Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-27 @ 5:30 AM
Study NCT ID:
NCT05495750
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2022-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Suprazygomatic Maxillary Nerve Block Effect on Systemic Inflammatory Response in Cleft Palate Surgeries
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2022-08-09', 'studyFirstSubmitQcDate': '2022-08-09', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interleukin 6 serum level.', 'timeFrame': '3-5 hours', 'description': 'Two blood samples will be withdrawn in both groups, the first sample immediately after induction of general anaesthesia, endotracheal tube insertion and the other sample will be withdrawn after completion of surgery and before recovery of the patient'}], 'secondaryOutcomes': [{'measure': 'Serum Cortisol level', 'timeFrame': '3-5 hours', 'description': 'Two blood samples will be withdrawn in the both groups, the first sample immediately after induction of general anaesthesia, endotracheal tube insertion and the other sample will be withdrawn after completion of surgery and before recovery of the patient'}, {'measure': 'Plasma glucose level', 'timeFrame': '3-5 hours', 'description': 'Two blood samples will be withdrawn in the both groups, the first sample immediately after induction of general anaesthesia, endotracheal tube insertion and the other sample will be withdrawn after completion of surgery and before recovery of the patient'}, {'measure': 'C-Reactive protein (CRP)', 'timeFrame': '3-5 hours', 'description': 'Two blood samples will be withdrawn in the both groups, the first sample immediately after induction of general anaesthesia, endotracheal tube insertion and the other sample will be withdrawn after completion of surgery and before recovery of the patient'}, {'measure': 'Total leucocytic count', 'timeFrame': '3-5 hours', 'description': 'Two blood samples will be withdrawn in the both groups, the first sample immediately after induction of general anaesthesia, endotracheal tube insertion and the other sample will be withdrawn after completion of surgery and before recovery of the patient'}, {'measure': 'CHIPPS score', 'timeFrame': '1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h postoperatively.', 'description': 'Score 0 , Score 1 , Score 2'}, {'measure': 'The number of rescue analgesia doses postoperatively', 'timeFrame': '12 hours postoperative', 'description': 'IM Diclofenac(0.5 mg/kg) will be given as rescue analgesia for patients if CHIPPS was \\> 3/10'}, {'measure': 'time needed till the need of first dose recorded of rescue analgesia', 'timeFrame': '12 hours post operative', 'description': 'IM Diclofenac(0.5 mg/kg) will be given as rescue analgesia for patients if CHIPPS was \\> 3/10'}, {'measure': 'Time needed to start oral feeding will be recorded', 'timeFrame': '12 hours postoperative', 'description': 'time of starting oral feeding'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perioperative Inflammatory Response', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'the aim is to determine the value of adding bilateral supra zygomatic maxillary nerve block to general anesthesia in attenuating the systemic inflammatory response in paediatrics.', 'detailedDescription': 'Cleft lip and palate are some of the most common craniofacial malformations, with an incidence ranging between 0.1 and 1.1 per 1000 births. Early surgical intervention for cleft palate (CP) repair is essential for proper feeding and phonation as well as reduction of complications such as frequent sinusitis and other respiratory tract infections.\n\nSurgical injury stimulates the systemic inflammatory response. The neuroendocrine response leads to stimulation of the sympathetic nervous system resulting in tachycardia, hypertension and activation of the hypothalamic-pituitary adrenal axis. This induces the release of hormones such as adrenocorticotropic hormone (ACTH), catechol-amines (norepinephrine and epinephrine) and cortisol and increase in white cell count which is proposed to have a detrimental effect on the postoperative immunity. Furthermore, the production of pro-inflammatory cytokines including interleukins (IL) e.g.IL-1, IL-6, IL-8 and tumour necrosis factor alpha (TNF-α) by innate immune cells such as neutrophils and macrophages, interacting with damaged cells and platelets, leads to the production of acute phase proteins from the liver such as C-reactive protein (CRP), fibrinogen and complement proteins.\n\nRegional blocks provide good pre-emptive analgesia when given in combination with general anaesthesia (GA). It is associated with hemodynamic stability, rapid recovery, reduction of supplemental analgesia consumption in addition to favourable effect on systematic inflammatory response. Using bilateral suprazygomatic approach of maxillary nerve block during CP repair is hypothesized to provide such mentioned settlement of a regional block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary and secondary cleft palate Surgeries.\n* American Society of Anesthesiologists physical status (ASA) I to II patients.\n* Age group: 1-5 years old.\n\nExclusion Criteria:\n\n* Presence of coagulation disorders.\n* Peripheral neuropathy.\n* Local infection or lesion in puncture site.\n* Allergy to local Anesthetics.\n* Physical status: ASA III or above.'}, 'identificationModule': {'nctId': 'NCT05495750', 'briefTitle': 'Suprazygomatic Maxillary Nerve Block Effect on Systemic Inflammatory Response in Cleft Palate Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Impact of Adding Ultrasound Guided Bilateral Suprazygomatic Maxillary Nerve Block to General Anesthesia on Systemic Inflammatory Response in Cleft Palate Surgeries ; A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'FMASU MD 141/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Maxillary block group', 'description': 'The ultrasound probe will be placed in the infra zygomatic area, with an inclination of 45 degrees in the transverse plane. A 27-gauge 38-mm needle will be used for the injection. The needle will be inserted perpendicular to the skin at the frontozygomatic angle and advanced to the greater wing of the sphenoid. The needle will be then redirected and advanced to the pterygopalatine fossa.\n\nLoss of resistance after passing through the temporalis muscle will assist in determining the puncture depth, and real-time ultrasound guidance will allow seeing the spread of local anesthetic in the pterygopalatine fossa.', 'interventionNames': ['Drug: Bupivacaine 0.25% Injectable Solution']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients will receive only general anesthesia with regulated doses of IV opioids.'}], 'interventions': [{'name': 'Bupivacaine 0.25% Injectable Solution', 'type': 'DRUG', 'otherNames': ['supra zygomatic maxillary nerve block'], 'description': 'ultrasound-guided bilateral suprazygomatic maxillary nerve block using 0.15 ml/kg.', 'armGroupLabels': ['Maxillary block group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of dentisry Ainshams univeristy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Sherif S Sultan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ainshams University'}, {'name': 'Tamer N Ibrahim AbdelRahman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ainshams Univeristy'}, {'name': 'Sohib M Galal, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ainshams Univeristy'}, {'name': 'Sarah A Salem, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ainshams Univeristy'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '6 months after publication', 'ipdSharing': 'YES', 'description': 'Summary results', 'accessCriteria': 'Internet search by keywords'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alaa Mohamed Abdel Salam Ibrahim Soliman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Alaa Mohamed Abdel Salam Ibrahim Soliman', 'investigatorAffiliation': 'Ain Shams University'}}}}