Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-02 @ 6:48 AM
Study NCT ID:
NCT03541759
Status:
COMPLETED
Last Update Posted:
2018-06-01
First Post:
2018-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Management After Elective Shoulder Surgery
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': 'D004091', 'term': 'Hydromorphone'}, {'id': 'D010892', 'term': 'Pirinitramide'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'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': 'D007540', 'term': 'Isonipecotic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-31', 'studyFirstSubmitDate': '2018-05-17', 'studyFirstSubmitQcDate': '2018-05-29', 'lastUpdatePostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain management after elective shoulder surgery', 'timeFrame': '6 months', 'description': 'Comparison of hydromorphone versus piritramide using the numeric rating scale (NRS; range 0 - 10 points; level 0 representing no pain; level 10 representing the highest pain level)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elective shoulder surgery, hydromorphone, piritramide'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Postoperative pain management plays an important role in elective shoulder surgery. The aim of this randomized quantitative study is to compare two frequently used postoperative pain regimes (hydromorphone versus piritramide) regarding onset and duration after the effectiveness of the single-shot interscalene block has diminished.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients undergoing elective shoulder surgery with a single-shot interscalene plexus brachialis block in addition to general anesthesia\n* patients aged 18-99 years\n* patients being capable of giving an informed consent to participation in this study\n\nExclusion Criteria:\n\n* patients aged below 18 years\n* patients with decompensated liver, heart or renal insufficiency\n* patients with any kind of lung disease\n* patients with a chronic pain syndrome\n* patients with a previous pain medication with more than 3 drugs over more than 3 months'}, 'identificationModule': {'nctId': 'NCT03541759', 'briefTitle': 'Pain Management After Elective Shoulder Surgery', 'organization': {'class': 'OTHER', 'fullName': 'AUVA Traumazentrum Vienna Site UKH Meidling'}, 'officialTitle': 'Pain Management After Elective Shoulder Surgery: A Randomized Quantitative Study Comparing Hydromorphone With Piritramide', 'orgStudyIdInfo': {'id': '5/18-Anesthesiology'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hydromorphone', 'description': 'Hydromorphone Hcl 4 milligram (mg) Tab 2 times after surgery as basic medication. Hydromorphone Hcl 2.6mg maximum 2 per 24h when numeric rating scale (NRS) \\> 5.', 'interventionNames': ['Drug: Hydromorphone Hcl 4Mg Tab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Piritramide', 'description': 'Piritramide 15mg s.c. 2 times after surgery as basic medication. Piritramide 7.5mg s.c. maximum 2 per 24h when numeric rating scale (NRS) \\> 5.', 'interventionNames': ['Drug: Piritramide 15mg s.c.']}], 'interventions': [{'name': 'Hydromorphone Hcl 4Mg Tab', 'type': 'DRUG', 'otherNames': ['Hydal retard 4Mg'], 'description': 'Hydal retard 4Mg Tab 2 times after surgery as basic medication. Hydal retard 2.6Mg maximum 2 per 24h when NRS \\> 5.', 'armGroupLabels': ['Hydromorphone']}, {'name': 'Piritramide 15mg s.c.', 'type': 'DRUG', 'otherNames': ['Dipidolor 15mg s.c.'], 'description': 'Dipidolor 15mg s.c. 2 times after surgery as basic medication. Dipidolor 7.5mg s.c. maximum 2 per 24h when NRS \\> 5.', 'armGroupLabels': ['Piritramide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1120', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Austrian Workers Compensation Board Trauma Center Vienna Meidling', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Heinz Steltzer, MD, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Trauma Center Vienna Meidling'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AUVA Traumazentrum Vienna Site UKH Meidling', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sandra Boesmueller, MD, PhD', 'investigatorAffiliation': 'AUVA Traumazentrum Vienna Site UKH Meidling'}}}}