Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2026-01-19 @ 12:23 PM
Study NCT ID:
NCT00510666
Status:
COMPLETED
Last Update Posted:
2009-03-31
First Post:
2007-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Butorphanol and Tramadol Associated Patient-Controlled Analgesia (PCA) After Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}], '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'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D002077', 'term': 'Butorphanol'}, {'id': 'D014147', 'term': 'Tramadol'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}]}}, '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': 841}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-30', 'studyFirstSubmitDate': '2007-08-01', 'studyFirstSubmitQcDate': '2007-08-01', 'lastUpdatePostDateStruct': {'date': '2009-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS pain scoring;', 'timeFrame': '5 months'}], 'secondaryOutcomes': [{'measure': "VAS sedation scoring; VAS happiness scoring; Adverse effects; Patient's overall conditions.", 'timeFrame': '5 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pain, Postoperative', 'Analgesics, Opioid', 'Analgesia, Patient-Controlled', 'Pain Measurement'], 'conditions': ['Postoperative Pain', 'Hysterectomy']}, 'referencesModule': {'references': [{'pmid': '19122548', 'type': 'RESULT', 'citation': 'Wang F, Shen X, Liu Y, Xu S, Guo X. Continuous infusion of butorphanol combined with intravenous morphine patient-controlled analgesia after total abdominal hysterectomy: a randomized, double-blind controlled trial. Eur J Anaesthesiol. 2009 Jan;26(1):28-34. doi: 10.1097/EJA.0b013e32831a6aa2.'}]}, 'descriptionModule': {'briefSummary': 'Intravenous patient-controlled analgesia (PCA) is a popular technique for postoperative pain management. Although several drugs are recognized as effective therapeutic options, optimal selection of drugs in hysterectomy patients underwent different anesthesia treatments remains unknown explicitly. The investigators hypothesized that butorphanol and tramadol can produce different analgesic effects with intravenous PCA after abdominal hysterectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status I-II\n* Chinese\n* 19-64yr\n* Uterus myoma\n\nExclusion Criteria:\n\n* Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records.\n* Participants younger than 18yr，older than 65yr or pregnancy was eliminated.\n* Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study.\n* Those who were not willing to or could not finish the whole study at any time.\n* Any patient who exhibited a combative or incoherent state of PCA analgesia would be excluded from the study.\n* Allergy to local anesthetics.\n* Failed to perform the epidural catheterization.\n* Those who demonstrated significant nerve-associated side effects from the insertion of the epidural needle.'}, 'identificationModule': {'nctId': 'NCT00510666', 'acronym': 'BATPCAH', 'briefTitle': 'Comparison of Butorphanol and Tramadol Associated Patient-Controlled Analgesia (PCA) After Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'Butorphanol and Tramadol for Morphine PCA Pain Management After Total Hysterectomy', 'orgStudyIdInfo': {'id': 'NMU-2579-3FW'}, 'secondaryIdInfos': [{'id': 'NMU2007092'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Butorphanol basal infusion adjunct to morphine PCA', 'interventionNames': ['Drug: Butorphanol tartrate']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Saline infusion adjunct to morphine PCA', 'interventionNames': ['Drug: Saline']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Premedication of Tramadol', 'interventionNames': ['Drug: Tramadol Hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Preemptive saline for morphine PCA', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Saline', 'type': 'DRUG', 'otherNames': ['SA'], 'description': 'Saline infusion adjunct to morphine PCA pump', 'armGroupLabels': ['2']}, {'name': 'Butorphanol tartrate', 'type': 'DRUG', 'otherNames': ['BT'], 'description': 'Butorphanol was delivered at a continuous infusion manner adjunct to morphine PCA pump', 'armGroupLabels': ['1']}, {'name': 'Tramadol Hydrochloride', 'type': 'DRUG', 'otherNames': ['TH'], 'description': '100mg tramadol was used preemptively to morphine PCA pump', 'armGroupLabels': ['3']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['PS'], 'description': 'Preemptive saline as a control group to tramadol one', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210004', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Maternal and Child Care Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'XiaoFeng Shen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'HRSA/Maternal and Child Health Bureau', 'class': 'FED'}], 'responsibleParty': {'oldNameTitle': 'XiaoFeng Shen', 'oldOrganization': 'Nanjing Maternal and Child Health Hospital'}}}}