Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT00209495
Status:
COMPLETED
Last Update Posted:
2008-02-29
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Paracetamol,Pregabalin and Dexamethasone on Pain and Opioid Requirements in Postoperative Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-28', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2008-02-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The total amount of morphine needed postoperatively form 0 - 4 h, and 0 - 24 h, administered by the patient controlled pain treatment. (PCA)', 'timeFrame': '0 - 24h'}], 'secondaryOutcomes': [{'measure': 'Pain Score (VAS) at rest and at mobilisation.', 'timeFrame': '0 - 24h'}, {'measure': 'Postoperative nausea and vomiting.', 'timeFrame': '0 - 24h'}, {'measure': 'Sedation.', 'timeFrame': '0 - 24h'}, {'measure': 'Dizziness.', 'timeFrame': '0 - 24h'}, {'measure': 'All measurements are taken at 2, 4 and 24 h postoperatively.', 'timeFrame': '0 - 24h'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Abdominal hysterectomy', 'Pregabalin', 'Dexamethasone', 'Multimodal postoperative analgesia'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'Women scheduled for abdominal hysterectomy needs postoperative pain treatment, i.e. morphine. Unfortunately morphine has side-effect: nausea, vomiting, sedation and dizziness, which is unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine.', 'detailedDescription': 'Combinations of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone is investigated. Primary outcome is 24 hours morphine usage.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women scheduled for abdominal hysterectomy, between the age of 18 and 75, ASA 1-2\n* BMI between 18-32.\n\nExclusion Criteria:\n\nPatients who:\n\n* Are unable to cooperate\n* Has cancer ovarian\n* Does not speak Danish\n* Has allergy for drugs used in the trial\n* Has drug and medicine abuse\n* Epilepsy\n* Diabetes treated with medicine\n* Chronic pain condition\n* Daily use of antacids or analgesic\n* Known kidney disease\n* Use of antidepressive'}, 'identificationModule': {'nctId': 'NCT00209495', 'briefTitle': 'Effect of Paracetamol,Pregabalin and Dexamethasone on Pain and Opioid Requirements in Postoperative Patients', 'organization': {'class': 'OTHER', 'fullName': 'Glostrup University Hospital, Copenhagen'}, 'officialTitle': 'Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Abdominal Hysterectomy.', 'orgStudyIdInfo': {'id': 'SM1-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'A', 'interventionNames': ['Drug: Pregabalin; Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Pregabalin', 'interventionNames': ['Drug: Pregabalin; Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'Pregabalin + dexamethasone', 'interventionNames': ['Drug: Pregabalin; Dexamethasone']}], 'interventions': [{'name': 'Pregabalin; Dexamethasone', 'type': 'DRUG', 'description': 'Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg', 'armGroupLabels': ['A', 'B', 'C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Glostrup Municipality', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Operations og Anæstesiologisk afd. Y, KAS Glostrup', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}, {'zip': '7400', 'city': 'Herning', 'country': 'Denmark', 'facility': 'Herning Centralsygehus', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}], 'overallOfficials': [{'name': 'Ole Mathiesen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}}}}