Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT00210158
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Intraoperative Nitrous Oxide and Postoperative Pain for Patients With Current Opioid Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000388', 'term': 'Air'}, {'id': 'D050768', 'term': 'Protoporphyrinogen Oxidase'}], 'ancestors': [{'id': 'D001272', 'term': 'Atmosphere'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D044925', 'term': 'Oxidoreductases Acting on CH-CH Group Donors'}, {'id': 'D010088', 'term': 'Oxidoreductases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 's.mathoulin@bordeaux.unicancer.fr', 'phone': '+33 5 56 33 33 33', 'title': 'Simone Mathoulin-Pélissier, Director of Clinical Trials Unit', 'organization': 'Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '48 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Air Arm (Reference)', 'description': 'Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen.\n\nAir: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Protox Arm (Experimental)', 'description': 'Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.\n\nProtox: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post-operative Morphine Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Air Arm (Reference)', 'description': 'Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen.\n\nAir: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen.'}, {'id': 'OG001', 'title': 'Protox Arm (Experimental)', 'description': 'Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.\n\nProtox: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.6', 'spread': '51.2', 'groupId': 'OG000'}, {'value': '44.8', 'spread': '46.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.7', 'ciLowerLimit': '-23.4', 'ciUpperLimit': '42.8', 'groupDescription': 'T-test for a difference of means, assuming independant samples and unequal variances', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Between surgery and up to 48 hours', 'description': 'Morphine consumption (mg) during PCA (Patient Controlled Analgesia)', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a record of morphine consumption (mg) during PCA (Patient Controlled Analgesia)'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Post-operative Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Air Arm (Reference)', 'description': 'Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen.\n\nAir: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen.'}, {'id': 'OG001', 'title': 'Protox Arm (Experimental)', 'description': 'Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.\n\nProtox: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Between surgery and up to 48 hours', 'description': 'Pain is measured using a visual analog scale (VAS), ranging from 0 (no pain) to 100 (worst pain ever).\n\nA participant is considered to have pain if VAS score is \\>= 40.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a VAS score record available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Air Arm (Reference)', 'description': 'Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen.\n\nAir: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen.'}, {'id': 'FG001', 'title': 'Protox Arm (Experimental)', 'description': 'Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.\n\nProtox: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Air Arm (Reference)', 'description': 'Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen.\n\nAir: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen.'}, {'id': 'BG001', 'title': 'Protox Arm (Experimental)', 'description': 'Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.\n\nProtox: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '61.6', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '63.6', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '62.6', 'spread': '2.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2006-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2005-09-12', 'resultsFirstSubmitDate': '2025-08-20', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-20', 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative Morphine Consumption', 'timeFrame': 'Between surgery and up to 48 hours', 'description': 'Morphine consumption (mg) during PCA (Patient Controlled Analgesia)'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants With Post-operative Pain', 'timeFrame': 'Between surgery and up to 48 hours', 'description': 'Pain is measured using a visual analog scale (VAS), ranging from 0 (no pain) to 100 (worst pain ever).\n\nA participant is considered to have pain if VAS score is \\>= 40.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Current opioid treatment', 'Nitrous oxide', 'Chronic pain', 'Opioid therapy', 'Postoperative hyperalgesia', 'Acute opioid tolerance'], 'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'Peroperative opioids are known to induce N-Methyl-D-Aspartate dependent enhancement of postoperative hyperalgesia. For patients with current opioid treatment, these phenomena could be exagerated and could produce greater postoperative opioid consumption and higher pain score. Since Nitrous oxide has anti- N-Methyl-D-Aspartate properties, the aim of this study was to evaluate, in patients with current opioid treatment, the effects of peroperative Nitous oxide on postoperative opioid consumption and pain score, after vertebroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Older than 18 years\n* Current opioid treatment \\> 1 month\n* patients scheduled to undergo vertebroplasty with general anesthesia'}, 'identificationModule': {'nctId': 'NCT00210158', 'acronym': 'PROTOX', 'briefTitle': 'Intraoperative Nitrous Oxide and Postoperative Pain for Patients With Current Opioid Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Institut Bergonié'}, 'officialTitle': 'Effects of Intraoperative Nitrous Oxide on Postoperative Pain for Patients With Current Opioid Treatment After Vertebroplasty.', 'orgStudyIdInfo': {'id': 'IB2005-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Air arm (Reference)', 'description': 'Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen.', 'interventionNames': ['Procedure: Air']}, {'type': 'EXPERIMENTAL', 'label': 'Protox Arm (Experimental)', 'description': 'Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.', 'interventionNames': ['Procedure: Protox']}], 'interventions': [{'name': 'Air', 'type': 'PROCEDURE', 'description': 'Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen.', 'armGroupLabels': ['Air arm (Reference)']}, {'name': 'Protox', 'type': 'PROCEDURE', 'description': 'Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.', 'armGroupLabels': ['Protox Arm (Experimental)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonié - Centre Régional de Luttre Contre le Cancer DE Bordeaux et du Sud Ouest', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'Fabrice Lakdja, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Bergonié'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Bergonié', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}