Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-27 @ 11:50 AM
Study NCT ID:
NCT01136668
Status:
TERMINATED
Last Update Posted:
2021-06-08
First Post:
2010-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jason.hayes@sickkids.ca', 'phone': '416-813-7445', 'title': 'Dr. Jason Hayes', 'organization': 'Hospital for Sick Children'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment Group', 'description': 'Bupivacine-TAP block\n\nTransversus Abdominis Plane Block: A high frequency (5-10 mHz) ultrasound probe (Sonosite Micromaxx, Licence No 12407) will be placed on the flank at the midpoint between the iliac crest and lower costal margin. The three muscle layers of external oblique, internal oblique, and transversus abdominis will be visualized. A 22G short-bevel block needle will be advanced in an anterior-to-posterior direction, in-plane with the probe, until the tip is visualized in the transversus abdominis plane. After negative aspiration, 0.4 ml/kg of bupivacaine 0.25% with 1:200,000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Bupivacaine- wound infiltration\n\nStandard: Circumferential subcutaneous infiltration of the ostomy wound with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg by the surgeon after skin closure.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Morphine Requirement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'Transversus Abdominis Plane Block: A high frequency (5-10 mHz) ultrasound probe (Sonosite Micromaxx, Licence No 12407) will be placed on the flank at the midpoint between the iliac crest and lower costal margin. The three muscle layers of external oblique, internal oblique, and transversus abdominis will be visualized. A 22G short-bevel block needle will be advanced in an anterior-to-posterior direction, in-plane with the probe, until the tip is visualized in the transversus abdominis plane. After negative aspiration, 0.4 ml/kg of bupivacaine 0.25% with 1:200,000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard: Circumferential subcutaneous infiltration of the ostomy wound with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg by the surgeon after skin closure.'}], 'timeFrame': 'within the first 48 hours after surgery', 'description': 'The primary endpoint will be the proportion of children in each group requiring two or more (≥ 2) boluses of morphine in the PACU.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Group', 'description': 'Transversus Abdominis Plane Block: A high frequency (5-10 mHz) ultrasound probe (Sonosite Micromaxx, Licence No 12407) will be placed on the flank at the midpoint between the iliac crest and lower costal margin. The three muscle layers of external oblique, internal oblique, and transversus abdominis will be visualized. A 22G short-bevel block needle will be advanced in an anterior-to-posterior direction, in-plane with the probe, until the tip is visualized in the transversus abdominis plane. After negative aspiration, 0.4 ml/kg of bupivacaine 0.25% with 1:200,000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Standard: Circumferential subcutaneous infiltration of the ostomy wound with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg by the surgeon after skin closure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Group', 'description': 'Transversus Abdominis Plane Block: A high frequency (5-10 mHz) ultrasound probe (Sonosite Micromaxx, Licence No 12407) will be placed on the flank at the midpoint between the iliac crest and lower costal margin. The three muscle layers of external oblique, internal oblique, and transversus abdominis will be visualized. A 22G short-bevel block needle will be advanced in an anterior-to-posterior direction, in-plane with the probe, until the tip is visualized in the transversus abdominis plane. After negative aspiration, 0.4 ml/kg of bupivacaine 0.25% with 1:200,000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Standard: Circumferential subcutaneous infiltration of the ostomy wound with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg by the surgeon after skin closure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2', 'spread': '2', 'groupId': 'BG000'}, {'value': '7', 'spread': '11', 'groupId': 'BG001'}, {'value': '5', 'spread': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Unable to recruit adequate number of subjects', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-12', 'studyFirstSubmitDate': '2010-06-02', 'resultsFirstSubmitDate': '2018-04-17', 'studyFirstSubmitQcDate': '2010-06-02', 'lastUpdatePostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-12', 'studyFirstPostDateStruct': {'date': '2010-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine Requirement', 'timeFrame': 'within the first 48 hours after surgery', 'description': 'The primary endpoint will be the proportion of children in each group requiring two or more (≥ 2) boluses of morphine in the PACU.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pediatrics', 'Transversus Abdominis Plane Block', 'Ostomy Surgery', 'Anesthesia', 'Regional Anesthetic'], 'conditions': ['Anesthesia', 'Ostomy']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine if the use of Transversus Abdominis Plane (TAP) blocks reduce early postoperative opioid requirements.', 'detailedDescription': 'Revision or closure of ostomy is a common elective surgical procedure at The Hospital for Sick Children. A retrospective audit conducted at SickKids demonstrated significant intraoperative opioid use and significant requirements for rescue opioids in recovery.\n\nConcerns exist regarding the relative merits of opioid use in abdominal surgery. Opioids may decrease bowel motility leading to the increased incidence and duration of postoperative ileus. They may be associated with increased rates of post-operative nausea and vomiting and pruritus. Lastly children may under-report their pain or pain may not be recognized by medical staff leading to inadequate provision of analgesia. This suggests that the use of a regional technique may benefit children undergoing revision of ostomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children undergoing revision or closure of ostomy\n* American Society of Anesthesiologists Classification 1-3.\n* age ≥ 3 months\n\nExclusion Criteria:\n\n* children undergoing an additional surgical procedure (e.g. circumcision) at an anatomical location not covered by a one-sided/ unilateral TAP block, during the same anesthetic\n* children in whom a TAP block is contraindicated, i.e. surgical scar or distorted anatomy at the site of injection\n* postoperative admission to the intensive care unit\n* children with a known allergy to bupivacaine\n* children with a history of chronic abdominal pain\n* use of opioid analgesics prior to surgery\n* pregnancy\n* impaired renal function\n* impaired hepatic function\n* known impaired cardiac function\n* hypersensitivity to sodium metabisulfite'}, 'identificationModule': {'nctId': 'NCT01136668', 'briefTitle': 'Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery: A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1000014754'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Bupivacine-TAP block', 'interventionNames': ['Procedure: Transversus Abdominis Plane Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Bupivacaine- wound infiltration', 'interventionNames': ['Procedure: Standard']}], 'interventions': [{'name': 'Transversus Abdominis Plane Block', 'type': 'PROCEDURE', 'description': 'A high frequency (5-10 mHz) ultrasound probe (Sonosite Micromaxx, Licence No 12407) will be placed on the flank at the midpoint between the iliac crest and lower costal margin. The three muscle layers of external oblique, internal oblique, and transversus abdominis will be visualized. A 22G short-bevel block needle will be advanced in an anterior-to-posterior direction, in-plane with the probe, until the tip is visualized in the transversus abdominis plane. After negative aspiration, 0.4 ml/kg of bupivacaine 0.25% with 1:200,000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.', 'armGroupLabels': ['Treatment group']}, {'name': 'Standard', 'type': 'PROCEDURE', 'description': 'Circumferential subcutaneous infiltration of the ostomy wound with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg by the surgeon after skin closure.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Jason Hayes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children, Toronto Canada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Anesthesiologist', 'investigatorFullName': 'Jason Hayes', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}