Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-07 @ 4:37 AM
Study NCT ID:
NCT06725667
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2024-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-Guided Transversalis Fascia Plane Block Versus Caudal Block for Postoperative Analgesia in Children Undergoing Inguinal Herniorrhaphy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2024-12-05', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to the 1st rescue analgesia', 'timeFrame': '24 hours postoperatively', 'description': 'Time to the first request for the rescue analgesia (time from the end of surgery to first dose of paracetamol administrated).'}], 'secondaryOutcomes': [{'measure': 'Total paracetamol consumption', 'timeFrame': '24 hours postoperatively', 'description': 'Each of the five items of the Face, legs, activity, cry, and consolability (FLACC) scale will be scared, ranging from 0 to 2, which will be then aggregated to obtain a total score ranging from 0 to 10. Higher scores on the scale indicated a higher level of pain intensity. If the FLACC scale exceeds three, IV paracetamol (15 mg/kg) will be given.'}, {'measure': 'Intraoperative fentanyl consumption', 'timeFrame': 'Intraoperatively', 'description': 'Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).'}, {'measure': 'Degree of pain', 'timeFrame': '24 hours postoperatively', 'description': 'Degree of pain will be assessed using the Face, legs, activity, cry, and consolability (FLACC) scale. Each of the five items of the FLACC scale will be scared, ranging from 0 to 2, which will be then aggregated to obtain a total score ranging from 0 to 10. Higher scores on the scale indicated a higher level of pain intensity.'}, {'measure': 'Hear rate', 'timeFrame': 'Every 15 min till the end of surgery (Up to 2 hours)', 'description': 'Hear rate will be recorded preoperatively, before performing of block, and every 15 min till the end of surgery.'}, {'measure': 'Mean arterial pressure', 'timeFrame': 'Every 15 min till the end of surgery (Up to 2 hours)', 'description': 'Mean arterial pressure will be recorded preoperatively, before performing of block, and every 15 min till the end of surgery.'}, {'measure': "Degree of patient's parents satisfaction", 'timeFrame': '24 hours postoperatively', 'description': "Degree of patient's parents satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)"}, {'measure': 'Incidence of adverse events', 'timeFrame': '24 hours postoperatively', 'description': 'Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication related to block such as hematoma, neurological injury, deep visceral injury, or local anesthetic toxicity will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ultrasound', 'Transversalis Fascia Plane Block', 'Caudal Block', 'Postoperative Analgesia', 'Children', 'Inguinal Herniorrhaphy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare ultrasound-guided transversalis fascia plane block and caudal block for postoperative analgesia in children undergoing inguinal herniorrhaphy.', 'detailedDescription': 'Surgical repair of inguinal hernia is one of the most common day-case surgeries in the pediatric population. It is associated with significant postoperative pain and discomfort.\n\nCaudal block analgesia is a popular and reliable technique for lower abdominal surgeries and found to be safe and effective for providing intra and postoperative analgesia in pediatric patients.\n\ntransversal fascia plane block (TFPB) aims to provide analgesia for invasive procedures of the inguinal and sublingual areas by blocking the subcostal (T12), ilioinguinal (L1) and iliohypogastric (T12-L1) nerves. Several studies have reported TFPB as the analgesic method of choice for procedures involving the T12-L1 dermatome region, including iliac bone graft harvesting, cesarean section, and inguinal hernia repair'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age from 1 to 7 years.\n* Both sexes.\n* American Society of Anesthesiology (ASA) physical status I-II.\n* Scheduled for inguinal herniorrhaphy under general anesthesia (GA).\n\nExclusion Criteria:\n\n* Repeated surgeries.\n* Known allergic reactions to any of the study's drugs.\n* Infection at the site of block needle entry.\n* Bleeding diathesis.\n* Neurological disorders."}, 'identificationModule': {'nctId': 'NCT06725667', 'briefTitle': 'Ultrasound-Guided Transversalis Fascia Plane Block Versus Caudal Block for Postoperative Analgesia in Children Undergoing Inguinal Herniorrhaphy', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Ultrasound-Guided Transversalis Fascia Plane Block Versus Caudal Block for Postoperative Analgesia in Children Undergoing Inguinal Herniorrhaphy: A Randomized Controlled Non-Inferiority Trial', 'orgStudyIdInfo': {'id': '36264PR935/11/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transversalis fascia plane block group', 'description': 'Patients will receive transversalis fascia plane block after the induction of general anesthesia.', 'interventionNames': ['Other: Transversalis fascia plane block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Caudal block group', 'description': 'Patients will receive caudal block after the induction of general anesthesia.', 'interventionNames': ['Other: Caudal block']}], 'interventions': [{'name': 'Transversalis fascia plane block', 'type': 'OTHER', 'description': 'Patients will receive transversalis fascia plane block after the induction of general anesthesia.', 'armGroupLabels': ['Transversalis fascia plane block group']}, {'name': 'Caudal block', 'type': 'OTHER', 'description': 'Patients will receive caudal block after the induction of general anesthesia.', 'armGroupLabels': ['Caudal block group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Mohammed Said ElSharkawy', 'investigatorAffiliation': 'Tanta University'}}}}