Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT04212832
Status:
COMPLETED
Last Update Posted:
2019-12-30
First Post:
2019-12-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quadratus Lumborum Block for Congenital Hip Dislocation Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006618', 'term': 'Hip Dislocation, Congenital'}], 'ancestors': [{'id': 'D000082602', 'term': 'Developmental Dysplasia of the Hip'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-25', 'studyFirstSubmitDate': '2019-12-25', 'studyFirstSubmitQcDate': '2019-12-25', 'lastUpdatePostDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Face, Legs, Activity, Cry and Consolability Score (FLACC)', 'timeFrame': 'Postoperative first 24hour', 'description': 'FLACC scale will be used. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.'}], 'secondaryOutcomes': [{'measure': 'Need for rescue analgesic', 'timeFrame': '2 hour', 'description': 'Number of patients who required rescue analgesia in postoperative care unit in the first 2 hour'}, {'measure': 'Need for analgesic', 'timeFrame': '24 hour', 'description': 'Number of patients who required analgesic in the first 24 hour'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congenital Hip Dislocation']}, 'referencesModule': {'references': [{'pmid': '29807213', 'type': 'BACKGROUND', 'citation': 'Ahiskalioglu A, Yayik AM, Alici HA, Ezirmik N. Ultrasound guided transmuscular quadratus lumborum block for congenital hip dislocation surgery: Report of two pediatric cases. J Clin Anesth. 2018 Sep;49:15-16. doi: 10.1016/j.jclinane.2018.05.018. Epub 2018 May 26. No abstract available.'}, {'pmid': '30684924', 'type': 'BACKGROUND', 'citation': "Ahiskalioglu A, Yayik AM, Alici HA. Response to Ince et al.: Ultrasound-guided quadratus lumborum plane block for congenital hip dislocation surgery: Dermatomes and osteotomes 'J Clin Anesth. 2018;54:140'. J Clin Anesth. 2019 Sep;56:39-40. doi: 10.1016/j.jclinane.2019.01.022. Epub 2019 Jan 23. No abstract available."}, {'pmid': '30195631', 'type': 'BACKGROUND', 'citation': 'Yayik AM, Cesur S, Ozturk F, Ahiskalioglu A, Celik EC. [Continuous quadratus lumborum type 3 block provides effective postoperative analgesia for hip surgery: case report]. Braz J Anesthesiol. 2019 Mar-Apr;69(2):208-210. doi: 10.1016/j.bjan.2018.06.007. Epub 2018 Sep 6.'}, {'pmid': '30443064', 'type': 'BACKGROUND', 'citation': 'Tulgar S, Ermis MN, Ozer Z. Combination of lumbar erector spinae plane block and transmuscular quadratus lumborum block for surgical anaesthesia in hemiarthroplasty for femoral neck fracture. Indian J Anaesth. 2018 Oct;62(10):802-805. doi: 10.4103/ija.IJA_230_18.'}]}, 'descriptionModule': {'briefSummary': 'Developmental dysplasia of the hip (DDH) is one of the major disorder of the pediatric population with an incidence of 3 to 5 per 1000 children. Open surgical reduction of congenital hip dislocation (CHD) is typically performed after an ineffective closed reduction or older than 18 months. Multiple femoral or pelvic osteotomies and tenotomies are performed during this surgical treatment and cause severe postoperative pain.Since initial description for abdominal surgery, the quadratus lumborum block has experienced several surgeries for postoperative pain management in adults and pediatrics. One of these indication is the hip surgery and described for adult hip arthroplasty. In addition we reported two pediatric cases that single dose transmuscular quadratus lumborum block is an affective analgesia for CHD surgery. The aim of this study was to evaluate the analgesic effect of ultrasound guided transmuscular quadratus lumborum block in pediatric patients undergoing CHD surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- American Society of Anesthesiologist's physiologic state I-II patients undergoing hip dislocation surgery\n\nExclusion Criteria:\n\n* chronic pain\n* bleeding disorders\n* renal or hepatic insufficiency\n* patients on chronic non-steroidal anti-inflammatory medications\n* emergency cases\n* Incomplete patient forms\n* infection of the skin at the site of needle puncture area\n* patients with known allergies to any of the study drugs\n* American Society of Anesthesiologist's III-IV"}, 'identificationModule': {'nctId': 'NCT04212832', 'briefTitle': 'Quadratus Lumborum Block for Congenital Hip Dislocation Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'Transmuscular Quadratus Lumborum Block Block for Congenital Hip Dislocation Surgery: Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'AUTFANESTHESIAHIPQLB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ultrasound guided quadratus lumborum block', 'description': 'ultrasound guided quadratus lumborum block with 0.5 ml/kg % 0.25 bupivacaine', 'interventionNames': ['Drug: Bupivacaine']}, {'type': 'OTHER', 'label': 'No intervention', 'description': 'Standard Pain Followup and Monitorization', 'interventionNames': ['Other: Standard pain']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'description': '0.5 ml/kg %0.25 bupivacaine', 'armGroupLabels': ['ultrasound guided quadratus lumborum block']}, {'name': 'Standard pain', 'type': 'OTHER', 'description': 'Standard pain follow up and monitorization', 'armGroupLabels': ['No intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25100', 'city': 'Erzurum', 'state': 'Yakutiye', 'country': 'Turkey (Türkiye)', 'facility': 'Ataturk University', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ali Ahiskalioglu', 'investigatorAffiliation': 'Ataturk University'}}}}