Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-03-01 @ 3:01 PM
Study NCT ID:
NCT03729427
Status:
WITHDRAWN
Last Update Posted:
2025-05-04
First Post:
2018-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rib Microtia and the Erector Spinae Plane (ESP) Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065817', 'term': 'Congenital Microtia'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No participants were enrolled in the study due to numerous transitions of research staff and support since 2018.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2018-10-29', 'studyFirstSubmitQcDate': '2018-10-31', 'lastUpdatePostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opiate Intake in Morphine Equivalents in Both Control and Treatment Group', 'timeFrame': 'Duration of procedure and postoperative recovery (throughout study completion, typically 4-5 days)'}, {'measure': 'Evaluating Pain Scores Using 0-10 Numeric Pain Scale (0=No Pain, 10=Worst Pain)', 'timeFrame': 'Duration of Study (Typically 4-5 days)', 'description': 'Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours.'}, {'measure': 'Evaluating Pain Scores Using Wong-Baker FACES Pain Rating Scale', 'timeFrame': 'Duration of Study (Typically 4-5 days)', 'description': 'Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours.'}, {'measure': 'Evaluating Pain Scores Using Faces, Legs, Activity, Cry, and Consolability (FLACC) Scale', 'timeFrame': 'Duration of Study (Typically 4-5 days)', 'description': 'Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Erector Spinae Plane', 'Erector Spiane Plane Block', 'Rib Cartilage'], 'conditions': ['Microtia, Congenital', 'Microtia', 'Anesthesia, Local', 'Anesthesia']}, 'referencesModule': {'references': [{'pmid': '28919152', 'type': 'BACKGROUND', 'citation': 'Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.'}, {'pmid': '29301653', 'type': 'BACKGROUND', 'citation': 'Luftig J, Mantuani D, Herring AA, Dixon B, Clattenburg E, Nagdev A. Successful emergency pain control for posterior rib fractures with ultrasound-guided erector spinae plane block. Am J Emerg Med. 2018 Aug;36(8):1391-1396. doi: 10.1016/j.ajem.2017.12.060. Epub 2017 Dec 28.'}, {'pmid': '28203765', 'type': 'BACKGROUND', 'citation': 'Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block. This study is being performed to assess the effectiveness of this technique in reducing post-operative pain scores and opiate requirements in pediatric and adult patients undergoing rib cartilage grafting surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 2-17\n* Able to consent (if greater than 7 years) and have parental consent\n* Pediatric patients undergoing rib cartilage resection surgeries\n\nExclusion Criteria:\n\n* Participants who do not consent or have parental consent\n* Patients who are clinically unstable or requires urgent/emergent intervention'}, 'identificationModule': {'nctId': 'NCT03729427', 'briefTitle': 'Rib Microtia and the Erector Spinae Plane (ESP) Block', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Erector Spinae Plane Block for Rib Cartilage Graft Reconstruction Surgery', 'orgStudyIdInfo': {'id': '45160'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'description': 'ESP Block', 'interventionNames': ['Procedure: Erector Spinae Plane Block']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'Standard of Care'}], 'interventions': [{'name': 'Erector Spinae Plane Block', 'type': 'PROCEDURE', 'description': 'Erector Spinae Plane block for patents undergoing rib cartilage grafting surgeries', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital Stanford", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor-Med Ctr Line', 'investigatorFullName': 'Chi-Ho Ban Tsui', 'investigatorAffiliation': 'Stanford University'}}}}