Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-30 @ 3:55 PM
Study NCT ID:
NCT02266732
Status:
COMPLETED
Last Update Posted:
2015-02-23
First Post:
2014-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Vs Nerve Stimulation - Why is a PNS so Effective?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059352', 'term': 'Musculoskeletal Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-19', 'studyFirstSubmitDate': '2014-10-03', 'studyFirstSubmitQcDate': '2014-10-16', 'lastUpdatePostDateStruct': {'date': '2015-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nerve stimulation resulting in muscle contraction or not', 'timeFrame': 'Five minutes', 'description': 'Whether the nerve is successfully stimulated, resulting in muscle contraction, or not when the needle is on the wrong side of the fascial layer.'}]}, 'conditionsModule': {'conditions': ['Musculoskeletal Pain']}, 'descriptionModule': {'briefSummary': 'The traditional model of localizing a nerve for blockade is using a peripheral nerve stimulator, PNS. Recent advances in UltraSound technology has allowed UltraSound to guide nerve blockade. However despite excellent visualization nerve block success has not significantly improved. I aim to show that this is because the PNS stimulation of a nerve is more than a proximity response as thought but a correct fascial plane response and hence the high success rate of this blind approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1 to 3 patients for any shoulder surgery or unilateral ACL knee surgery\n\nExclusion Criteria:\n\n* Refusal to consent\n* Allergy to Chirocaine local anaesthetic\n* Pace maker in situ\n* Sepsis at site of regional block'}, 'identificationModule': {'nctId': 'NCT02266732', 'briefTitle': 'Ultrasound Vs Nerve Stimulation - Why is a PNS so Effective?', 'organization': {'class': 'OTHER', 'fullName': 'The Leeds Teaching Hospitals NHS Trust'}, 'officialTitle': 'Ultrasound Vs Nerve Stimulation - Why is a PNS so Effective?', 'orgStudyIdInfo': {'id': 'AN11/9771'}, 'secondaryIdInfos': [{'id': '11/YH/0206', 'type': 'OTHER', 'domain': 'Research Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Interscalene block', 'interventionNames': ['Device: Stimuplex HNS 12']}, {'type': 'OTHER', 'label': 'Femoral block', 'interventionNames': ['Device: Stimuplex HNS 12']}], 'interventions': [{'name': 'Stimuplex HNS 12', 'type': 'DEVICE', 'otherNames': ['Peripheral nerve stimulator for nerve location'], 'armGroupLabels': ['Femoral block', 'Interscalene block']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Leeds Teaching Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}