Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-27 @ 9:42 PM
Study NCT ID:
NCT00235261
Status:
COMPLETED
Last Update Posted:
2007-08-17
First Post:
2005-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients After Hip Operations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, 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': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-08-16', 'studyFirstSubmitDate': '2005-10-06', 'studyFirstSubmitQcDate': '2005-10-07', 'lastUpdatePostDateStruct': {'date': '2007-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The total amount of morphine needed postoperatively from 0-4 h, and 0-24 h, administered by a patient controlled pain treatment. (PCA)'}], 'secondaryOutcomes': [{'measure': 'Pain score (VAS) at rest and at mobilisation.'}, {'measure': 'Postoperative nausea and vomiting.'}, {'measure': 'Sedation.'}, {'measure': 'Dizziness'}, {'measure': 'All measurements are taken at 2,4 and 24 h postoperatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Total hip replacement', 'Pregablin', 'Dexamethasone', 'Multimodal postoperative analgesia.'], 'conditions': ['Pain', 'Postoperative']}, 'descriptionModule': {'briefSummary': 'Patients scheduled for primary total hip replacement needs postoperative pain treatment: i.e. morphine. Unfortunately morphine has side-effects: 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 and improve the patients pain score after operation.', 'detailedDescription': 'We investigate the effect of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone on pain and morphine usage in the first 24 hours postoperatively in patients getting a new hip alloplastic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for primary total hip replacement in spinal anaesthesia\n* between the age of 55 and 75,\n* ASA 1-3, and with\n* BMI between 18 and 35.\n\nExclusion Criteria:\n\n* are unable to cooperate;\n* does not speak Danish;\n* has allergy for drugs used in the trial;\n* has drug and/or medicine abuse;\n* epilepsy;\n* diabetes treated with medicine;\n* treatment with systemic steroids within 4 weeks prior to the operation;\n* daily use of antacids;\n* daily use of analgesics except for NSAID, Cox2 inhibitors and Paracetamol;\n* known kidney disease;\n* use of antidepressants'}, 'identificationModule': {'nctId': 'NCT00235261', 'briefTitle': 'Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients After Hip Operations', '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 a Primary Total Hip Replacement', 'orgStudyIdInfo': {'id': 'SM3-05'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pregabalin', 'type': 'DRUG'}, {'name': 'Dexamethasone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2970', 'city': 'Hoersholm', 'state': 'Frederiksborg Amt', 'country': 'Denmark', 'facility': 'Department of anaesthesiology; Hoersholm Sygehus'}], 'overallOfficials': [{'name': 'Ole Mathiesen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark'}, {'name': 'Lars Steen Jacobsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Departmentof Anaesthesiology; Hørsholm Sygehus; Usserød Kongevej 102; 2970 Hørsholm; Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}}}}