Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2026-03-04 @ 9:37 PM
Study NCT ID:
NCT03105518
Status:
UNKNOWN
Last Update Posted:
2022-08-03
First Post:
2014-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D010098', 'term': 'Oxycodone'}, {'id': 'C514822', 'term': 'oxycodone-acetaminophen'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'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': 'ltsen@bwh.harvard.edu', 'phone': '617.732.8216', 'title': 'Lawrence Tsen, MD', 'organization': "Brigham and Women's Hospital/Harvard Medical School"}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'No limitations or caveats noted for this study.'}}, 'adverseEventsModule': {'timeFrame': '3 days', 'eventGroups': [{'id': 'EG000', 'title': 'Analgesia Options', 'description': 'Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.\n\nFentanyl: 0.5, 1 mcg/kg\n\nAcetaminophen: Single + Oxycodone\n\nOxycodone: With Acetaminophen\n\nNo Adverse Events in any subject', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Amount of Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Analgesia Options', 'description': 'Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.\n\nFentanyl: 0.5, 1 mcg/kg\n\nAcetaminophen: Single + Oxycodone\n\nOxycodone: With Acetaminophen'}], 'classes': [{'title': 'Time 0; ≤10 Follicles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.53', 'spread': '2.13', 'groupId': 'OG000'}]}]}, {'title': 'Time 0; > 10 Follicles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.25', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Time 15; ≤10 Follicles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.68', 'spread': '2.19', 'groupId': 'OG000'}]}]}, {'title': 'Time 15; >10 Follicles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.61', 'spread': '1.98', 'groupId': 'OG000'}]}]}, {'title': 'Time 30; ≤10 Follicles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.66', 'spread': '1.40', 'groupId': 'OG000'}]}]}, {'title': 'Time 30; >10 Follicles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.93', 'spread': '1.43', 'groupId': 'OG000'}]}]}, {'title': 'Time 60; ≤10 Follicles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.97', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Time 60; >10 Follicles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.19', 'spread': '1.55', 'groupId': 'OG000'}]}]}, {'title': 'Time POD 3; ≤ 10 Follicles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.44', 'spread': '1.15', 'groupId': 'OG000'}]}]}, {'title': 'Time POD 3; > 10 Follicles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.64', 'spread': '1.82', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000'], 'paramType': '1 way test, chisquare approximation', 'ciNumSides': 'TWO_SIDED', 'paramValue': '7.1880', 'groupDescription': 'VAS at Time 0; Follicles ≤10 vs. \\> 10', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.056', 'groupIds': ['OG000'], 'paramType': '1 way Test, ChiSquare Approximation', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.6396', 'groupDescription': 'VAS at Time 15; Follicles ≤10 vs. \\> 10', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': '1 way Test, ChiSquare Approximation', 'ciNumSides': 'TWO_SIDED', 'paramValue': '15.971', 'groupDescription': 'VAS at Time 30; Follicles ≤10 vs. \\> 10', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': '1-way Test, ChiSquare Approximation', 'ciNumSides': 'TWO_SIDED', 'paramValue': '16.0972', 'groupDescription': 'VAS at Time 60; Follicles ≤10 vs. \\> 10', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'PACU admission, 15, 30 and 60 min postprocedure, postoperative day 3', 'description': 'Change in discomfort following oocyte retrieval with standardized anesthesia management as measured by verbal analogue scoring (0-10 scale). VAS scores correlate to minimal (VAS 0-3), moderate (VAS 4-6) or severe (VAS ≥7) discomfort.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'On PACU admission, subjects were divided into three groups based on the intensity of discomfort. A standardized postoperative analgesic regimen followed, based on VAS score and time (≤ or \\> than 30 min).'}, {'type': 'SECONDARY', 'title': 'Amount of Discomfort Following Discharge Until Embryo Transfer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Analgesia Options', 'description': 'Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.\n\nFentanyl: 0.5, 1 mcg/kg\n\nAcetaminophen: Single + Oxycodone\n\nOxycodone: With Acetaminophen'}], 'classes': [{'title': 'POD1; ≤10 Folli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.15', 'spread': '1.72', 'groupId': 'OG000'}]}]}, {'title': 'POD1; >10 Follicles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.21', 'spread': '1.87', 'groupId': 'OG000'}]}]}, {'title': 'POD2; ≤10 Folli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.28', 'spread': '1.89', 'groupId': 'OG000'}]}]}, {'title': 'POD2; >10 Folli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.50', 'spread': '2.35', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0991', 'groupIds': ['OG000'], 'paramType': '1-way Test, ChiSquare Approximation', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.7205', 'groupDescription': 'VAS at Post Operative Day 1; Follicles ≤10 vs. \\> 10', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2109', 'groupIds': ['OG000'], 'paramType': '1 way Test, ChiSquare Approximation', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.5654', 'groupDescription': 'VAS at Post Operative Day 2; Follicles ≤10 vs. \\> 10', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9287', 'groupIds': ['OG000'], 'paramType': '1-way Test, ChiSquare Approximation', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.0080', 'groupDescription': 'VAS at Post Operative Day 3; Follicles ≤10 vs. \\> 10', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'After 1 hrs but less than 3 days', 'description': 'Change in discomfort following oocyte retrieval with standardized anesthesia management as measured by verbal analogue scoring (0-10 scale) after immediate postoperative period (1 hrs) but prior to Embryo Transfer on 3rd postoperative day. Visual Analogue Scale (VAS) scores correlate to minimal (VAS 0-3), moderate (VAS 4-6) or severe (VAS ≥7) discomfort. Patients will record the type, dose, and timing of pain medicines in a diary to be returned at Embryo Transfer.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 100 parturients analyzed; divided into those who had less than, compared to more than 10 follicles on preoperative ultrasound image.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Analgesia Options', 'description': 'Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.\n\nFentanyl: 0.5, 1 mcg/kg\n\nAcetaminophen: Single + Oxycodone\n\nOxycodone: With Acetaminophen'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Analgesia Options', 'description': 'Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.\n\nFentanyl: 0.5, 1 mcg/kg\n\nAcetaminophen: Single + Oxycodone\n\nOxycodone: With Acetaminophen'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.54', 'spread': '4.61', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '100', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '95', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2010-09-13', 'size': 223844, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-12T17:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Assessment of immediate and delayed postoperative pain'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2014-10-05', 'resultsFirstSubmitDate': '2017-04-16', 'studyFirstSubmitQcDate': '2017-04-03', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-30', 'studyFirstPostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of Discomfort', 'timeFrame': 'PACU admission, 15, 30 and 60 min postprocedure, postoperative day 3', 'description': 'Change in discomfort following oocyte retrieval with standardized anesthesia management as measured by verbal analogue scoring (0-10 scale). VAS scores correlate to minimal (VAS 0-3), moderate (VAS 4-6) or severe (VAS ≥7) discomfort.'}], 'secondaryOutcomes': [{'measure': 'Amount of Discomfort Following Discharge Until Embryo Transfer', 'timeFrame': 'After 1 hrs but less than 3 days', 'description': 'Change in discomfort following oocyte retrieval with standardized anesthesia management as measured by verbal analogue scoring (0-10 scale) after immediate postoperative period (1 hrs) but prior to Embryo Transfer on 3rd postoperative day. Visual Analogue Scale (VAS) scores correlate to minimal (VAS 0-3), moderate (VAS 4-6) or severe (VAS ≥7) discomfort. Patients will record the type, dose, and timing of pain medicines in a diary to be returned at Embryo Transfer.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['assisted reproduction', 'postoperative pain', 'opioid'], 'conditions': ['Oocyte Retrieval', 'Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '12351295', 'type': 'RESULT', 'citation': 'Harnett MJ, Bhavani-Shankar K, Datta S, Tsen LC. In vitro fertilization-induced alterations in coagulation and fibrinolysis as measured by thromboelastography. Anesth Analg. 2002 Oct;95(4):1063-6, table of contents. doi: 10.1097/00000539-200210000-00050.'}, {'pmid': '2221417', 'type': 'RESULT', 'citation': 'Bader AM, Datta S, Moller RA, Covino BG. Acute progesterone treatment has no effect on bupivacaine-induced conduction blockade in the isolated rabbit vagus nerve. Anesth Analg. 1990 Nov;71(5):545-8. doi: 10.1213/00000539-199011000-00016.'}, {'pmid': '6650889', 'type': 'RESULT', 'citation': 'Datta S, Lambert DH, Gregus J, Gissen AJ, Covino BG. Differential sensitivities of mammalian nerve fibers during pregnancy. Anesth Analg. 1983 Dec;62(12):1070-2.'}]}, 'descriptionModule': {'briefSummary': 'The central objective of this study will be to evaluate the relationship between estrogen levels and the pain following oocyte retrieval in women undergoing in vitro fertilization.', 'detailedDescription': "Subject will undergo standard clinical protocols for the entire oocyte stimulation cycle and all assisted reproductive procedure decisions and algorithms will be decided entirely independent of this study.\n\nThe anesthetic and postoperative pain regimens will use the same agents and dose ranges used in clinical standard practice; however, the regimens will be standardized, so as to limit confounding variables. The study regimen for anesthesia will differ from the current, clinical standard by the mandated use of actual body weight (in current practice, actual, adjusted ideal, or ideal body weights are used), the use of fentanyl 1 mcg/kg IV (instead of 100 mcg for everyone), and the standardization of postoperative analgesia (noted below). The total amount of fentanyl, propofol, and postoperative drugs will be recorded.\n\nPostoperative analgesia will be standardized based on the subject's self reported verbal analogue score (VAS) and the timing of the report. The agents and timing used below differ from the current clinical standard by assessing VAS and responding with a certain regimen."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) I to III health status (moderate systemic disease),\n* Age between 18 and 50 yrs\n* Undergoing oocyte retrieval with intravenous general anesthesia.\n\nExclusion Criteria:\n\n* Refuse or withdraw their consent\n* Fail to adequately respond to IVF stimulations medications, and thus are not eligible for oocyte retrieval.'}, 'identificationModule': {'nctId': 'NCT03105518', 'briefTitle': 'Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction', 'orgStudyIdInfo': {'id': '2010-P-002310/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Analgesia options', 'description': 'Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.', 'interventionNames': ['Drug: Fentanyl', 'Drug: Acetaminophen', 'Drug: Oxycodone']}], 'interventions': [{'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['Sublimaze'], 'description': '0.5, 1 mcg/kg', 'armGroupLabels': ['Analgesia options']}, {'name': 'Acetaminophen', 'type': 'DRUG', 'otherNames': ['Tylenol'], 'description': 'Single + Oxycodone', 'armGroupLabels': ['Analgesia options']}, {'name': 'Oxycodone', 'type': 'DRUG', 'otherNames': ['Percocet'], 'description': 'With Acetaminophen', 'armGroupLabels': ['Analgesia options']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Lawrence C Tsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Chair, Faculty Development and Education; Associate Professor', 'investigatorFullName': 'Lawrence Ching Tsen', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}