Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2026-02-11 @ 11:48 AM
Study NCT ID:
NCT02389361
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2015-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Oral Zaldiar With Intravenous Paracetamol and Tramadol
Sponsor:
Organization:
Raw JSON
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The VAS range are between 0 and 10. A worse outcome was defined as VAS \\> 4. The VAS use units on a scale.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group Z', 'description': 'Postoperative Analgesia with Zaldiar\n\nZaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)'}, {'id': 'FG001', 'title': 'Group PT', 'description': 'Postoperative Analgesia with Paracetamol-Tramadol\n\nParacetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group Z', 'description': 'Postoperative Analgesia with Zaldiar\n\nZaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)'}, {'id': 'BG001', 'title': 'Group PT', 'description': 'Postoperative Analgesia with Paracetamol-Tramadol\n\nParacetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol'}, {'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': '14', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.08', 'spread': '16.42', 'groupId': 'BG000'}, {'value': '62.41', 'spread': '14.51', 'groupId': 'BG001'}, {'value': '57.19', 'spread': '15.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-24', 'studyFirstSubmitDate': '2015-02-27', 'resultsFirstSubmitDate': '2015-06-22', 'studyFirstSubmitQcDate': '2015-03-10', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-07-18', 'studyFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Pain', 'timeFrame': 'In recovery room', 'description': 'Difference between groups in term of analgesia (as measured by Visual Analog Scale: VAS). The VAS range are between 0 and 10. A worse outcome was defined as VAS \\> 4. The VAS use units on a scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a classical intravenous protocol with paracetamol and tramadol. Second is an oral protocol with Zaldiar (combination of paracetamol and tramadol).', 'detailedDescription': 'Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a classical intravenous protocol with paracetamol and tramadol. This is the classical approach. Second is an oral protocol with Zaldiar (combination of paracetamol and tramadol). This is the new approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients incoming for inguinal hernia repair\n\nExclusion Criteria:\n\n* Preoperative abuse of analgesics'}, 'identificationModule': {'nctId': 'NCT02389361', 'briefTitle': 'Comparison of Oral Zaldiar With Intravenous Paracetamol and Tramadol', 'organization': {'class': 'OTHER', 'fullName': 'Astes'}, 'officialTitle': 'ZIH Study : Comparison of Oral Zaldiar (Combination of Paracetamol and Tramadol) With Intravenous Paracetamol and Tramadol for Postoperative Analgesia After Inguinal Hernia Repair', 'orgStudyIdInfo': {'id': 'ASTES - ZIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group Z', 'description': 'Postoperative Analgesia with Zaldiar', 'interventionNames': ['Drug: Zaldiar']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group PT', 'description': 'Postoperative Analgesia with Paracetamol-Tramadol', 'interventionNames': ['Drug: Paracetamol-Tramadol']}], 'interventions': [{'name': 'Zaldiar', 'type': 'DRUG', 'otherNames': ['Oral Zaldiar'], 'description': 'Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)', 'armGroupLabels': ['Group Z']}, {'name': 'Paracetamol-Tramadol', 'type': 'DRUG', 'otherNames': ['Intravenous Paracetamol and Tramadol'], 'description': 'Postoperative analgesia with intravenous Paracetamol and Tramadol', 'armGroupLabels': ['Group PT']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Eric Deflandre', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Eric DEFLANDRE, MD, FCCP', 'investigatorFullName': 'Eric DEFLANDRE, MD, PhD, FCCP', 'investigatorAffiliation': 'Astes'}}}}