Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-03-04 @ 8:38 PM
Study NCT ID:
NCT03011905
Status:
COMPLETED
Last Update Posted:
2020-09-21
First Post:
2016-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rebound Pain After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block
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': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D000077613', 'term': 'Etoricoxib'}, {'id': 'D010098', 'term': 'Oxycodone'}, {'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'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'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-18', 'studyFirstSubmitDate': '2016-12-21', 'studyFirstSubmitQcDate': '2017-01-04', 'lastUpdatePostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences between groups in highest pain scores first 24 hours after surgery', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Differences in pain scores after 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours', 'timeFrame': '30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours'}, {'measure': 'Differences in pain scores after 36 hours, 3 days, 7 days, 6 weeks', 'timeFrame': '36 hours, 3 days, 7 days, 6 weeks'}, {'measure': 'Differences in pain scores after 6 months and 1 year', 'timeFrame': '6 months and 1 year'}, {'measure': 'Differences in analgesic consumption', 'timeFrame': '1 hours, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours, 1 week, 6 weeks, 6 months, 1 year'}, {'measure': 'Differences in block duration', 'timeFrame': '20 hours'}, {'measure': 'Differences between groups in sedation postoperatively assessed with Likert scale', 'timeFrame': '30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours', 'description': 'Likert scale'}, {'measure': 'Differences between groups in sleep quality assessed with Likert scale', 'timeFrame': '24 hours', 'description': 'Likert scale'}, {'measure': 'Differences between groups in nausea postoperatively assessed with Likert scale', 'timeFrame': '30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours', 'description': 'Likert scale'}, {'measure': 'Differences between groups in vomiting postoperatively assessed with Likert scale', 'timeFrame': '30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours', 'description': 'Likert scale'}, {'measure': 'Differences between groups in itching postoperatively assessed with Likert scale', 'timeFrame': '30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours', 'description': 'Likert scale'}, {'measure': 'Differences in time to first pain score under 4 after block resolution', 'timeFrame': '7 days'}, {'measure': 'Differences in side effects', 'timeFrame': '1 year'}, {'measure': 'Differences in Patient Rated Wrist/Hand Evaluation (PRWHE) scores after 6 weeks', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Brachial Plexus Block', 'Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '32472958', 'type': 'DERIVED', 'citation': 'Holmberg A, Hassellund SS, Draegni T, Nordby A, Ottesen FS, Gulestol A, Raeder J. Analgesic effect of intravenous dexamethasone after volar plate surgery for distal radius fracture with brachial plexus block anaesthesia: a prospective, double-blind randomised clinical trial. Anaesthesia. 2020 Nov;75(11):1448-1460. doi: 10.1111/anae.15111. Epub 2020 May 30.'}]}, 'descriptionModule': {'briefSummary': 'Many patients have strong pain at brachial plexus block resolution after operations for distal radius fractures with a volar plate. This study investigates if a single dose of dexamethasone in addition to a standard pain regime have an effect on postoperative pain. The primary endpoint is difference in the highest pain score first 24 hours after surgery. The investigators will also look at pain scores and analgesics consumption first few hours after surgery and at different times up to 2 years after surgery.', 'detailedDescription': 'This double-blind randomized clinical study evaluates pain, analgesic consumption and different measurements of patients satisfaction after operations for distal radius fractures with a volar plate in the day-care surgery unit. All patients will receive paracetamol and etoricoxib as oral premedication. Patients will be operated in infraclavicular brachial plexus block with ropivacaine 7,5 mg/ml. Patients in the intervention group will receive a single dose of 16 mg dexamethasone during the operation. Patients in the control group will receive NaCl iv.\n\nAfter surgery, iv and oral rapid release oxycodone as needed while in hospital. After discharge (after 2-4 hours), etoricoxib for 2 days, controlled release oxycodone, total of 3 doses. Rapid release oxycodone as needed.\n\nPatients will be followed up by telephone interviews at different times after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Distal radius fracture planned for operation with a volar plate\n* 0-20 days after trauma\n* AO classification A, B, and C\n* ASA 1 and 2\n* Age 18-65\n* BMI 18-35\n* Able to communicate in Norwegian\n\nExclusion Criteria:\n\n* Chronic pain\n* Other injuries\n* Pregnancy\n* Known allergic reactions to medicines used in the study'}, 'identificationModule': {'nctId': 'NCT03011905', 'briefTitle': 'Rebound Pain After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Rebound Pain at Block Resolution After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block', 'orgStudyIdInfo': {'id': '2016/599/REK sør-øst C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexamethasone', 'description': 'Single dose of dexamethasone (Dexagalen) 16 mg iv during operation.', 'interventionNames': ['Drug: Dexamethasone', 'Drug: Paracetamol', 'Drug: EtoriCoxib', 'Drug: Oxycodone', 'Drug: Ropivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Single dose of NaCl, 4 ml, iv during operation.', 'interventionNames': ['Drug: NaCl (Control)', 'Drug: Paracetamol', 'Drug: EtoriCoxib', 'Drug: Oxycodone', 'Drug: Ropivacaine']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['DexaGalen'], 'description': '4 ml DexaGalen 4 mg/ml', 'armGroupLabels': ['Dexamethasone']}, {'name': 'NaCl (Control)', 'type': 'DRUG', 'otherNames': ['NaCl'], 'description': '4 ml NaCl 9 mg/ml', 'armGroupLabels': ['Control']}, {'name': 'Paracetamol', 'type': 'DRUG', 'description': 'Premedication and as needed after operation', 'armGroupLabels': ['Control', 'Dexamethasone']}, {'name': 'EtoriCoxib', 'type': 'DRUG', 'otherNames': ['Arcoxia'], 'description': 'Premedication and first 2 postoperative days.', 'armGroupLabels': ['Control', 'Dexamethasone']}, {'name': 'Oxycodone', 'type': 'DRUG', 'otherNames': ['OxyContin', 'OxyNorm'], 'description': 'Total of 3 doses of OxyContin postoperatively. OxyNorm as needed.', 'armGroupLabels': ['Control', 'Dexamethasone']}, {'name': 'Ropivacaine', 'type': 'DRUG', 'description': 'In brachial plexus block', 'armGroupLabels': ['Control', 'Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0540', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo Universitetssykehus, Ullevaal, dept of anaesthesiology, legevakten', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Anne Holmberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Anne Holmberg', 'investigatorAffiliation': 'Oslo University Hospital'}}}}