Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-01-07 @ 9:18 AM
Study NCT ID:
NCT04822935
Status:
COMPLETED
Last Update Posted:
2021-11-19
First Post:
2021-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Pain in Adolescent Idiopathic Scoliosis Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-18', 'studyFirstSubmitDate': '2021-01-30', 'studyFirstSubmitQcDate': '2021-03-26', 'lastUpdatePostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison in terms of postoperative pain', 'timeFrame': '48 hours', 'description': 'Opioid consumption and VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable) for measurement of postoperative pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scoliosis; Adolescence']}, 'referencesModule': {'references': [{'pmid': '35793183', 'type': 'DERIVED', 'citation': 'Canbolat N, Basaran I, Altun D, Akgul T, Buget MI. Postoperative Pain in Adolescent Idiopathic Scoliosis Surgery: A Randomized Controlled Trial. Pain Physician. 2022 Jul;25(4):E589-E596.'}]}, 'descriptionModule': {'briefSummary': 'Scoliosis is a 3-dimensional, structural deformity of the spine. Idiopathic scoliosis is the most common type and it constitutes 75-80% of all scoliosis. Surgical methods are the most effective way to correct the deformity in patients who cannot achieve adequate improvement with supportive therapy. Adolescent idiopathic scoliosis surgeries are among the most invasive surgeries performed on children and adolescents. Large surgical incision and massive tissue damage cause severe postoperative pain. In this study, we aim to compare posterior instrumentation (PE) and vertebral body tethering (VBT) surgeries performed in adolescent idiopathic scoliosis patients in terms of anesthetic management and postoperative pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA score 1-3 patients\n* Adolescent idiopathic scoliosis patients\n* Patients who accepted to be included in the study and received written parental consent\n\nExclusion Criteria:\n\n* Patients with vertebral anomaly due to a secondary reason\n* Patients with a diagnosed syndrome\n* Patients with a Cobb angle below 40.\n* Patients who undergoing reoperation'}, 'identificationModule': {'nctId': 'NCT04822935', 'briefTitle': 'Postoperative Pain in Adolescent Idiopathic Scoliosis Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Evaluation of Surgical Methods in Terms of Postoperative Pain in Adolescent Idiopathic Scoliosis', 'orgStudyIdInfo': {'id': '2020/1561'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Posterior Spinal Instrumentation'}, {'type': 'EXPERIMENTAL', 'label': 'Vertebral Body Tethering', 'interventionNames': ['Procedure: Vertebral Body Tethering']}], 'interventions': [{'name': 'Vertebral Body Tethering', 'type': 'PROCEDURE', 'description': 'VBT surgery is a surgery performed by thoracotomy in adolescent idiopathic scoliosis patients.', 'armGroupLabels': ['Vertebral Body Tethering']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University Istanbul Medical Faculty', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Irem Basaran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, M.D.', 'investigatorFullName': 'Nur Canbolat', 'investigatorAffiliation': 'Istanbul University'}}}}