Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-30 @ 1:35 PM
Study NCT ID:
NCT05063695
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2021-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pectus ESC Outcomes and Comparative Effectiveness Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005660', 'term': 'Funnel Chest'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2021-09-17', 'studyFirstSubmitQcDate': '2021-09-30', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': 'Upto 10 days after surgery', 'description': 'Date of surgery to hospital discharge'}, {'measure': 'Mobilization', 'timeFrame': 'After surgery in-hospital, phone calls until POD6, pain clinic and surgery clinic postop visit (within 4 weeks after surgery)', 'description': 'Meeting PT goals'}], 'secondaryOutcomes': [{'measure': 'Pain measures', 'timeFrame': 'After surgery in-hospital, phone calls until POD6, pain clinic and surgery clinic postop visit (within 4 weeks after surgery)', 'description': 'Pain scores postoperative and opioid/benzodiazepine use'}, {'measure': 'Side effects', 'timeFrame': 'After surgery in-hospital, phone calls until POD6, pain clinic and surgery clinic postop visit (within 4 weeks after surgery)', 'description': 'ED visit, readmission, numbness, infection, LA toxicity etc.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pectus Excavatum', 'Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '30346358', 'type': 'BACKGROUND', 'citation': 'Muhly WT, Beltran RJ, Bielsky A, Bryskin RB, Chinn C, Choudhry DK, Cucchiaro G, Fernandez A, Glover CD, Haile DT, Kost-Byerly S, Schnepper GD, Zurakowski D, Agarwal R, Bhalla T, Eisdorfer S, Huang H, Maxwell LG, Thomas JJ, Tjia I, Wilder RT, Cravero JP. Perioperative Management and In-Hospital Outcomes After Minimally Invasive Repair of Pectus Excavatum: A Multicenter Registry Report From the Society for Pediatric Anesthesia Improvement Network. Anesth Analg. 2019 Feb;128(2):315-327. doi: 10.1213/ANE.0000000000003829.'}, {'pmid': '29063665', 'type': 'BACKGROUND', 'citation': 'Man JY, Gurnaney HG, Dubow SR, DiMaggio TJ, Kroeplin GR, Adzick NS, Muhly WT. A retrospective comparison of thoracic epidural infusion and multimodal analgesia protocol for pain management following the minimally invasive repair of pectus excavatum. Paediatr Anaesth. 2017 Dec;27(12):1227-1234. doi: 10.1111/pan.13264. Epub 2017 Oct 24.'}, {'pmid': '32972738', 'type': 'BACKGROUND', 'citation': 'Gurria JP, Simpson B, Tuncel-Kara S, Bates C, McKenna E, Rogers T, Kraemer A, Platt M, Mecoli M, Garcia VF, Brown RL. Standardization of clinical care pathway leads to sustained decreased length of stay following Nuss pectus repair: A multidisciplinary quality improvement initiative. J Pediatr Surg. 2020 Dec;55(12):2690-2698. doi: 10.1016/j.jpedsurg.2020.08.009. Epub 2020 Aug 16.'}, {'pmid': '27501016', 'type': 'BACKGROUND', 'citation': 'Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.'}, {'pmid': '30292068', 'type': 'BACKGROUND', 'citation': 'Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.'}]}, 'descriptionModule': {'briefSummary': 'Investigators hypothesize that Erector spinae catheter pain management protocol would allow patients to have earlier and more effective rehabilitation with decreased length of hospital stay. The aims are to compare LOS between the two groups (epidural and ES groups). Secondary aims are to compare recovery outcomes (mobilization time), time required to do the blocks, pain scores and opioid use during hospitalization and on follow up after discharge until Pain clinic visit, side effects, family satisfaction and readmissions among the two groups. In addition, in-hospital and post-discharge outcomes in subjects who received ESP protocol will be studied.', 'detailedDescription': 'Retrospective study - Electronic medical records of consecutive patients who underwent pectus surgery between January and December of 2019 (epidural protocol) and those who underwent same procedure between June 2020 to May 2021, will be evaluated. Covariates and outcomes described in sections below will be recorded from EMR. The data included records from flowsheets, pain team notes based on follow up questionnaires administered by phone after discharge until after ESP catheters were removed, as well as pain clinic notes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with pectus excavatum who underwent Nuss procedure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>8 years\n* Diagnosis of pectus excavatum who underwent Nuss procedure\n* Pain regimen included either epidural catheter or ES catheters\n\nExclusion Criteria:\n\n* Developmental delay\n* prior pectus repair\n* concomitant procedures'}, 'identificationModule': {'nctId': 'NCT05063695', 'acronym': 'PectusESC', 'briefTitle': 'Pectus ESC Outcomes and Comparative Effectiveness Study', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Pragmatic Study Comparing Outcomes of Multimodal Epidural and Erector Spinae Catheter Pain Protocols After Pectus Surgery', 'orgStudyIdInfo': {'id': '2021-0374'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Epidural', 'description': 'Patients who underwent Nuss procedure under epidural protocol (between January and December of 2019)'}, {'label': 'ESP', 'description': 'Patients who underwent Nuss procedure using ESP catheter protocol (June 2020 to April 2021)', 'interventionNames': ['Other: Multimodal Erector spinae catheter protocol']}], 'interventions': [{'name': 'Multimodal Erector spinae catheter protocol', 'type': 'OTHER', 'otherNames': ['Multimodal epidural protocol'], 'description': 'Patients either received multimodal epidural or ESP protocol', 'armGroupLabels': ['ESP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Vidya Chidambaran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}