Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-31 @ 12:08 AM
Study NCT ID:
NCT04444635
Status:
COMPLETED
Last Update Posted:
2021-06-25
First Post:
2020-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serratus Anterior Plane Block in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Blindness will be achieved by patient codes which will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A physician not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anaesthesiologist who is expert in doing the serratus anterior plane block in patients included within the block group. This expert anaesthesiologist will not be involved in collecting data but another anaesthesia doctor will be responsible for patient management and collecting the intraoperative and postoperative data.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-23', 'studyFirstSubmitDate': '2020-06-20', 'studyFirstSubmitQcDate': '2020-06-22', 'lastUpdatePostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The total dose of postoperative operative fentanyl consumption in the first 24 hours.', 'timeFrame': '12 months', 'description': 'The total dose of postoperative operative fentanyl consumption in micrograms in the first 24 hours will be calculated'}], 'secondaryOutcomes': [{'measure': 'Total dosage of additional fentanyl boluses usage in micrograms intraoperatively', 'timeFrame': '12 months', 'description': 'Total dosage of additional fentanyl boluses usage in micrograms intraoperatively'}, {'measure': 'First rescue analgesia', 'timeFrame': '12 months', 'description': 'Time (in minutes) to 1st rescue analgesia (morphine) post operatively which will be defined to be the elapsed time between stoppage of fentanyl infusion and a patient FLACC score equal or more than 4.'}, {'measure': 'Pain assessment postoperatively by Face, Leg, Activity, Cry, Consolability (FLACC) score, minimum is zero, and maximum is 6.', 'timeFrame': '12 months', 'description': 'Pain assessment at 30 min, 60 min, 2 hours, 4hours, 8hours postoperatively by FLACC score.'}, {'measure': 'Intra and postoperative heart rate.', 'timeFrame': '12 months', 'description': 'Intra and postoperative heart rate.'}, {'measure': 'Intraoperative and postoperative systolic blood pressure.', 'timeFrame': '12 months', 'description': 'Intraoperative and postoperative systolic blood pressure.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Serratus anterior plane block', 'Pediatric', 'Thoracotomy'], 'conditions': ['Anesthesia, Local']}, 'referencesModule': {'references': [{'pmid': '15668207', 'type': 'BACKGROUND', 'citation': 'Lonnqvist PA, Morton NS. Postoperative analgesia in infants and children. Br J Anaesth. 2005 Jul;95(1):59-68. doi: 10.1093/bja/aei065. Epub 2005 Jan 21. No abstract available.'}, {'pmid': '11772793', 'type': 'BACKGROUND', 'citation': 'Senturk M, Ozcan PE, Talu GK, Kiyan E, Camci E, Ozyalcin S, Dilege S, Pembeci K. The effects of three different analgesia techniques on long-term postthoracotomy pain. Anesth Analg. 2002 Jan;94(1):11-5, table of contents. doi: 10.1213/00000539-200201000-00003.'}, {'pmid': '11020770', 'type': 'BACKGROUND', 'citation': 'Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.'}, {'pmid': '11825739', 'type': 'BACKGROUND', 'citation': 'Rogers ML, Henderson L, Mahajan RP, Duffy JP. Preliminary findings in the neurophysiological assessment of intercostal nerve injury during thoracotomy. Eur J Cardiothorac Surg. 2002 Feb;21(2):298-301. doi: 10.1016/s1010-7940(01)01104-6.'}, {'pmid': '23923989', 'type': 'RESULT', 'citation': 'Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this work is to study the efficacy of ultrasound guided serratus anterior plane block in pediatric patients undergoing thoracic surgeries.\n\nIt is a randomized controlled trial.', 'detailedDescription': 'It is a prospective randomized controlled study. It is designed to estimate and compare the analgesic effect of single shot serratus anterior plane block in pediatric patients undergoing thoracic surgeries with fentanyl infusion versus fentanyl infusion alone as the control group. Our primary outcome will be the total dose of intra-operative fentanyl boluses.\n\nRandomization will be achieved by using an online random number generator. Blindness will be achieved by patient codes which will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A physician not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anaesthesiologist who is expert in doing the serratus anterior plane block in patients included within the block group. This expert anaesthesiologist will not be involved in collecting data but another anaesthesia doctor will be responsible for patient management and collecting the intraoperative and postoperative data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 6 months-3 years.\n* American Society of anesthesiology (ASA) I and II.\n* Pediatric patients undergoing thoracic surgeries (with anterior thoracotomy incision).\n\nExclusion Criteria:\n\n* Patients whose parents or legal guardians refusing to participate.\n* Preoperative mechanical ventilation.\n* Known or suspected coagulopathy.\n* Infection at the site of injection.\n* Known or suspected allergy to any of the studied drugs.\n* Elevated liver enzymes more than the normal values.\n* Procedures with anticipated significant hemodynamic stability.\n* Renal function impairment (Creatinine value more than 1.2mg/dl or blood urea nitrogen (BUN) more than 20mg/dl).'}, 'identificationModule': {'nctId': 'NCT04444635', 'briefTitle': 'Serratus Anterior Plane Block in Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Serratus Anterior Plane Block in Pediatric Patients Undergoing Thoracic Surgeries: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'N110-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Serratus Anterior Plan block plus fentanyl infusion', 'description': 'The patients will receive serratus anterior block in addition to continous intraoperative fentanyl infusion.', 'interventionNames': ['Procedure: Serratus Anterior Plan Block+ Fentanyl infusion', 'Drug: Fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fentanyl infusion only', 'description': 'The patient will receive fentanyl infusion only.', 'interventionNames': ['Drug: Fentanyl']}], 'interventions': [{'name': 'Serratus Anterior Plan Block+ Fentanyl infusion', 'type': 'PROCEDURE', 'otherNames': ['Serratus Anterior Plan Block'], 'description': 'After induction of anesthesia, the patients will be put on the lateral position with the diseased side up. A linear ultrasound transducer will be placed in a sagittal plane over the mid-clavicular region of the thoracic cage.\n\nThen counting down ribs till the fifth rib will be identified in the mid-axillary line. The following muscles will be identified overlying the fifth rib: the latissimus dorsi (superficial and posterior),teres major (superior) and serratus muscles (deep and inferior). Under complete sterile conditions, the needle (25 G needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus anterior muscle. Then, 2 mg/kg of 0.25% bupivacaine will be injected with continuous ultrasound guidance. In addition to continuous fentanyl infusion', 'armGroupLabels': ['Serratus Anterior Plan block plus fentanyl infusion']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'Continuous fentanyl infusion throughout the surgical procedure.', 'armGroupLabels': ['Fentanyl infusion only', 'Serratus Anterior Plan block plus fentanyl infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'AHMED ISMAIL, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The patients data are confidential'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Ahmed Abdelaziz Ismail', 'investigatorAffiliation': 'Cairo University'}}}}