Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT01025102
Status:
COMPLETED
Last Update Posted:
2013-04-02
First Post:
2009-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Addition of Sufentanil Interscalene Block in 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': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-30', 'studyFirstSubmitDate': '2009-12-02', 'studyFirstSubmitQcDate': '2009-12-02', 'lastUpdatePostDateStruct': {'date': '2013-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to experience of moderate to severe postoperative pain', 'timeFrame': 'On day of surgery and 1., 2. and 3. postop. day'}], 'secondaryOutcomes': [{'measure': 'Side effects', 'timeFrame': 'On day of surgery and 1., 2. and. 3. postop. day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Postoperative Pain', 'Shoulder Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effects and side effects of interscale block performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery.', 'detailedDescription': 'The purpose of this study is to compare the duration of postoperative analgesia and supplemental opioid consumption and side effects of interscale block performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-III\n* Age 18-80\n* Shoulder surgery performed under interscalene block and general anesthesia\n\nExclusion Criteria:\n\n* Contraindication of interscalene block\n* Severe chronic obstructive lung disease\n* Non-cooperative patient\n* Intolerance to opioids\n* Pregnancy\n* Rheumatoid arthritis and diabetes with peripheral polyneuropathy\n* Chronic pain or daily opioid intake'}, 'identificationModule': {'nctId': 'NCT01025102', 'briefTitle': 'The Addition of Sufentanil Interscalene Block in Shoulder Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Frederiksberg University Hospital'}, 'officialTitle': 'Phase III Study of the Addition of Sufentanil to Interscalene Block in Shoulder Surgery', 'orgStudyIdInfo': {'id': 'gymoese007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Naropin 0.1%', 'interventionNames': ['Drug: Naropin 0.1% cum sufentanil']}], 'interventions': [{'name': 'Naropin 0.1% cum sufentanil', 'type': 'DRUG', 'otherNames': ['Local analgetic', 'Ropivacain'], 'description': '20ml of Naropin 0.1% cum sufentanil 1mikrog per ml', 'armGroupLabels': ['Naropin 0.1%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Frederiksberg', 'state': 'Frederiksberg', 'country': 'Denmark', 'facility': 'Anesthetic Clinic, Frederiksberg University Hospital', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}], 'overallOfficials': [{'name': 'Bent G Jørgensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthetic Clinic, Frederiksberg University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bent Gymoese Jorgensen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Bent Gymoese Jorgensen', 'investigatorAffiliation': 'Frederiksberg University Hospital'}}}}