Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-28 @ 7:09 PM
Study NCT ID:
NCT04202367
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2019-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Different Bupivacaine Concentrations in Pediatric Patients Undergoing Transversus Abdominis Plane Block
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Seventy-four patients aging between 1 and 8 years, undergoing unilateral inguinal hernia surgery, were enrolled in the study and were randomized using closed envelope method.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Ultrasound-guided TAP block was applied following standard general anaesthesia induction. All patients received remifentanil 0,1 μg/kg/h infusion and paracetamol 15 mg/kg intraoperatively, and paracetamol 4x15 mg/kg per day postoperatively.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-16', 'studyFirstSubmitDate': '2019-12-16', 'studyFirstSubmitQcDate': '2019-12-16', 'lastUpdatePostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FLACC pediatric pain scores', 'timeFrame': 'up to 24 hours', 'description': 'It corporates five categories of behavior, each scored on 0-2 point scale so that total score ranges from 0-10.'}], 'secondaryOutcomes': [{'measure': 'Total analgesic requirement', 'timeFrame': 'up to 24 hours', 'description': 'Tramadol'}, {'measure': 'First analgesic requirement time', 'timeFrame': 'up to 24 hours', 'description': 'Duration of postoperative analgesia'}, {'measure': 'Incidence of side effects', 'timeFrame': 'up to 24 hours', 'description': 'Nausea, vomiting, respiratory depression'}, {'measure': 'The length of hospital stay', 'timeFrame': 'up to 24 hours', 'description': 'Hospitalisation hours'}, {'measure': 'Incidence of complications', 'timeFrame': 'up to first week.', 'description': 'Hemotoma, infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transversus abdominis plane block', 'Bupivacaine', 'Concentration', 'Postoperative analgesia', 'Inguinal hernia repair surgery'], 'conditions': ['Transversus Abdominis Plane Block']}, 'referencesModule': {'references': [{'pmid': '36411426', 'type': 'DERIVED', 'citation': 'Karadeniz MS, Atasever AG, Salviz EA, Bingul ES, Ciftci HS, Dincer MB, Sungur MO. Transversus abdominis plane block with different bupivacaine concentrations in children undergoing unilateral inguinal hernia repair: a single-blind randomized clinical trial. BMC Anesthesiol. 2022 Nov 21;22(1):355. doi: 10.1186/s12871-022-01907-y.'}]}, 'descriptionModule': {'briefSummary': "This study is designed to compare the analgesic efficacy of different bupivacaine concentrations in pediatric patients undergoing ultrasound-guided transversus abdominis plane (TAP) block for unilateral inguinal hernia repair. In recruited 74 patients; Group 1 (n:37) received 1 mg/kg bupivakain 0.25% and Group 2 (n: 37) received 1 mg/kg bupivakain 0.125% for ultrasound-guided TAP block following standard general anaesthesia induction. FLACC (Face, Legs, Activity, Cry, Consolability) behavioral pain assessment scale was used for evaluating patients' postoperative pain levels at 15-, 30-, 45-minute and 1-, 2-, 6-, 24-hour. Tramadol 1 mg/kg was administered intravenously as rescue analgesic when FLACC score was ≥4. Total analgesic requirement, length of hospital stay and side effects were recorded.", 'detailedDescription': "Transversus abdominis plane (TAP) block is a safe and effective analgesia technique for paediatric patients. This study is designed to compare the analgesic efficacy of different bupivacaine concentrations in paediatric patients undergoing ultrasound-guided TAP blocks for unilateral inguinal hernia repair surgery. Seventy-four patients aging between 1 and 8 years, undergoing unilateral inguinal hernia surgery, were enrolled for this study after obtaining Institutional Ethics Committee approval and written informed consents from parents or legal guardians (2016/1281). Group 1 (n:37) received 1 mg/kg bupivakain 0.25% and Group 2 (n: 37) received 1 mg/kg bupivakain 0.125% for ultrasound-guided TAP block following standard general anaesthesia induction. All patients received remifentanil 0,1 μg/kg/h infusion and paracetamol 15 mg/kg intraoperatively, and paracetamol 4x15 mg/kg per day postoperatively. FLACC (Face, Legs, Activity, Cry, Consolability) behavioral pain assessment scale was used for evaluating patients' postoperative pain levels at 15-, 30-, 45-minute and 1-, 2-, 6-, 24-hour. Tramadol 1 mg/kg was administered intravenously as rescue analgesic when FLACC score was ≥4. Total analgesic requirement, length of hospital stay and side effects were recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) status I/II\n* Children between 1 to 8 years of age\n* Patients undergoing unilateral inguinal hernia repair surgery\n\nExclusion Criteria:\n\n* Denial of parents\n* Patients who are allergic to local anesthetics'}, 'identificationModule': {'nctId': 'NCT04202367', 'briefTitle': 'The Efficacy of Different Bupivacaine Concentrations in Pediatric Patients Undergoing Transversus Abdominis Plane Block', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Transversus Abdominis Plane (TAP) Block With Different Bupivacaine Concentrations in Pediatric Patients Undergoing Unilateral Inguinal Hernia Repair Surgery: A Prospective Randomised Double-Blinded Study', 'orgStudyIdInfo': {'id': '2016/1281'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TAP block with 1 mg.kg-1 bupivacaine 0.25%', 'description': 'Patients had 1 mg.kg-1 bupivacaine 0.25% with US-guided TAP block', 'interventionNames': ['Drug: 1 mg.kg-1 bupivacaine 0.25%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TAP block with 1 mg.kg-1 bupivacaine 0.125%', 'description': 'Patients had 1 mg.kg-1 bupivacaine 0.125% with US-guided TAP block', 'interventionNames': ['Drug: 1 mg.kg-1 bupivacaine 0.125%']}], 'interventions': [{'name': '1 mg.kg-1 bupivacaine 0.25%', 'type': 'DRUG', 'otherNames': ['Marcaine'], 'description': 'Ultrasound-guided transversus abdominis plane block for unilateral inguinal hernia repair surgery.', 'armGroupLabels': ['TAP block with 1 mg.kg-1 bupivacaine 0.25%']}, {'name': '1 mg.kg-1 bupivacaine 0.125%', 'type': 'DRUG', 'otherNames': ['Marcaine'], 'description': 'Ultrasound-guided transversus abdominis plane block for unilateral inguinal hernia repair surgery.', 'armGroupLabels': ['TAP block with 1 mg.kg-1 bupivacaine 0.125%']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Meltem Savran Karadeniz, Assoc. Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University'}, {'name': 'Emine Aysu Salviz, Assoc. Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Istanbul University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Meltem Savran Karadeniz', 'investigatorAffiliation': 'Istanbul University'}}}}