10 ('pain as bad as it could possibly be').", 'unitOfMeasure': 'pain score unit*hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Postoperative Nausea and Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ESP Block', 'description': 'Standard of care analgesic regimen with ESP Block\n\nErector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine\n\nbupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side.\n\nbupivacaine: 20 ml bupivacaine 0.25% per side.'}, {'id': 'OG001', 'title': 'Historical Control', 'description': 'Standard of care analgesic regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-48 hours', 'description': 'Occurrence of nausea and vomiting 0-48 h after cesarean delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data about postoperative nausea and vomiting not collected on the control group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Need for Rescue Antiemetics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ESP Block', 'description': 'Standard of care analgesic regimen with ESP Block\n\nErector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine\n\nbupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side.\n\nbupivacaine: 20 ml bupivacaine 0.25% per side.'}, {'id': 'OG001', 'title': 'Historical Control', 'description': 'Standard of care analgesic regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-48 hours', 'description': 'Number of participants who needed medications to treat nausea and vomiting', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pruritus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ESP Block', 'description': 'Standard of care analgesic regimen with ESP Block\n\nErector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine\n\nbupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side.\n\nbupivacaine: 20 ml bupivacaine 0.25% per side.'}, {'id': 'OG001', 'title': 'Historical Control', 'description': 'Standard of care analgesic regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-48 hours', 'description': 'Number of participants who complained of pruritus', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data about pruritus not collected on the control group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Need for Rescue Antipruritics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ESP Block', 'description': 'Standard of care analgesic regimen with ESP Block\n\nErector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine\n\nbupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side.\n\nbupivacaine: 20 ml bupivacaine 0.25% per side.'}, {'id': 'OG001', 'title': 'Historical Control', 'description': 'Standard of care analgesic regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-48 hours', 'description': 'Number of participants who needed medications for treatment for pruritus', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Not Receiving Any Rescue Opioids Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ESP Block', 'description': 'Standard of care analgesic regimen with ESP Block\n\nErector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine\n\nbupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side.\n\nbupivacaine: 20 ml bupivacaine 0.25% per side.'}, {'id': 'OG001', 'title': 'Historical Control', 'description': 'Standard of care analgesic regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-48 hours', 'description': 'Number of participants who did not need any opioids for break through pain', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ESP Block', 'description': 'Standard of care analgesic regimen with ESP Block\n\nErector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine\n\nbupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side.\n\nbupivacaine: 20 ml bupivacaine 0.25% per side.'}, {'id': 'FG001', 'title': 'Historical Control', 'description': 'Standard of care analgesic regimen'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '120'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '120'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ESP Block', 'description': 'Standard of care analgesic regimen with ESP Block\n\nErector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine\n\nbupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side.\n\nbupivacaine: 20 ml bupivacaine 0.25% per side.'}, {'id': 'BG001', 'title': 'Historical Control', 'description': 'Standard of care analgesic regimen'}, {'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': '30', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000', 'lowerLimit': '29', 'upperLimit': '36'}, {'value': '33', 'groupId': 'BG001', 'lowerLimit': '30', 'upperLimit': '36'}, {'value': '33', 'groupId': 'BG002', 'lowerLimit': '29', 'upperLimit': '36'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}, {'title': 'Male', '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': '4', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-01', 'size': 81705, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-01T16:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2022-12-09', 'resultsFirstSubmitDate': '2024-10-21', 'studyFirstSubmitQcDate': '2022-12-16', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-03', 'studyFirstPostDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Oxycodone Consumption 0- 48 Hours After Cesarean Delivery', 'timeFrame': '0-48 hours after cesarean delivery', 'description': 'Total dose of rescue oxycodone used in mg 0- 48 hours after cesarean delivery'}], 'secondaryOutcomes': [{'measure': 'Postoperative Opioid Consumption at 24 Hours', 'timeFrame': '0-24 hours', 'description': 'Total dose of rescue opioids used in mg oral morphine equivalents (OME) at 24 hours after cesarean delivery. OME are approximations of the equianalgesic effects of other opioids compared to oral morphine. Thus, OMEs indicate how much of the reference drug oral morphine would be required to treat pain as effectively as the comparison opioid.'}, {'measure': 'Time to First Postsurgical Opioid Rescue Medication', 'timeFrame': '0-48 hours', 'description': 'Time to first rescue opioid medication used for the treatment of breakthrough pain'}, {'measure': 'Area Under the Curve (AUC) of Verbal Rating Scale (VRS) Pain Intensity Scores', 'timeFrame': '0-48 hours', 'description': "Area under the curve (AUC) of verbal rating scale (VRS) pain intensity scores, lower scores indicate a better outcome. The VRS consists of a scale of 0 ('no pain') to 10 ('pain as bad as it could possibly be')."}, {'measure': 'Number of Participants With Postoperative Nausea and Vomiting', 'timeFrame': '0-48 hours', 'description': 'Occurrence of nausea and vomiting 0-48 h after cesarean delivery'}, {'measure': 'Number of Participants With the Need for Rescue Antiemetics', 'timeFrame': '0-48 hours', 'description': 'Number of participants who needed medications to treat nausea and vomiting'}, {'measure': 'Number of Participants With Pruritus', 'timeFrame': '0-48 hours', 'description': 'Number of participants who complained of pruritus'}, {'measure': 'Number of Participants With the Need for Rescue Antipruritics', 'timeFrame': '0-48 hours', 'description': 'Number of participants who needed medications for treatment for pruritus'}, {'measure': 'Number of Participants Not Receiving Any Rescue Opioids Postoperatively', 'timeFrame': '0-48 hours', 'description': 'Number of participants who did not need any opioids for break through pain'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section Complications']}, 'referencesModule': {'references': [{'pmid': '39981694', 'type': 'DERIVED', 'citation': 'Feldman S, Holmes RJ Jr, Fuller M, Habib AS. Erector spinae plane block with liposomal bupivacaine for post-cesarean analgesia. Int J Gynaecol Obstet. 2025 Jul;170(1):489-495. doi: 10.1002/ijgo.70027. Epub 2025 Feb 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to assess the analgesic efficacy of Erector Spinae Plane block (ESPB) with liposomal bupivacaine in women undergoing cesarean delivery and receiving a postoperative multimodal analgesic regimen as assessed by the dose of rescue postoperative opioids compared to a historical control group of women receiving the same multimodal regimen but with no truncal blocks. This will be a case control study with a prospective and a retrospective component. Women undergoing elective cesarean delivery under spinal or combined spinal epidural anesthesia will be approached to participate in the prospective open label component of the study. Cases will be matched in a 1:4 ratio by age, race, history of prior cesarean delivery, and insurance status with historical controls who received the same multimodal analgesic regimen but no truncal blocks. We plan to enroll 30 subjects for the prospective arm of the study and 120 for the retrospective arm.', 'detailedDescription': 'This will be a case control study with a prospective and a retrospective component. Women undergoing elective cesarean delivery under spinal or combined spinal epidural anesthesia will be approached to participate in the prospective open label component of the study. Those women will receive the standard of care intraoperative and postoperative analgesic regimen used at Duke university incorporating 100 mcg intrathecal morphine, intraoperative acetaminophen 975 mg PR and ketorolac 15 mg IV and postoperative scheduled oral acetaminophen 975 mg every 6 hours, scheduled 15 mg IV ketorolac for 3 doses every 6 hours followed by oral ibuprofen 600 mg every 6 hours. At the end of surgery, a bilateral ESPB will be performed under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side.\n\nCases will be matched in a 1:4 ratio by age, race, history of prior cesarean delivery, and insurance status with historical controls who received the same multimodal analgesic regimen but no truncal blocks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients ≥18 years of age with a term pregnancy of 37 to 42 weeks and American Society of Anesthesiologists Physical Status Classification II or III scheduled to undergo elective CD.\n\nExclusion Criteria:\n\n* ≥3 prior CDs, pre-pregnancy body mass index \\>40 kg/m2, planned concurrent surgical procedure other than tubal ligation, chronic pain or chronic opioid therapy, any clinically significant event or condition uncovered during surgery (eg, excessive bleeding, acute sepsis) that might render the patient medically unstable or complicate the patient's postsurgical course, or allergy or contraindication to any component of the multimodal analgesic regimen."}, 'identificationModule': {'nctId': 'NCT05664958', 'briefTitle': 'ESP Block for Post Cesarean Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Erector Spinae Plane Block With Liposomal Bupivacaine for Post Cesarean Delivery Analgesia: A Pilot Study', 'orgStudyIdInfo': {'id': 'Pro00112152'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ESP Block', 'description': 'Standard of care analgesic regimen with ESP Block', 'interventionNames': ['Procedure: Erector Spinae Plane (ESP) Block', 'Drug: bupivacaine liposome injectable suspension', 'Drug: bupivacaine']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard of care analgesic regimen'}], 'interventions': [{'name': 'Erector Spinae Plane (ESP) Block', 'type': 'PROCEDURE', 'description': 'ESP Block with liposomal bupivacaine and immediate release bupivacaine', 'armGroupLabels': ['ESP Block']}, {'name': 'bupivacaine liposome injectable suspension', 'type': 'DRUG', 'description': '133 mg liposomal bupivacaine per side.', 'armGroupLabels': ['ESP Block']}, {'name': 'bupivacaine', 'type': 'DRUG', 'description': '20 ml bupivacaine 0.25% per side.', 'armGroupLabels': ['ESP Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27701', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Ashraf S Habib, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}