Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2026-03-01 @ 5:17 PM
Study NCT ID:
NCT03877835
Status:
COMPLETED
Last Update Posted:
2021-01-07
First Post:
2019-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Outcome measures will be performed by an independent assessor'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-04', 'studyFirstSubmitDate': '2019-02-08', 'studyFirstSubmitQcDate': '2019-03-14', 'lastUpdatePostDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NRS', 'timeFrame': 'Postoperatively at 1 hour', 'description': 'Pain on a 0-10 scale where 0=no pain and 10=unbearable pain'}, {'measure': 'The incidence ipsilateral hemidiaphragmatic paralysis after 30 minutes', 'timeFrame': '30 minutes after the blocks', 'description': 'Hemidiaphragmatic paralysis was defined as the absence of diaphragmatic motion during normal respiration, coupled with absent or (paradoxical) cranial diaphragmatic movement when the patient forcefully sniffed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder Disease']}, 'descriptionModule': {'briefSummary': 'The combination of a modified lateral sagittal infraclavicular block and a suprascapular nerve block has not been studied in a cohort of total arthroplasty patients. Such diaphragm-sparing nerve blocks for shoulder arthroplasty may provide a very good anesthetic alternative in lung diseased patients who are in need for total arthroplasty of the shoulder.', 'detailedDescription': 'The investigators hypothesized that a combination of suprascapular nerve block and lateral sagittal infraclavicular block of the posterior and lateral cords would provide good postoperative analgesia for patients undergoing shoulder arthroplasty.\n\nThe primary aims of this study were to document numeric rating scale (NRS, 0-10) and use of morphine equivalents during the first 24 hours after surgery. Secondary aims were to determine the incidence of diaphragm paresis 30 minutes after the block and to quantify postoperative hand grip force at 1 hr.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-78 years old,\n* BMI 20-35 kg.m-2\n* ASA physical status 1-3\n\nExclusion Criteria:\n\n* unable to consent,\n* pregnancy,\n* pre-existing severe respiratory disease,\n* use of anticoagulation drugs other than acetylsalicylic acid or dipyridamol,\n* allergy to local anaesthetics,\n* patients on regular opioids,\n* atrioventricular block,\n* peripheral neuropathy.'}, 'identificationModule': {'nctId': 'NCT03877835', 'briefTitle': 'Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of North Norway'}, 'officialTitle': 'Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty: an Exploratory Feasibility Study', 'orgStudyIdInfo': {'id': 'REK 2018/1934-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Ropivacaine', 'description': 'SSNB will be performed with 4 ml ropivacaine 5 mg/ml LSIB will be performed With 15 ml ropivacaine 7.5 mg/ml', 'interventionNames': ['Procedure: Peripheral nerve blocks']}], 'interventions': [{'name': 'Peripheral nerve blocks', 'type': 'PROCEDURE', 'description': 'LSIB + SSNB', 'armGroupLabels': ['Ropivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9038', 'city': 'Tromsø', 'state': 'Troms', 'country': 'Norway', 'facility': 'University Hospital of North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nordlandssykehuset Bodo', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}