Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:57 PM
Study NCT ID:
NCT04786756
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2021-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Lateral and Medial Approaches to Costoclavicular Brachial Plexus Block in Pediatrics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'RANDOMISED DOUBLE BLINDED INTERVENTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-10', 'studyFirstSubmitDate': '2021-03-05', 'studyFirstSubmitQcDate': '2021-03-05', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of needle maneuvers', 'timeFrame': 'Up to 15 minutes', 'description': 'Number of needle maneuvers according to local anesthetic distribution'}], 'secondaryOutcomes': [{'measure': 'Ideal USG guided brachial plexus cords visualization/needle pathway planning time', 'timeFrame': 'Up to 15 minutes', 'description': "Practitioner's ideal image acquisition time"}, {'measure': 'Needle tip and shaft imaging visualization', 'timeFrame': 'Up to 15 minutes', 'description': 'Likert scale: 1-5'}, {'measure': 'Requirement of additional needle maneuver due to insufficient local anesthetic distribution', 'timeFrame': 'Up to 15 minutes', 'description': 'Extra needle redirection to cover neural tissue'}, {'measure': 'Total procedure difficulty according to the anesthesiologist', 'timeFrame': 'Up to 15 minutes', 'description': 'Likert Scale 1-5 (1:very hard 5:very easy)'}, {'measure': 'Patient number requiring rescue analgesics', 'timeFrame': 'Intraoperative 2-4 hours', 'description': 'If a ≥ 20% increase above preinduction values in MAP or HR was observed during the perioperative period, additional fentanyl dose (1 μg/kg) was applied intravenously.'}, {'measure': 'Face, Legs Activity, Cry, Consolability (FLACC) scores', 'timeFrame': 'Up to 24 hours', 'description': 'It corporates five categories of behavior, each scored on 0-2 point scale so that total score ranges from 0 to 10. Total scores of 0-3 is defined as mild or no pain, 4-7 as moderate, and 8-10 as severe pain.'}, {'measure': 'Wong Baker FACES scale', 'timeFrame': 'Up to 24 hours', 'description': 'The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable"'}, {'measure': 'Motor blockade physical examination', 'timeFrame': 'Up to 24 hours', 'description': 'Each nerve scored on 0-2 point scale so that total score ranges from 0 to 8. Total scores of 0 point is defined as absent motor blockade (full movement); 1 point as partial blockade (able to free movement only) or 2 point as complete blockade (unable to move). (Separately for these four nerves; N. Medianus, N. ulnaris, N. radialis and N. musculocutaneous).'}, {'measure': 'Sensorial blockade physical examination', 'timeFrame': 'Up to 24 hours', 'description': 'Each nerve scored on 0-2 point scale with pinprick test so that total score ranges from 0 to 8. Total scores of 0 point is defined as absent sensorial blockade (feels pain), 1 point as partial blockade (feels touch) or 2 point as complete blockade (no sense). (Separately for these four nerves; N. Medianus, N. ulnaris, N. radialis and N. musculocutaneous).'}, {'measure': 'Time to first pain', 'timeFrame': 'Up to 24 hours', 'description': 'Time to first analgesic'}, {'measure': 'Patient number requiring additional analgesix', 'timeFrame': 'Up to 24 hours', 'description': 'Number of patients who require IV morphine (0.03 mg/kg) and paracetamol (15 mg/kg)'}, {'measure': 'Sleeping duration', 'timeFrame': 'Up to 24 hours', 'description': 'Total hours of sleep first day'}, {'measure': 'Complications/side effects', 'timeFrame': 'Up to 24 hours', 'description': 'Possible complications related to costoclavicular block (such as vascular puncture, hematoma, pneumothorax, diaphragma palsy...)'}, {'measure': 'Family satisfaction', 'timeFrame': 'Up to 24 hours', 'description': 'Satisfaction score: 0: very unsatisfied 3: very satisfied'}, {'measure': 'Surgeon satisfaction', 'timeFrame': 'Up to 24 hours', 'description': 'Satisfaction score: 0: very unsatisfied, 3: very satisfied'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative Analgesia', 'Upper Extremity Surgery', 'Costoclavicular Block', 'Brachial Plexus Block', 'Ultrasound Guidance'], 'conditions': ['Anesthesia, Local', 'Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '29923950', 'type': 'BACKGROUND', 'citation': 'Songthamwat B, Karmakar MK, Li JW, Samy W, Mok LYH. Ultrasound-Guided Infraclavicular Brachial Plexus Block: Prospective Randomized Comparison of the Lateral Sagittal and Costoclavicular Approach. Reg Anesth Pain Med. 2018 Nov;43(8):825-831. doi: 10.1097/AAP.0000000000000822.'}]}, 'descriptionModule': {'briefSummary': 'In upper extremity surgeries, the brachial plexus block can be performed with different techniques at various levels depending on the proximal and distal level of the surgery. In this study, we aim to compare the different approaches of US guided costoclavicular technique. Lateral approache is more common for the costoclavicular block area. However, more needle maneuvers are needed especially in pediatric patients because of the coracoid process. Medial approach is recommended to overcome this problem. Thus demonstrate the safety of upper extremity blocks, which is an important part of multimodal analgesia, and to determine the most ideal technique in the pediatric patient group who will undergo upper extremity surgery.\n\nDuring the block application, the US imaging time, the difficulty level of needle imaging, the number of maneuvers required to reach the target image, whether additional maneuvers are required according to the local anesthetic distribution, the success of the block and the duration of the surgery, the total application time of the block and the duration of general anesthesia will be recorded. Mean arterial pressure and heart rate will be recorded at 30-minute intervals during the surgery. Standardized for pediatric patients The FLACC and Wong-Baker pain scores will be followed first 24 hours after surgery. The patient will be examined for motor and sensation, and analgesic doses will be recorded if used. Time to first pain identification, duration of sleep, patient and surgeon satisfaction will be recorded.', 'detailedDescription': 'Peripheral nerve blocks; It is widely used in daily practice for anesthesia or as a part of multimodal analgesia in most surgical procedures. In upper extremity surgeries, the brachial plexus block can be performed with different techniques at various levels depending on the proximal and distal level of the surgery. In this study, the aim is to compare postoperative analgesic effects of these two ultrasound-guided techniques in pediatric patients. In this study, we aim to compare the different approaches of US guided costoclavicular technique. Lateral approache is more common for the costoclavicular block area. However, more needle maneuvers are needed especially in pediatric patients because of the coracoid process. Medial approach is recommended to overcome this problem. Thus demonstrate the safety of upper extremity blocks, which is an important part of multimodal analgesia, and to determine the most ideal technique in the pediatric patient group who will undergo upper extremity surgery.\n\nDuring the block application, the US imaging time, the difficulty level of needle imaging, the number of maneuvers required to reach the target image, whether additional maneuvers are required according to the local anesthetic distribution, the success of the block and the duration of the surgery, the total application time of the block and the duration of general anesthesia will be recorded. Mean arterial pressure and heart rate will be recorded at 30-minute intervals during the surgery. Standardized for pediatric patients The FLACC and Wong-Baker pain scores will be followed first 24 hours after surgery. The patient will be examined for motor and sensation, and analgesic doses will be recorded if used. Time to first pain identification, duration of sleep, patient and surgeon satisfaction will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing unilateral upper extremity surgery (distal midhumerus).\n* ASA(American Society of Anesthesiology) 1-3\n* Receiving family consent from the parents that they accept regional analgesia\n\nExclusion Criteria:\n\n\\- Parents refusal\n\n* Infection on the local anesthetic application area\n* Infection in the central nervous system\n* Coagulopathy\n* Brain tumors\n* Known allergy against local anesthetics\n* Anatomical difficulties\n* Syndromic patient'}, 'identificationModule': {'nctId': 'NCT04786756', 'briefTitle': 'Comparison of Lateral and Medial Approaches to Costoclavicular Brachial Plexus Block in Pediatrics', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Comparison of Ultrasound-Guided Lateral and Medial Approaches to Costoclavicular Brachial Plexus Block in Pediatric Patients Undergoing Unilateral Upper Exremity Surgery: A Randomized Controlled Double-Blinded Study', 'orgStudyIdInfo': {'id': '2019/1556'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lateral Approach of Costoclavicular Block', 'description': 'US-guided lateral approach costoclavicular block with 1 mg/kg Bupivacaine (%0,25)', 'interventionNames': ['Drug: Bupivacaine 0.25% Injectable Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medial Approach of Costoclavicular Block', 'description': 'US-guided medial approach costoclavicular block with 1 mg/kg Bupivacaine (%0,25)', 'interventionNames': ['Drug: Bupivacaine 0.25% Injectable Solution']}], 'interventions': [{'name': 'Bupivacaine 0.25% Injectable Solution', 'type': 'DRUG', 'otherNames': ['Marcaine'], 'description': '1 mg/kg Bupivacaine (0.25%)', 'armGroupLabels': ['Lateral Approach of Costoclavicular Block', 'Medial Approach of Costoclavicular Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Meltem Savran Karadeniz, Assoc.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Meltem Savran Karadeniz', 'investigatorAffiliation': 'Istanbul University'}}}}