Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-25 @ 6:35 PM
Study NCT ID:
NCT02009267
Status:
COMPLETED
Last Update Posted:
2017-02-02
First Post:
2013-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nuss Procedure: Clinical Options in Pediatric Pain Management?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005660', 'term': 'Funnel Chest'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016058', 'term': 'Analgesia, Patient-Controlled'}], 'ancestors': [{'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-01', 'studyFirstSubmitDate': '2013-11-19', 'studyFirstSubmitQcDate': '2013-12-06', 'lastUpdatePostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total morphine dose', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 3 days', 'description': 'Total morphine dose will be evaluated in mg/kg/24 hour period, beginning with post-op day 0 until discharge from the hospital.'}], 'secondaryOutcomes': [{'measure': 'Pain score', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 3 days', 'description': 'Pain scores obtained from the visual analog scale.'}, {'measure': 'Length of hospitalization', 'timeFrame': 'Within the first week after surgery.', 'description': 'Determine if there is a difference in length of hospitalization, and time to discharge.'}, {'measure': 'Nausea and vomiting', 'timeFrame': '0-48 hrs. post-op', 'description': 'Determine the incidence of nausea and vomiting measured by the postoperative ondansetron dosing, beginning with arrival to floor and up to the first 48 hrs of hospitalization.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pectus Excavatum']}, 'descriptionModule': {'briefSummary': 'A retrospective chart review study analyzing the benefits of patient controlled analgesia, thoracic epidural analgesia, and paravertebral nerve block catheters in patients having surgical repair of pectus excavatum using the Nuss procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients undergoing the Nuss procedure to correct pectus excavatum at Nationwide Children's Hospital.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing the NUSS procedure since the beginning of 2011 to Sept. 30th, 2013.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02009267', 'briefTitle': 'Nuss Procedure: Clinical Options in Pediatric Pain Management?', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'orgStudyIdInfo': {'id': 'IRB13-00702'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient controlled analgesia', 'description': 'Use of patient controlled analgesia (PCA) for the management of postoperative pain after the Nuss procedure.', 'interventionNames': ['Device: Patient controlled analgesia']}, {'label': 'Continuous thoracic epidural infusion', 'description': 'Continuous thoracic epidural infusions (TE) for the management of postoperative pain after the Nuss procedure.', 'interventionNames': ['Procedure: Continuous thoracic epidural infusions']}, {'label': 'Continuous paravertebral blockade', 'description': 'Continuous paravertebral blockade (PVB) for the management of postoperative pain after the Nuss procedure.', 'interventionNames': ['Procedure: Continuous paravertebral blockade']}], 'interventions': [{'name': 'Patient controlled analgesia', 'type': 'DEVICE', 'description': 'A programable electronically controlled infusion pump that delivers an amount of intravenous analgesic when the patient presses a button.', 'armGroupLabels': ['Patient controlled analgesia']}, {'name': 'Continuous thoracic epidural infusions', 'type': 'PROCEDURE', 'description': 'Continuous thoracic epidural infusions (TE) involves continuous infusion of drugs through a catheter placed into the epidural space, resulting in a loss of sensation-including the sensation of pain-by blocking the transmission of signals through nerve fibers in or near the spinal cord.', 'armGroupLabels': ['Continuous thoracic epidural infusion']}, {'name': 'Continuous paravertebral blockade', 'type': 'PROCEDURE', 'description': 'Continuous paravertebral blockade (PVB) is the technique of injecting local anesthetic adjacent to the thoracic vertebra that anesthetizes the spinal nerve roots after they exit the spinal canal.', 'armGroupLabels': ['Continuous paravertebral blockade']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Beltran Ralph, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nationwide Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ralph Beltran', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Clinical Professor', 'investigatorFullName': 'Ralph Beltran', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}