Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-31 @ 10:27 PM
Study NCT ID:
NCT04925505
Status:
COMPLETED
Last Update Posted:
2025-01-03
First Post:
2021-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perfusion Index for Predicting Brachial Plexus Block Success Under General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-02', 'studyFirstSubmitDate': '2021-06-02', 'studyFirstSubmitQcDate': '2021-06-07', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perfusion Index', 'timeFrame': 'change between before and 15 minutes after brachial plexus block', 'description': 'perfusion index measured applied to both blocked and non-blocked limbs using two separate oximeters'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'change between before and 5 minutes after incision of surgical procedure', 'description': 'heart rate in bpm during operation'}, {'measure': 'Blood pressure', 'timeFrame': 'change between before and 5 minutes after incision of surgical procedure', 'description': 'blood pressure in mmHg during operation'}, {'measure': 'Pain score', 'timeFrame': '1 hour after surgery', 'description': 'Numeric rating scale for pain on a 0-10 scale where 0=no pain and 10=unbearable pain'}, {'measure': 'Sensory function test on supraclavicular nerve and axillary nerve', 'timeFrame': '1 hour after surgery', 'description': '0-2 scale where 0=no block; 1=analgesia (patient can feel touch, not cold); 2=anesthesia (patient cannot feel touch)'}, {'measure': 'Motor function test on supraclavicular nerve and axillary nerve and', 'timeFrame': '1 hour after surgery', 'description': '0-2 scale where 0 = no block; 1 = paresis; 2 = paralysis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Disorder of Shoulder']}, 'referencesModule': {'references': [{'pmid': '28854539', 'type': 'BACKGROUND', 'citation': 'Abdelnasser A, Abdelhamid B, Elsonbaty A, Hasanin A, Rady A. Predicting successful supraclavicular brachial plexus block using pulse oximeter perfusion index. Br J Anaesth. 2017 Aug 1;119(2):276-280. doi: 10.1093/bja/aex166.'}, {'pmid': '20708419', 'type': 'BACKGROUND', 'citation': 'Misamore G, Webb B, McMurray S, Sallay P. A prospective analysis of interscalene brachial plexus blocks performed under general anesthesia. J Shoulder Elbow Surg. 2011 Mar;20(2):308-14. doi: 10.1016/j.jse.2010.04.043. Epub 2010 Aug 13.'}, {'pmid': '28696947', 'type': 'BACKGROUND', 'citation': 'Marhofer P. Regional blocks carried out during general anesthesia or deep sedation: myths and facts. Curr Opin Anaesthesiol. 2017 Oct;30(5):621-626. doi: 10.1097/ACO.0000000000000504.'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to determine whether the success or failure of interscalene brachial plexus block under general anesthesia can be predicted using perfusion index (PI).', 'detailedDescription': 'The success of peripheral nerve blocks is usually evaluated by assessment of sensory and motor function; however, this method cannot be applied in the patient who has uncheckable mental status, e.g. general anesthesia, or who is uncommunicable, e.g. different language user.\n\nThe perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter, and PI had been proved as a useful tool for evaluation of successful supraclavicular nerve block in awake patients as an objective method.\n\nWith the use of ultrasound guidance in skilled hands, it is a reasonable option to perform neuraxial and peripheral regional blocks in sedated or anesthetized patients. However, there has been no evidence of applying PI for predicting the success of nerve block in general anesthetized patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients aged 20-70 who are scheduled for shoulder surgery under general anesthesia, with ASA physical status I-III', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20-70 years old,\n* BMI 20-35 kg.m-2,\n* elective shoulder surgery,\n* ASA physical status I-III\n\nExclusion Criteria:\n\n* refusal of the patient,\n* comorbid with serious vascular disease,\n* diabetes,\n* allergy to local anesthetics,\n* patients on regular opioids,\n* peripheral neuropathy.'}, 'identificationModule': {'nctId': 'NCT04925505', 'briefTitle': 'Perfusion Index for Predicting Brachial Plexus Block Success Under General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Guro Hospital'}, 'officialTitle': 'Usefulness of Pulse Oximeter Perfusion Index for Predicting the Success of Interscalene Brachial Plexus Blockade Under General Anesthesia', 'orgStudyIdInfo': {'id': '2021GR0104'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BPB success', 'description': 'The study included patients aged between 20 and 70 yr who are to undergo elective shoulder surgery under general anesthesia. Patients undergo general anesthesia induction before the interscalene block is performed. Ultrasound-guided interscalene brachial plexus block will be performed in anesthetized patients before surgery. PI monitor will be applied to both blocked and non-blocked limbs using two separate oximeters. And the SUCCESS (or failure) of the block will be confirmed by (1) 30% change of heart rate and blood pressure after incision during operation, and (2) pain score, motor and sensory function test after surgery in the post-anesthesia recovery unit.', 'interventionNames': ['Procedure: Interscalene brachial plexus blocks with ultrasound guidance under general anesthesia']}, {'label': 'BPB failure', 'description': 'The study included patients aged between 20 and 70 yr who are to undergo elective shoulder surgery under general anesthesia. Patients undergo general anesthesia induction before the interscalene block is performed. Ultrasound-guided interscalene brachial plexus block will be performed in anesthetized patients before surgery. PI monitor will be applied to both blocked and non-blocked limbs using two separate oximeters. And the (success or) FAILURE of the block will be confirmed by (1) 30% change of heart rate and blood pressure after incision during operation, and (2) pain score, motor and sensory function test after surgery in the post-anesthesia recovery unit.', 'interventionNames': ['Procedure: Interscalene brachial plexus blocks with ultrasound guidance under general anesthesia']}], 'interventions': [{'name': 'Interscalene brachial plexus blocks with ultrasound guidance under general anesthesia', 'type': 'PROCEDURE', 'description': 'Ultrasound-guidance, interscalene brachial plexus blocks, in-plane technique, perineural injection, 0.5% ropivacaine 12.5ml and 0.2% lidocaine 12.5ml', 'armGroupLabels': ['BPB failure', 'BPB success']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08308', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anaesthesiology and Pain Medicine, Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Guro Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Seok Kyeong Oh', 'investigatorAffiliation': 'Korea University Guro Hospital'}}}}