Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-28 @ 12:11 AM
Study NCT ID:
NCT05222334
Status:
UNKNOWN
Last Update Posted:
2022-02-03
First Post:
2022-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-Guided Extrafascial Versus Intrafascial Interscalene Brachial Plexus Block in Shoulder Arthroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-02', 'studyFirstSubmitDate': '2022-01-24', 'studyFirstSubmitQcDate': '2022-02-02', 'lastUpdatePostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of diaphragmatic excursion reduction after interscalene block', 'timeFrame': '30 min postoperative.', 'description': 'The diaphragmatic excursion will be measured before the procedure (pre-block), 30 min after the block, and postoperative in Post-Anesthesia Care Unit. Hemidiaphragmatic paresis is defined as hemi-diaphragmatic excursion reduction superior to 75% compared with the pre-procedure value.'}], 'secondaryOutcomes': [{'measure': 'Efficacy of block (sensory)', 'timeFrame': '30 minutes Postoperatively', 'description': 'The sensory block is assessed by pinprick on a score ranging from 2 to 0 scored as full sensation =2, decreased sensation =1, and loss of sensation to touch or pinprick=0. A successful block is defined as complete sensory (score= 0) in the distribution of the C5 and C6 nerve roots within 30 min of performing the Interscalene Brachial Plexus Block.'}, {'measure': 'Forced expiratory volume in 1 second (FEV 1)', 'timeFrame': 'Intraoperatively or 30 minutes postoperatively', 'description': 'Respiratory related outcome: pulmonary function test including forced expiratory volume in 1 second (FEV 1) will be assessed before block and 30 minutes after discharge to Post-Anesthesia Care Unit (PACU) with a laboratory spirometer (Carevusion Germany Spirometer; Master screen PFT). The best value will be measured and recorded'}, {'measure': 'Pain score using numerical rating scale (NRS)', 'timeFrame': '24 hours Postoperative', 'description': 'Numerical rating scale (NRS) for assessment of pain intensity (0 = no pain) to (10 = intolerable pain), pain relief is defined as a numerical rating scale of 3 or lower. If the score is \\>3, the patient will need analgesia in the form of morphine 0.05 mg/kg till it decreases to ≤3. numerical rating scale will be assessed and recorded on arrival to Post-Anesthesia Care Unit (PACU), 1, 2, 4, 8, 12, and 24 hr postoperatively by an anesthesiologist who is blinded to the study groups'}, {'measure': 'Total postoperative analgesic consumption', 'timeFrame': '24 hours Postoperative', 'description': 'Total consumption of rescue analgesia in form of morphine 0.05 mg/kg/ dose will be recorded'}, {'measure': 'Peak expiratory flow (PEF)', 'timeFrame': 'Intraoperatively or 30 minutes postoperatively', 'description': 'Peak expiratory flow (PEF) will be assessed before block and 30 minutes after discharge to Post-Anesthesia Care Unit (PACU) with a laboratory spirometer (Carevusion Germany Spirometer; Master screen PFT). The best value will be measured and recorded'}, {'measure': 'Efficacy of block (Motor)', 'timeFrame': '30 minutes Postoperatively', 'description': 'Motor assessment will be tested by using arm abduction (C5), and forearm flexion (C6) (incapacity to overcome gravity= 0; reduced force compared with contralateral arm =1, no loss of force =2). A successful block is defined as motor (score,=0) block in the distribution of the C5 and C6 nerve roots within 30 min of performing the Interscalene Brachial Plexus Block.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthroscopy', 'Analgesia', 'Intrafascial Interscalene Brachial Plexus Block']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the diaphragmatic excursion and postoperative analgesia in the extrafascial versus intrafascial Interscalene brachial plexus block in patients undergoing shoulder arthroscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients of both sexes aged (21-60years) with American Society of Anesthesiologists (ASA) physical status I/II scheduled for shoulder arthroscopy\n\nExclusion Criteria:\n\n1. Patient refusal.\n2. Pre-existing (obstructive or restrictive) pulmonary disease.\n3. Bleeding disorders (coagulopathy).\n4. Mental dysfunction.\n5. History of allergy to local anesthetics.\n6. Pregnancy\n7. Body mass index (BMI) \\>40'}, 'identificationModule': {'nctId': 'NCT05222334', 'briefTitle': 'Ultrasound-Guided Extrafascial Versus Intrafascial Interscalene Brachial Plexus Block in Shoulder Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Perioperative Respiratory and Analgesic Effects of Ultrasound-Guided Extrafascial Versus Intrafascial Interscalene Brachial Plexus Block in Patients Undergoing Shoulder Arthroscopy', 'orgStudyIdInfo': {'id': '33802/4/20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intrafascial interscalene brachial plexus block group', 'description': 'The patients will receive 10 ml of 0.5% bupivacaine for intrafascial interscalene brachial plexus block group', 'interventionNames': ['Procedure: Intrafascial interscalene brachial plexus block', 'Drug: Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Extrafascial interscalene brachial plexus block group', 'description': 'The patients will receive 10 ml of 0.5% bupivacaine for extrafascial interscalene brachial plexus block group', 'interventionNames': ['Procedure: Extrafascial interscalene brachial plexus block group', 'Drug: Bupivacaine']}], 'interventions': [{'name': 'Intrafascial interscalene brachial plexus block', 'type': 'PROCEDURE', 'description': 'After sterilization of skin with povidone-iodine (betadine) and skin infiltration with 1-3ml lidocaine 1%, interscalene brachial plexus block will be performed using an ultrasound machine (Phillips Cx-50,Amsterdam, Netherlands) with a linear probe (L12-3 MHz) will be used in both groups. The US transducer will be placed under aseptic fashion on the lateral side of the neck at the cricoid cartilage level to view three hypoechoic structures, that represent the roots of the brachial plexus.\n\nThe two outermost nerve roots (C5 and C6) between the anterior and the middle scalene muscles will be identified and the local anesthetic (10 ml 0.5% bupivacaine) is then injected, so that spread will be seen immediately between the C5 and the C6 nerve roots.', 'armGroupLabels': ['Intrafascial interscalene brachial plexus block group']}, {'name': 'Extrafascial interscalene brachial plexus block group', 'type': 'PROCEDURE', 'description': 'Final needle tip position will be 4 mm lateral to the brachial plexus sheath, at a level equidistant between C5 and C6 roots. The distance of 4 mm is chosen according to the calculated success rate over 90% reported. the local anesthetic (10 ml 0.5% bupivacaine) is then injected', 'armGroupLabels': ['Extrafascial interscalene brachial plexus block group']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'bupivacaine', 'armGroupLabels': ['Extrafascial interscalene brachial plexus block group', 'Intrafascial interscalene brachial plexus block group']}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'One year after the end of study', 'ipdSharing': 'YES', 'description': 'The data will be available upon any reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Radwa Emad Eissa', 'investigatorAffiliation': 'Tanta University'}}}}