Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
Study NCT ID:
NCT04330157
Status:
COMPLETED
Last Update Posted:
2021-07-30
First Post:
2020-03-30
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Inflammation and Postoperative Tramadol Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nneskov@gmail.com', 'phone': '+385996787250', 'title': 'Nenad Neskovic', 'organization': 'University hospital Osijek'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Adverse Effect', 'description': 'Adverse effect of tramadol', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 16, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Postoperative nausea and/or vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Analgesic Affect of Tramadol After Major Abdominal Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Score Before Tramadol Application', 'description': 'Before administration of tramadol to all patients who were extubated an NRS score was determined'}, {'id': 'OG001', 'title': 'NRS Score After Tramadol Application', 'description': '30 minutes after administration of tramadol to all patients who were extubated an NRS score was determined'}], 'classes': [{'title': '1st assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '9.5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4.25', 'upperLimit': '6'}]}]}, {'title': '2nd assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '6.5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': '3rd assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '5'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': '4th assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}]}]}, {'title': '5th assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'NRS was assessed before and 30 minutes after each tramadol dose during first 24 postoperative hours', 'description': 'Pain will be assessed before and half an hour after tramadol administration in awake patients by verbal Numeric Rating Scale. This scale has values from 0 to 10, where 0 means no pain and 10 means maximum pain.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'NRS score was determinated only in awake patients'}, {'type': 'PRIMARY', 'title': 'Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Before Tramadol - no Systemic Inflammation', 'description': 'NRS score in a patient who did not meet the criteria for systemic inflammation, before tramadol administration'}, {'id': 'OG001', 'title': 'NRS After Tramadol - no Systemic Inflammation', 'description': 'NRS score in a patient who did not meet the criteria for systemic inflammation, after tramadol administration'}, {'id': 'OG002', 'title': 'NRS Before Tramadol - With Systemic Inflammation', 'description': 'NRS score in a patient who meet the criteria for systemic inflammation, before tramadol administration'}, {'id': 'OG003', 'title': 'NRS After Tramadol - With Systemic Inflammation', 'description': 'NRS score in a patient who meet the criteria for systemic inflammation, after tramadol administration'}], 'classes': [{'title': '1st assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '10'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '5'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '7', 'upperLimit': '7'}, {'value': '7', 'groupId': 'OG003', 'lowerLimit': '6', 'upperLimit': '7'}]}]}, {'title': '2nd assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '3.57', 'upperLimit': '7.25'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4.25'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '5'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': '3rd assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '5'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1.25', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '4'}]}]}, {'title': '4th assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '7.25'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '3.5'}]}]}, {'title': '5th assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '5.75'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0.25', 'upperLimit': '3.57'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'NRS was assessed before and 30 minutes after each dose of tramadol in a first 24 postoperative hour', 'description': 'Differences in Numeric Rating Scale (NRS) in Patients with and without Systemic Inflammation. This scale has values from 0 to 10, where 0 means no pain and 10 means maximum pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'NRS was assessed only in awake patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients Included in the Study', 'description': 'The study included patients admitted to the ICU after major abdominal surgeries.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Not extubated within 24 h postoperatively', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Demographic Characteristics of the Patients', 'description': 'Demographic characteristics of the patients included and type of surgical procedures'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000', 'lowerLimit': '59', 'upperLimit': '73'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '28', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '43', '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'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '26.1', 'groupId': 'BG000', 'lowerLimit': '22.8', 'upperLimit': '28'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Smoking status', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ASA status', 'classes': [{'categories': [{'title': 'II', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'III', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'IV', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ASA I: A normal healthy patient; ASA II: A patient with severe systemic disease; ASA III: A patient with severe systemic disease; ASA IV: A patient with severe systemic disease that is a constant threat to life.', 'unitOfMeasure': 'Participants'}, {'title': 'Surgical procedure', 'classes': [{'categories': [{'title': 'Colorectal', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Gastric', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Small intestine', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Liver', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Pancreas', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Multiple resection', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-20', 'size': 94675, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-08T07:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'CRP, PCT. leukocyte count, lactate, arterial blood gas'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-10', 'studyFirstSubmitDate': '2020-03-30', 'resultsFirstSubmitDate': '2021-04-19', 'studyFirstSubmitQcDate': '2020-03-30', 'lastUpdatePostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-10', 'studyFirstPostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesic Affect of Tramadol After Major Abdominal Surgery', 'timeFrame': 'NRS was assessed before and 30 minutes after each tramadol dose during first 24 postoperative hours', 'description': 'Pain will be assessed before and half an hour after tramadol administration in awake patients by verbal Numeric Rating Scale. This scale has values from 0 to 10, where 0 means no pain and 10 means maximum pain.'}, {'measure': 'Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation', 'timeFrame': 'NRS was assessed before and 30 minutes after each dose of tramadol in a first 24 postoperative hour', 'description': 'Differences in Numeric Rating Scale (NRS) in Patients with and without Systemic Inflammation. This scale has values from 0 to 10, where 0 means no pain and 10 means maximum pain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative analgesia', 'tramadol', 'intensive care unit'], 'conditions': ['General Surgery']}, 'referencesModule': {'references': [{'pmid': '31004280', 'type': 'BACKGROUND', 'citation': 'Barakat A. Revisiting Tramadol: A Multi-Modal Agent for Pain Management. CNS Drugs. 2019 May;33(5):481-501. doi: 10.1007/s40263-019-00623-5.'}, {'pmid': '26574146', 'type': 'BACKGROUND', 'citation': 'He ZX, Chen XW, Zhou ZW, Zhou SF. Impact of physiological, pathological and environmental factors on the expression and activity of human cytochrome P450 2D6 and implications in precision medicine. Drug Metab Rev. 2015;47(4):470-519. doi: 10.3109/03602532.2015.1101131. Epub 2015 Nov 16.'}, {'pmid': '21724620', 'type': 'BACKGROUND', 'citation': 'Gerbershagen HJ, Rothaug J, Kalkman CJ, Meissner W. Determination of moderate-to-severe postoperative pain on the numeric rating scale: a cut-off point analysis applying four different methods. Br J Anaesth. 2011 Oct;107(4):619-26. doi: 10.1093/bja/aer195. Epub 2011 Jun 30.'}, {'pmid': '28537216', 'type': 'BACKGROUND', 'citation': 'Mallick P, Taneja G, Moorthy B, Ghose R. Regulation of drug-metabolizing enzymes in infectious and inflammatory disease: implications for biologics-small molecule drug interactions. Expert Opin Drug Metab Toxicol. 2017 Jun;13(6):605-616. doi: 10.1080/17425255.2017.1292251. Epub 2017 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'Patients will be admitted in the intensive care unit after major abdominal surgery. All patients will receive 100 mg of tramadol intravenously every 6 hours. Pain will be assessed before and half an hour after tramadol administration by verbal Numeric Rating Scale.', 'detailedDescription': 'To all patients included in the study from the blood sample taken prior to the operation the leukocytes counts, c-reactive protein (CRP), procalcitonin (PCT) and lactate level will be performed, as well as arterial blood gas analysis.\n\nAfter admission to the intensive care unit, all patients will receive 100 mg of tramadol intravenously every 6 hours. Pain will be assessed before and half an hour after tramadol administration by verbal Numeric Rating Scale (NRS). Pain score will be compared between patients with and without systemic inflammation. Systemic inflammation is defined as fulfilling at least two of the following major criteria: fever \\> 38 oC or hypothermia \\< 36 oC, tachycardia \\> 90 beats/minute, pCO2 in arterial blood \\< 4.3 kPa and leukocytes \\> 12.000/mm3 or \\< 4.000/mm3. Also, preoperative values of CRP \\> 50 mg/L and PCT \\> 0.5 ng/ml was also considered systemic inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study included patients admitted in the intensive care unit after major abdominal surgery performed with open laparotomy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective and emergency open abdominal surgery\n* ICU admission\n\nExclusion Criteria:\n\n* tramadol allergy\n* surgery performed laparoscopically\n* age younger of 18 years and older the 90 years'}, 'identificationModule': {'nctId': 'NCT04330157', 'briefTitle': 'Inflammation and Postoperative Tramadol Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Osijek University Hospital'}, 'officialTitle': 'The Influence of Systemic Inflammation on the Analgesic Effect of Tramadol After Major Abdominal Surgery', 'orgStudyIdInfo': {'id': 'OsijekUH-6'}}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Osijek', 'country': 'Croatia', 'facility': 'University hospital centre Osijek', 'geoPoint': {'lat': 45.55066, 'lon': 18.6942}}], 'overallOfficials': [{'name': 'Nenad Nešković', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthesiologyst'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osijek University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}