Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT05580094
Status:
COMPLETED
Last Update Posted:
2024-11-12
First Post:
2022-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Supraclavicular Block and General Anesthesia in Pediatric Patients With Chronic Kidney Disease
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': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double (Participant, Outcomes Assessor)'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double-blinded controlled trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-08', 'studyFirstSubmitDate': '2022-10-06', 'studyFirstSubmitQcDate': '2022-10-12', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'brachiocephalic fistula maturation time', 'timeFrame': '6 month postoperative', 'description': 'time in weeks required by fistula to be clinically mature'}], 'secondaryOutcomes': [{'measure': 'anaesthetic consumption', 'timeFrame': '90 minutes intraoperative', 'description': 'measurment of anesthesia MAC'}, {'measure': 'postoperative analgesia time', 'timeFrame': '24 hours postoperative'}, {'measure': 'EMERGENCE agitation', 'timeFrame': '30 minutes postoperative', 'description': 'RASS score used with -5 = deeply sedated and 4 = highly agitated'}, {'measure': 'VAS score', 'timeFrame': '24h postoperative', 'description': 'scale of 10 points. zero= no pain and 10 = worest pain'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Operative Pain']}, 'referencesModule': {'references': [{'pmid': '26171895', 'type': 'BACKGROUND', 'citation': 'Manyande A, Cyna AM, Yip P, Chooi C, Middleton P. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD006447. doi: 10.1002/14651858.CD006447.pub3.'}, {'pmid': '24907283', 'type': 'BACKGROUND', 'citation': 'Suresh S, Schaldenbrand K, Wallis B, De Oliveira GS Jr. Regional anaesthesia to improve pain outcomes in paediatric surgical patients: a qualitative systematic review of randomized controlled trials. Br J Anaesth. 2014 Sep;113(3):375-90. doi: 10.1093/bja/aeu156. Epub 2014 Jun 6.'}, {'pmid': '18544144', 'type': 'BACKGROUND', 'citation': 'De Jose Maria B, Banus E, Navarro Egea M, Serrano S, Perello M, Mabrok M. Ultrasound-guided supraclavicular vs infraclavicular brachial plexus blocks in children. Paediatr Anaesth. 2008 Sep;18(9):838-44. doi: 10.1111/j.1460-9592.2008.02644.x. Epub 2008 Jun 9.'}, {'pmid': '40380096', 'type': 'DERIVED', 'citation': 'Elsawy S, Fathy E, Elbadawy A, Elnaggar A, Abdelatif AF, Elmorabaa H, Hamed R. Ultrasound-guided supraclavicular brachial plexus block as an additive to sevoflurane anesthesia in pediatrics undergoing brachiobasilic arteriovenous fistula operation: randomized controlled clinical trial. BMC Anesthesiol. 2025 May 16;25(1):248. doi: 10.1186/s12871-025-03091-1.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1093/bjaceaccp/mku064', 'label': 'Anaesthesia for children with renal disease.'}]}, 'descriptionModule': {'briefSummary': '* compare the safety and efficacy of ultrasound-guided supraclavicular block in addition to general anesthesia in pediatric patients undergoing upper limb superficialization of arteriovenous fistula for hemodialysis.\n* compare the amount of analgesic consumption as well as vasodilatation of upper limb blood vessels and its implications on the vascular anastomosis.', 'detailedDescription': 'Established renal disease is a significant cause of morbidity and mortality in children and has implications for the conduct of general anesthesia (1).\n\nAnesthetic management of pediatric patients is uniquely challenging. A large part of the anesthetic care includes pain management, management of concomitant disease, and risk reduction for adverse events. Perioperative pain management usually involves a multimodal pharmacologic approach to minimize opioid requirements. Regional anesthesia is valuable for postoperative pain control (2).\n\nPostoperative analgesia is dictated by the extent and nature of the surgery. Regional block should be utilized where possible for its opioid-sparing effects. Where morphine infusions are commenced, the dose should be reduced due to the risk of accumulation of active metabolites and resultant opiate toxicity. Non-steroidal anti-inflammatory drugs are always avoided due to their deleterious effects on urine output (3).\n\nPediatric regional anesthesia is one of the most valuable and safe tools to treat perioperative pain and is an essential part of modern anesthetic practice. It provides excellent pain relief and allows caregivers to use multimodal analgesic techniques and decrease the use of opioids. Upper extremity brachial plexus blocks in children Various approaches to brachial plexus are available. The choice of the block is made depending on the indications. The supra-clavicular approach covers all the surgeries of the humerus and below (4).\n\nThe use of regional anaesthesia is mostly associated with vasodilatation which may guard against arterial spasm and may play a role in decreasing the postoperative complication and success of the superficialization of the arteriovenous shunt as a line for hemodialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients of less than 18 years old.\n* with chronic kidney disease.\n* undergoing upper limb superficialization of arteriovenous fistula for haemodialysis.\n\nExclusion Criteria:\n\n* Patient known to have allergy to the studied drugs.\n* Patients with contraindications to regional anesthesia.'}, 'identificationModule': {'nctId': 'NCT05580094', 'briefTitle': 'Combined Supraclavicular Block and General Anesthesia in Pediatric Patients With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Combined General Anesthesia and Ultrasound Guided Supraclavicular Block Versus General Anesthesia in Pediatric Patients With Chronic Kidney Disease Undergoing Upper Limb Superficialization of Arteriovenous Fistula.', 'orgStudyIdInfo': {'id': 'supraclavicular block and GA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'General anesthesia only.', 'description': 'the pediatric patients will receive general anesthesia only.', 'interventionNames': ['Other: general anesthesia only.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'General anesthesia plus supraclavicular block.', 'description': 'the pediatric patients will receive combined supraclavicular block and general anesthesia.', 'interventionNames': ['Other: general anesthesia plus supraclavicular block.']}], 'interventions': [{'name': 'general anesthesia only.', 'type': 'OTHER', 'description': 'induction of general anesthesia by propofol and maintenance sevoflurane.', 'armGroupLabels': ['General anesthesia only.']}, {'name': 'general anesthesia plus supraclavicular block.', 'type': 'OTHER', 'description': 'induction of general anesthesia by propofol and maintenance sevoflurane then the patients will receive the supraclavicular block with bupivacaine 0.5 ml per kg.', 'armGroupLabels': ['General anesthesia plus supraclavicular block.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Egypt', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor at anesthesia,icu and pain management department', 'investigatorFullName': 'Esraa Fathy Radwan Abd Elzaher', 'investigatorAffiliation': 'Assiut University'}}}}