Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT01094106
Status:
COMPLETED
Last Update Posted:
2020-08-18
First Post:
2010-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Infiltration Analgesia After Caesarean Section
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'matti.reinikainen@kuh.fi', 'phone': '+358447176681', 'title': 'Matti Reinikainen', 'organization': 'Kuopio University Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ropivacaine 0,75%', 'description': 'Patients undergoing caesarean section under spinal anaesthesia\n\nRopivacaine 0,75%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/ h/ 48h', 'otherNumAtRisk': 33, 'otherNumAffected': 1, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NaCl 0,9%', 'description': 'Patients undergoing caesarean section under spinal anaesthesia\n\nNaCl 0,9%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/h/48h', 'otherNumAtRisk': 34, 'otherNumAffected': 2, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Wound dressings becoming unpleasantly wet, resulting in termination of the study drug infusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Smarting of the wound', 'notes': 'Smarting of the wound, necessitating termination of the study drug infusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Demand of Rescue Analgesics (Oxycodone)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ropivacaine 0,75%', 'description': 'Patients undergoing caesarean section under spinal anaesthesia\n\nRopivacaine 0,75%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/ h/ 48h'}, {'id': 'OG001', 'title': 'NaCl 0,9%', 'description': 'Patients undergoing caesarean section under spinal anaesthesia\n\nNaCl 0,9%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/h/48h'}], 'classes': [{'categories': [{'measurements': [{'value': '47.5', 'spread': '20.9', 'groupId': 'OG000'}, {'value': '57.8', 'spread': '29.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'In a previous non-randomised study at our institution, the mean oxycodone consumption in the control group was 60.7 mg (SD, 22.2 mg) during the first 48 h after caesarean section. At α = 0.05, 31 patients would be needed in each group to achieve a power of 90% for detecting a 30% reduction in the need for rescue opioids, which we considered a clinically meaningful effect. We decided to enrol 70 patients. The final study population was 67 patients.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'The amount of oxycodone required 48 hours after operation. Oxycodone was administered when the strength of pain is over 3 on numeric rating scale (NRS) 0-10.', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Strength of Pain on Numerical Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ropivacaine 0,75%', 'description': 'Patients undergoing caesarean section under spinal anaesthesia\n\nRopivacaine 0,75%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/ h/ 48h'}, {'id': 'OG001', 'title': 'NaCl 0,9%', 'description': 'Patients undergoing caesarean section under spinal anaesthesia\n\nNaCl 0,9%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/h/48h'}], 'classes': [{'title': 'Highest recorded pain scores at rest, 0-6 h', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '6'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '7'}]}]}, {'title': 'Highest recorded pain scores at rest, 6-12 h', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '3.75', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}]}]}, {'title': 'Highest recorded pain scores at rest, 12-24 h', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '5'}]}]}, {'title': 'Highest recorded pain scores at rest, 24-36 h', 'categories': [{'measurements': [{'value': '2.25', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '4'}]}]}, {'title': 'Highest recorded pain scores at rest, 36-48 h', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Highest recorded pain scores when moving, 0-6 h', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '8'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '8'}]}]}, {'title': 'Highest recorded pain scores when moving, 6-12 h', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '7'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '7'}]}]}, {'title': 'Highest recorded pain scores when moving, 12-24 h', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '7'}, {'value': '5.75', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '6.5'}]}]}, {'title': 'Highest recorded pain scores when moving, 24-36 h', 'categories': [{'measurements': [{'value': '4.25', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '6'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '6'}]}]}, {'title': 'Highest recorded pain scores when moving, 36-48 h', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '4.5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '6'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons', 'groupDescription': 'Highest recorded pain scores at rest, 0-6 h', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.86', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons', 'groupDescription': 'Highest recorded pain scores at rest, 6-12 h', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.66', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons', 'groupDescription': 'Highest recorded pain scores at rest, 12-24 h', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons', 'groupDescription': 'Highest recorded pain scores at rest, 24-36 h', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.20', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons', 'groupDescription': 'Highest recorded pain scores at rest, 36-48 h', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.36', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons', 'groupDescription': 'Highest recorded pain scores when moving, 0-6 h', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.43', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons', 'groupDescription': 'Highest recorded pain scores when moving, 6-12 h', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.68', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons', 'groupDescription': 'Highest recorded pain scores when moving, 12-24 h', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons', 'groupDescription': 'Highest recorded pain scores when moving, 24-36 h', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons', 'groupDescription': 'Highest recorded pain scores when moving, 36-48 h', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '48 hours, divided to five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h)', 'description': 'Intensity of pain was recorded on a numerical rating scale (0-10), where higher scores mean more severe pain, during rest and when moving, for five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h); for each time interval, the highest recorded pain score was taken into account.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Nausea and Vomiting (PONV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ropivacaine 0,75%', 'description': 'Patients undergoing caesarean section under spinal anaesthesia\n\nRopivacaine 0,75%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/ h/ 48h'}, {'id': 'OG001', 'title': 'NaCl 0,9%', 'description': 'Patients undergoing caesarean section under spinal anaesthesia\n\nNaCl 0,9%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/h/48h'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.30', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '48 hours', 'description': 'The numbers of patients with at least mild nausea at any time post-operatively.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ropivacaine 0,75%', 'description': 'Postoperative wound infusion 15 mg /h / 48h\n\nRopivacaine 0,75%: Postoperative wound infusion 2 ml/ h/ 48h'}, {'id': 'FG001', 'title': 'NaCl 0,9%', 'description': 'Postoperative wound infusion with NaCl 0,9% 2 ml /h /48h\n\nNaCl 0,9%: Postoperative wound infusion 2 ml/h/48h'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Three patients were excluded after recruitment and randomisation, for the following reasons: For one patient, an emergency operation was needed before the scheduled operation time; for one patient, the hospital pharmacy was unable to provide the study drug in time, and for one patient, no study drug was initiated because of communication errors.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ropivacaine 0,75%', 'description': 'Patients undergoing caesarean section under spinal anaesthesia\n\nRopivacaine 0,75%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/ h/ 48h'}, {'id': 'BG001', 'title': 'NaCl 0,9%', 'description': 'Patients undergoing caesarean section under spinal anaesthesia\n\nNaCl 0,9%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/h/48h'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.1', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '30.9', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '30.5', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'Male', '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': 'Finland', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight, kg', 'classes': [{'categories': [{'measurements': [{'value': '75.8', 'spread': '12.6', 'groupId': 'BG000'}, {'value': '80.6', 'spread': '17.2', 'groupId': 'BG001'}, {'value': '78.2', 'spread': '15.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height, cm', 'classes': [{'categories': [{'measurements': [{'value': '162.4', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '162.9', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '162.6', 'spread': '6.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Dose of spinal bupivacaine, mg', 'classes': [{'categories': [{'measurements': [{'value': '11.9', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '11.7', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '11.8', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Length of operation, min', 'classes': [{'categories': [{'measurements': [{'value': '50.6', 'spread': '18.3', 'groupId': 'BG000'}, {'value': '46.6', 'spread': '13.8', 'groupId': 'BG001'}, {'value': '47.0', 'spread': '16.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'min', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-06', 'studyFirstSubmitDate': '2010-03-12', 'resultsFirstSubmitDate': '2020-07-05', 'studyFirstSubmitQcDate': '2010-03-25', 'lastUpdatePostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-06', 'studyFirstPostDateStruct': {'date': '2010-03-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Demand of Rescue Analgesics (Oxycodone)', 'timeFrame': '48 hours', 'description': 'The amount of oxycodone required 48 hours after operation. Oxycodone was administered when the strength of pain is over 3 on numeric rating scale (NRS) 0-10.'}], 'secondaryOutcomes': [{'measure': 'Strength of Pain on Numerical Rating Scale (NRS)', 'timeFrame': '48 hours, divided to five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h)', 'description': 'Intensity of pain was recorded on a numerical rating scale (0-10), where higher scores mean more severe pain, during rest and when moving, for five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h); for each time interval, the highest recorded pain score was taken into account.'}, {'measure': 'Postoperative Nausea and Vomiting (PONV)', 'timeFrame': '48 hours', 'description': 'The numbers of patients with at least mild nausea at any time post-operatively.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['postoperative pain', 'infiltration analgesia', 'ropivacaine', 'Caesarean Section'], 'conditions': ['Pain, Postoperative', 'Caesarean Section']}, 'descriptionModule': {'briefSummary': 'Infiltration of a local anesthetic into the surgical wound is a simple method to strive to control postoperative pain after surgery. In the investigators institution, this method is used quite often. However, there is a controversy regarding the analgesic efficacy. Moreover, the cost of the single use elastomeric pump used with this procedure is clearly higher than the costs of other routinely used analgesic methods.\n\nAccording to the investigators observations, infiltration of a local anesthetic into the surgical wound after caesarean section seems to reduce the need for rescue analgesics. However, the scientific evidence of the efficacy of this technique is weak. The investigators decided to conduct a prospective, controlled, randomised, double blind trial on this topic.\n\nThe hypothesis is that wound infiltration with local anesthetic will reduce postoperative pain and opioid consumption after caesarean section without major adverse effects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* volunteer\n* age over 18 years\n* spinal anesthesia\n* ASA 1-2\n* no allergy to used medications\n* no medications which have effect on pain perception\n\nExclusion Criteria:\n\n* patient's refusal to participate\n* marked systemic disease"}, 'identificationModule': {'nctId': 'NCT01094106', 'briefTitle': 'Infiltration Analgesia After Caesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'North Karelia Central Hospital'}, 'officialTitle': 'Local Infiltration Analgesia for Postoperative Pain After Caesarean Section. A Prospective, Randomised, Controlled Trial', 'orgStudyIdInfo': {'id': 'NCCHAne001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivacaine 0,75%', 'description': 'Postoperative wound infusion 15 mg /h / 48h', 'interventionNames': ['Drug: Ropivacaine 0,75%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NaCl 0,9%', 'description': 'Postoperative wound infusion with NaCl 0,9% 2 ml /h /48h', 'interventionNames': ['Drug: NaCl 0,9%']}], 'interventions': [{'name': 'Ropivacaine 0,75%', 'type': 'DRUG', 'description': 'Postoperative wound infusion 2 ml/ h/ 48h', 'armGroupLabels': ['Ropivacaine 0,75%']}, {'name': 'NaCl 0,9%', 'type': 'DRUG', 'description': 'Postoperative wound infusion 2 ml/h/48h', 'armGroupLabels': ['NaCl 0,9%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80880', 'city': 'Joensuu', 'country': 'Finland', 'facility': 'North Karelia Central hospital', 'geoPoint': {'lat': 62.60118, 'lon': 29.76316}}], 'overallOfficials': [{'name': 'Sakari Syväoja, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Carelia CH, Department of Anesthesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Karelia Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Sanna Kouhia', 'investigatorAffiliation': 'North Karelia Central Hospital'}}}}