Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2026-01-23 @ 12:02 AM
Study NCT ID:
NCT03790566
Status:
UNKNOWN
Last Update Posted:
2019-02-26
First Post:
2018-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erector Spinae Plane Block for Peri-operative Pain Management in Pediatric Open Pyeloplasty Cases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-09-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-25', 'studyFirstSubmitDate': '2018-12-28', 'studyFirstSubmitQcDate': '2018-12-28', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remifentanil need', 'timeFrame': 'During the operation', 'description': 'Intraoperative remifentanil requirement as rescue analgesia'}, {'measure': 'Post-operative analgesia need', 'timeFrame': '24 hours post-operatively', 'description': 'Pain score is assessed with FLACC (Face, Legs, Activity, Cry, Consolability) scale. A score of 2, 3, 4 or 5 warrants for intravenous paracetamol need and a score of 6 and above warrants for intravenous tramadol'}], 'secondaryOutcomes': [{'measure': 'Parental satisfaction with analgesia', 'timeFrame': '24 hours post-operatively', 'description': "Parents will be asked how satisfied they are with the patient's pain control: 1. Dissatisfied, 2. Partially satisfied 3. Satisfied"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ESP block', 'TAP block', 'pyeloplasty', 'erector spina plane block', 'transversus abdominus plane block', 'flank incision', 'post-op analgesia', 'peri-op analgesia'], 'conditions': ['Anesthesia and Analgesia', 'Pediatrics', 'Urologic Surgical Procedures']}, 'descriptionModule': {'briefSummary': 'Regional anesthesia decreases the need for intravenous analgesia in the peri-operative period. Erector spinae plane (ESP) and transversus abdominus plane (TAP) blocks are two common regional anesthesia techniques shown to be effective in open abdominal surgeries. We aim to compare effectiveness of ESP block with TAP block for peri-operative analgesia in pediatric open pyeloplasty patients with a flank incision.', 'detailedDescription': 'Regional anesthesia for effective post-operative pain management is a part of the pediatric Enhanced Recovery After Surgery (ERAS) protocol. Epidural anesthesia is the gold standard for analgesia for open abdominal surgeries, however difficulties in application and possible complications deter clinicians from utilizing this method. Safe and effective alternatives to epidural anesthesia has been a critical and popular focus of clinical research in recent years. Transversus abdominus plane (TAP) block is an alternative technique shown to be effective in pediatric open abdominal surgeries.\n\nErector spinae plane (ESP) block was described as an effective block for multi-dermatome pain after thoracic surgery. It is emerging as a safe and easy-to-perform alternative to epidural anesthesia for pelvic, abdominal and thoracic surgery.\n\nDuring an open pyeloplasty, the flank incision goes through the transversus abdominus plane, where the local anesthetic is injected for TAP block. This may weaken the analgesic effect of the block. In the ESP block, local anesthetic diffuses cranio-caudally through the fascia of erector spinae muscles and the flank incision does not disturb this plane. We aim to compare the effectiveness of ESP block with TAP block in open pyeloplasty patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologist class I, II or III\n* Patients scheduled for elective open pyeloplasty surgery\n\nExclusion Criteria:\n\n* Local anesthetic allergy or other contraindication to local anesthetic use\n* Coagulation disorders\n* History of chronic pain\n* Patient/Family refusal\n* History of scoliosis, spinae bifida, abdominal wall defect\n* Past surgical procedures with abdominal wall incision\n* Plan to extend the flank incision for additional surgical intervention'}, 'identificationModule': {'nctId': 'NCT03790566', 'acronym': 'ESPPOP', 'briefTitle': 'Erector Spinae Plane Block for Peri-operative Pain Management in Pediatric Open Pyeloplasty Cases', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Comparison of Erector Spinae Plane Block With Transversus Abdominus Plane Block for Peri-operative Pain Management in Pediatric Open Pyeloplasty Cases', 'orgStudyIdInfo': {'id': '72109855-604.01.01-53213'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erector spinae plane block', 'description': 'With the patient in lateral decubitus position (surgical side up), the transverse processes of T10-T12 vertebrae and erector spinae (ES) fascia are visualized 1-2 cm lateral to the vertebral spine using a linear ultrasound probe. A 22G peripheral block needle is introduced with in-plane technique under the ES muscle and local anesthetic solution (0.5 ml/kg 0.25% bupivacaine) is injected in this plane after a test injection with 0.5 ml of 0.9% NaCl solution to visualize opening of ESP.', 'interventionNames': ['Drug: Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transversus abdominus plane block', 'description': 'With the patient in supine position, three layers of abdominal muscle are visualized using the linear ultrasound probe held with the long axis on the mid-axillary line above the iliac crest. 22G peripheral block needle is introduced in-plane into the fascia between the internal oblique and transversus abdominus muscles and local anesthetic solution (0.5 ml/kg 0.25% bupivacaine) is injected in this plane after a test injection with 0.5 ml of 0.9% NaCl solution to visualize opening of ESP.', 'interventionNames': ['Drug: Bupivacaine']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'description': '0.5 ml/kg 0.25% bupivacaine', 'armGroupLabels': ['Erector spinae plane block', 'Transversus abdominus plane block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34098', 'city': 'Istanbul', 'state': 'Please Select', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Pinar Kendigelen, Assoc.Prof.', 'role': 'CONTACT', 'email': 'pinarken@gmail.com', 'phone': '+905325868734'}, {'name': 'Aybike Onur Gonen, MD', 'role': 'CONTACT', 'email': 'aybikeonur@gmail.com', 'phone': '+905322701086'}, {'name': 'Pınar Kendigelen, Assoc.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ayse C Tutuncu, Prof', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Guner Kaya, Prof', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Aybike Onur Gonen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rahsan Ozcan, Assoc.Prof.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Istanbul University Cerrahpasa Medical Faculty', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Pinar Kendigelen, Assoc. Prof.', 'role': 'CONTACT', 'email': 'pinarken@gmail.com', 'phone': '+905325868734'}, {'name': 'Aybike Onur Gonen, MD', 'role': 'CONTACT', 'email': 'aybikeonur@gmail.com', 'phone': '+905322701086'}], 'overallOfficials': [{'name': 'Pinar Kendigelen, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University Cerrahpasa Medical Faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aybike Onur Gonen', 'class': 'UNKNOWN'}, {'name': 'Ayse Cigdem Tutuncu', 'class': 'OTHER'}, {'name': 'Kaya, Guner, M.D.', 'class': 'INDIV'}, {'name': 'Rahsan Ozcan', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'pinar kendigelen', 'investigatorAffiliation': 'Istanbul University'}}}}