Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2026-01-22 @ 8:55 AM
Study NCT ID:
NCT05252650
Status:
UNKNOWN
Last Update Posted:
2022-02-23
First Post:
2022-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Pain Management in Cerebral Palsy - Comparative Observational Study"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'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': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-08-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-13', 'studyFirstSubmitDate': '2022-02-13', 'studyFirstSubmitQcDate': '2022-02-13', 'lastUpdatePostDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain score', 'timeFrame': '6 month', 'description': 'pain score with r-FLACC'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '21299684', 'type': 'RESULT', 'citation': 'Kim SH, Chun DH, Chang CH, Kim TW, Kim YM, Shin YS. Effect of caudal block on sevoflurane requirement for lower limb surgery in children with cerebral palsy. Paediatr Anaesth. 2011 Apr;21(4):394-8. doi: 10.1111/j.1460-9592.2011.03530.x. Epub 2011 Feb 8.'}, {'pmid': '28197774', 'type': 'RESULT', 'citation': 'Ozkan D, Gonen E, Akkaya T, Bakir M. Popliteal block for lower limb surgery in children with cerebral palsy: effect on sevoflurane consumption and postoperative pain (a randomized, double-blinded, controlled trial). J Anesth. 2017 Jun;31(3):358-364. doi: 10.1007/s00540-017-2318-2. Epub 2017 Feb 14.'}, {'type': 'RESULT', 'citation': 'Evreinov, V. V., & Zhirova, T. A. (2020). Regional anesthetic techniques for hip surgery in children with cerebral palsy. Genij Ortopedii, 26(4), 521-256.'}, {'pmid': '29911640', 'type': 'RESULT', 'citation': 'Pedersen LK, Rahbek O, Nikolajsen L, Moller-Madsen B. The revised FLACC score: Reliability and validation for pain assessment in children with cerebral palsy. Scand J Pain. 2015 Oct 1;9(1):57-61. doi: 10.1016/j.sjpain.2015.06.007.'}]}, 'descriptionModule': {'briefSummary': 'In this study, our aim is to examine orthopedic interventions, anesthesia method, postoperative pain level and management applied to patients with CP in biruni university hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '130 patients aged 3-15 years with a diagnosis of cerebral palsy, category 2 according to the Classification of the American Society of Anesthesiology (ASA 2), who underwent soft tissue release for knee or ankle flexion contracture of the lower extremity with palliative or reconstructive hip interventions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with cerebral palsy between the ages of 3-15,\n* Category 2 according to the Classification of the American Society of Anesthesiology (ASA 2),\n* patients undergoing soft tissue release for knee or ankle flexion contracture of the lower extremity with palliative or reconstructive hip interventions\n\nExclusion Criteria:\n\n* Any child with CP younger than 3 years old and older than 15 years has undergone\n* procedures without a specific diagnosis of CP,\n* the need for bone surgery,\n* requiring both hip, knee and ankle surgery in the same session,\n* with autonomic neuropathy,\n* Patients with a history of anticholinergic and vasoactive drug use or allergy to amide type local anesthetics'}, 'identificationModule': {'nctId': 'NCT05252650', 'briefTitle': 'Postoperative Pain Management in Cerebral Palsy - Comparative Observational Study"', 'organization': {'class': 'OTHER', 'fullName': 'Biruni University'}, 'officialTitle': 'Postoperative Pain Management in Pediatric Patients With Cerebral Palsy - Comparative Observational Study"', 'orgStudyIdInfo': {'id': 'biruni cp'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'regional block', 'description': 'epidural / peripheral nerve block', 'interventionNames': ['Behavioral: pain']}, {'label': 'intravenous', 'description': 'intravenous analgesia', 'interventionNames': ['Behavioral: pain']}], 'interventions': [{'name': 'pain', 'type': 'BEHAVIORAL', 'description': 'postoperative pain', 'armGroupLabels': ['intravenous', 'regional block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34250', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'ilke kupeli', 'role': 'CONTACT', 'email': 'ilkeser2004@gmail.com', 'phone': '05555485632'}], 'facility': 'Ilke Kupeli', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'ilke kupeli', 'role': 'CONTACT', 'email': 'ilkeser2004@gmail.com', 'phone': '+905555485632'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biruni University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'investigator', 'investigatorFullName': 'ILKE KUPELI', 'investigatorAffiliation': 'Biruni University'}}}}