Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-02-25 @ 8:18 PM
Study NCT ID:
NCT02014766
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2013-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supraclavicular Versus Interscalene Block
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-12', 'studyFirstSubmitDate': '2013-12-06', 'studyFirstSubmitQcDate': '2013-12-12', 'lastUpdatePostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain duration', 'timeFrame': 'at 24h after operation'}], 'secondaryOutcomes': [{'measure': 'diaphragmatic movement', 'timeFrame': 'preoperative, after block(at 30 min), after operation'}, {'measure': 'motor block', 'timeFrame': 'after block(at 30 min), after operation, at 24h'}, {'measure': 'paresthesia', 'timeFrame': 'after block(at 30min), after operation, at 24h'}, {'measure': 'complications', 'timeFrame': 'after block (at 30 min), after operation, at 24h'}, {'measure': 'supplemental analgesia', 'timeFrame': 'after operation, at 24h'}, {'measure': 'pain score', 'timeFrame': 'at 24h'}, {'measure': 'patient satisfaction', 'timeFrame': 'at 24h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '20565394', 'type': 'BACKGROUND', 'citation': 'Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.'}, {'pmid': '20686013', 'type': 'RESULT', 'citation': 'Liu SS, Gordon MA, Shaw PM, Wilfred S, Shetty T, Yadeau JT. A prospective clinical registry of ultrasound-guided regional anesthesia for ambulatory shoulder surgery. Anesth Analg. 2010 Sep;111(3):617-23. doi: 10.1213/ANE.0b013e3181ea5f5d. Epub 2010 Aug 4.'}]}, 'descriptionModule': {'briefSummary': 'We hypothesize that both ultrasound-guided supraclavicular and interscalene block provide similar analgesia after shoulder surgery.', 'detailedDescription': 'Interscalene block provides effective postoperative analgesia after shoulder surgery. However, it can be associated with significant risk including the phrenic nerve palsy. Previous study reported that ultrasound-guided interscalene and supraclavicular blocks are effective and safe for shoulder arthroscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAmerican Society of Anesthesiologists physical status I-III inpatients undergoing shoulder surgery\n\nExclusion Criteria:\n\npregnancy, severe respiratory disease, preexisting neuropathy in the operated arm, coagulopathy, allergy to study medication'}, 'identificationModule': {'nctId': 'NCT02014766', 'briefTitle': 'Supraclavicular Versus Interscalene Block', 'organization': {'class': 'OTHER', 'fullName': 'Cheju Halla General Hospital'}, 'officialTitle': 'A Randomized Comparison of Ultrasound-guided Supraclavicular and Interscalene Block After Shoulder Surgery', 'orgStudyIdInfo': {'id': 'Inter1'}, 'secondaryIdInfos': [{'id': '2013-M10', 'type': 'OTHER', 'domain': 'Cheju Halla General Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Interscalene block', 'description': 'Interscalene block is performed under ultrasound guidance. Linear probe is placed on the ipsilateral interscalene groove visualizing the brachial plexus located between anterior and middle scalene muscles. Using in-plane technique, an insulated needle is advanced into the brachial plexus sheath, into which 20 ml of 0.375% ropivacaine is injected.', 'interventionNames': ['Procedure: Interscalene block']}, {'type': 'EXPERIMENTAL', 'label': 'Supraclavicular block', 'description': 'Supraclavicular block is performed under ultrasound guidance. Linear probe is placed on the ipsilateral supraclavicular fossa visualizing the brachial plexus located lateral to the subclavian artery. Using in-plane technique, an insulated needle is advanced into the brachial plexus sheath, into which 20 ml of 0.375% ropivacaine is injected.', 'interventionNames': ['Procedure: Supraclavicular block']}], 'interventions': [{'name': 'Interscalene block', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided interscalene block is performed.', 'armGroupLabels': ['Interscalene block']}, {'name': 'Supraclavicular block', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided supraclavicular block is performed', 'armGroupLabels': ['Supraclavicular block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '670-744', 'city': 'Jeju City', 'state': 'Jeju Self-governing Province', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Chunwoo Yang, MD', 'role': 'CONTACT', 'email': 'everycw@daum.net', 'phone': '82-10-2670-0520'}, {'name': 'Chunwoo Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cheju Halla General Hopsital', 'geoPoint': {'lat': 33.50972, 'lon': 126.52194}}], 'centralContacts': [{'name': 'Chunwoo Yang, MD', 'role': 'CONTACT', 'email': 'everycw@daum.net', 'phone': '82-10-2670-0520'}], 'overallOfficials': [{'name': 'Chunwoo Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dep. of anesthesia and pain medicine, Cheju Halla General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cheju Halla General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}