Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-01-01 @ 10:29 AM
Study NCT ID:
NCT05104203
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
2021-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TLIP Block Versus Modified TLIP Block for Posterior Decompression and Stabilization Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-31', 'studyFirstSubmitDate': '2021-07-21', 'studyFirstSubmitQcDate': '2021-10-31', 'lastUpdatePostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemodynamic', 'timeFrame': 'approximately 15 minutes within surgery', 'description': 'Stability of Hemodynamics that needs the fentanyl addition'}], 'secondaryOutcomes': [{'measure': 'qNox Score', 'timeFrame': 'before induction of anesthesia, 15, 30, 45 minutes after the block was done.', 'description': 'qNox score were taken before induction of anesthesia, 15, 30 and 45 minutes after the block done. the mean of 15,30 and 45 minutes qNox score was assesed'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Erector Spinae Plane Block', 'opioid consumption', 'numerical rating scale', 'Interleukin 10', 'Interleukin 6', 'Thoracolumbal Interfascial Plane Block'], 'conditions': ['Analgesia', 'Surgical Procedure, Unspecified']}, 'descriptionModule': {'briefSummary': 'This study aimed to compare the analgesia effectivity of TLIP and modified TLIP block in Posterior Lumbar Decompression and Stabilization Surgery Perioperatively.', 'detailedDescription': 'This study aimed to compare the analgesia effectivity of TLIP and modified TLIP block in Posterior Lumbar Decompression and Stabilization Surgery. Intraoperatively, total fentanyl consumption, hemodynamic, and mean qNox Score was recorded. And Postoperatively, the patient was given the PCA, and total morphine consumption was assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients undergo thoracolumbar Decompression and Stabilization Surgery\n2. Age between 18-65 years old\n3. BMI \\>18,5 kg.m2, and BMI\\< 30 kg/m2\n4. ASA 1-3\n5. No contraindications for the patients to do the Block, and the patients agree and signed the informed consent before the procedure was done\n\nExclusion Criteria:\n\n1. Obese patient, with BMI\\>30 kg.m2\n2. Alergic to local anesthetics\n3. Underweight patient with BMI \\<18,5 kg/m2"'}, 'identificationModule': {'nctId': 'NCT05104203', 'briefTitle': 'TLIP Block Versus Modified TLIP Block for Posterior Decompression and Stabilization Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Perioperative Analgesia Efectivity of Thoracolumbar Interfascial Plane Block Compared Modified Thoracolumbar Interfascial Plane Block in Posterior Lumbal Decompression and Stabilization: Research in Intraoperative Hemodynamic and qNox and Total Morfin Comsumption and Postoperative IL-6 Concentration', 'orgStudyIdInfo': {'id': 'IndonesiaUAnes111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Thoracolumbar Interfascial Plane block', 'description': 'Patient will receive Thoracolumbar Interfascial Plane block', 'interventionNames': ['Procedure: Thoracolumbar Interfascial Plane block', 'Procedure: Modified Thorcolumbar Interfascial Plane block']}, {'type': 'EXPERIMENTAL', 'label': 'Modified Thoracolumbar Interfascial Plane block', 'description': 'Patient will receive modified Thoracolumbar Interfascial Plane Block', 'interventionNames': ['Procedure: Thoracolumbar Interfascial Plane block', 'Procedure: Modified Thorcolumbar Interfascial Plane block']}], 'interventions': [{'name': 'Thoracolumbar Interfascial Plane block', 'type': 'PROCEDURE', 'description': 'Interfascial block done by injection between m. multifidus and m. longissimus', 'armGroupLabels': ['Modified Thoracolumbar Interfascial Plane block', 'Thoracolumbar Interfascial Plane block']}, {'name': 'Modified Thorcolumbar Interfascial Plane block', 'type': 'PROCEDURE', 'description': 'Injection of local anesthetics between m. longissimus and m. illiocostalis', 'armGroupLabels': ['Modified Thoracolumbar Interfascial Plane block', 'Thoracolumbar Interfascial Plane block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Cipto Mangunkusumo Cental National Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Aida Rosita Tantri', 'investigatorAffiliation': 'Indonesia University'}}}}