Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT06098105
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2023-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2023-10-19', 'studyFirstSubmitQcDate': '2023-10-23', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total postoperative pethidine consumption', 'timeFrame': '24 hours postoperatively', 'description': 'The patient will be given supplementary paracetamol I.V. injection in a dose of 15 mg/kg as routine analgesia. If the FLACC score is \\> 3, pethidine 0.5 mg/kg.'}], 'secondaryOutcomes': [{'measure': 'Post-operative pain scores', 'timeFrame': '24 hours postoperatively', 'description': 'Face, Legs, Activity, Cry and Consolability (FLACC) scale will be used for postoperative pain assessment. This scale ranges from 0 to 10 where 0 represents no pain and 10 represents worst possible pain.\n\nFLACC scale will be measured at 30 minutes and then at 2, 4, 6, 12, 18 and 24 hours.'}, {'measure': 'Time of first analgesia request.', 'timeFrame': '24 hours postoperatively', 'description': 'Time of first analgesic requirement, which represent the time elapsed from the end of the surgery till the first request of rescue analgesia.'}, {'measure': 'Incidence of adverse events', 'timeFrame': '24 hours postoperatively', 'description': 'Complication related to the block or adverse events of the administered drugs.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Laparoscopic', 'Ultrasound', 'Transversus Abdominis Plane Block', 'Laparoscopic Intraperitoneal Instillation', 'Pediatrics', 'Inguinal Hernia Repair']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare laparoscopic -assisted, ultrasound-guided transversus abdominis plane block and laparoscopic intraperitoneal instillation of local anesthetic in pediatrics undergoing inguinal hernia repair.', 'detailedDescription': 'Inguinal hernia is one of the most common pediatric surgeries. Effective and safe pain management causes fewer side effects and enables faster hospital discharge. It is also important in overcoming chronic pain in the late postoperative period.\n\nTransversus abdominis plane block (TAPB) has emerged as a safe, simple, and inexpensive modality incorporated into many enhanced recovery pathways to achieve narcotic-sparing analgesia after bariatric surgery. TAPB was first performed through the lumbar triangle of Petit in 2001. Since that time, both ultrasound-guided (US) and laparoscopic (LAP) TAPBs have been developed to aid in proper identification of the correct plane and minimize peritoneal penetration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 2 months to 7 years old\n* Both sexes.\n* American Society of Anesthesiologists (ASA) I-II.\n* Schedule for elective unilateral inguinal hernia repair.\n\nExclusion Criteria:\n\n* Patients with history of allergy.\n* Hepatic and renal failure.\n* Previous inguinal surgery.\n* Block contraindications (e.g., infection at the site of block, bleeding disorder, or abnormalities of the sacrum).'}, 'identificationModule': {'nctId': 'NCT06098105', 'briefTitle': 'Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics Undergoing Inguinal Hernia Repair: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '36264PR352/9/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound-guided transversus abdominis plane block', 'description': 'This group will receive Ultrasound-guided transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL as a control group.', 'interventionNames': ['Procedure: Ultrasound-guided transversus abdominis plane block', 'Drug: Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Laparoscopic-assisted transversus abdominis plane block', 'description': 'Patients will receive Laparoscopic-assisted transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL.', 'interventionNames': ['Procedure: Laparoscopic-assisted transversus abdominis plane block', 'Drug: Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Laparoscopic-assisted intraperitoneal instillation', 'description': 'This group will receive Laparoscopic-assisted intraperitoneal instillation by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL will be instilled into the peritoneal cavity immediately after gas insufflation.', 'interventionNames': ['Procedure: Laparoscopic-assisted intraperitoneal instillation', 'Drug: Bupivacaine']}], 'interventions': [{'name': 'Ultrasound-guided transversus abdominis plane block', 'type': 'PROCEDURE', 'description': 'This group will receive ultrasound-guided transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL as a control group.', 'armGroupLabels': ['Ultrasound-guided transversus abdominis plane block']}, {'name': 'Laparoscopic-assisted transversus abdominis plane block', 'type': 'PROCEDURE', 'description': 'Patients will receive laparoscopic-assisted transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL.', 'armGroupLabels': ['Laparoscopic-assisted transversus abdominis plane block']}, {'name': 'Laparoscopic-assisted intraperitoneal instillation', 'type': 'PROCEDURE', 'description': 'This group will receive laparoscopic-assisted intraperitoneal instillation by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL will be instilled into the peritoneal cavity immediately after gas insufflation.', 'armGroupLabels': ['Laparoscopic-assisted intraperitoneal instillation']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'bupivacaine', 'armGroupLabels': ['Laparoscopic-assisted intraperitoneal instillation', 'Laparoscopic-assisted transversus abdominis plane block', 'Ultrasound-guided transversus abdominis plane block']}]}, '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', 'investigatorFullName': 'ِAhmed Mohamed Ibrahim', 'investigatorAffiliation': 'Tanta University'}}}}