Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-17 @ 12:24 AM
Study NCT ID:
NCT04406012
Status:
COMPLETED
Last Update Posted:
2020-09-29
First Post:
2020-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Efficacy of Ultrasound Guided Paravertebral Block in Percutaneous Nephrolithotomy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Paravertebral block group and Control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-26', 'studyFirstSubmitDate': '2020-05-23', 'studyFirstSubmitQcDate': '2020-05-23', 'lastUpdatePostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient VAS scores', 'timeFrame': '24 hours', 'description': '0=no pain, 10=incredible pain'}], 'secondaryOutcomes': [{'measure': 'Patient Satisfaction scores', 'timeFrame': 'at the end of the 24 hours', 'description': '0=not satisfied, 5=very good satisfied'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain management', 'Analgesia', 'paravertebral block', 'nephrolithotomy'], 'conditions': ['Pain, Postoperative; Anesthesia, Regional']}, 'referencesModule': {'references': [{'pmid': '32993528', 'type': 'DERIVED', 'citation': 'Yaman F, Tuglu D. Analgesic efficacy of ultrasound guided paravertebral block in percutaneous nephrolithotomy patients: a randomized controlled clinical study. BMC Anesthesiol. 2020 Sep 29;20(1):250. doi: 10.1186/s12871-020-01169-6.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the analgesic effects of thoracal paravertebral block in the patients undergoing percutaneous nephrolitotomy. Paravertebral block was applied to the study group. Conventional analgesia methods were applied to the control group.', 'detailedDescription': 'Randomization was divided into two groups by using closed envelope method. Postoperative pain scores at rest at 1, 2, 4, 6, 8, 10, 12, and 24 hours with VAS (0 = no pain, very severe pain = 10) using Visual Analogue Scale was made. VAS at rest and movement (coughing and taking a deep Breath) were evaluated. Patients with VAS\\> 4 received additional analgesics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'ASA I, II, III patients aged 18-65 who consented to undergo unilateral percutaneous nephrolithotomy were eligible for the study. 53 patients were eligible and assesed.Informed consent was signed by all patients. Patients under 18 years of age, pregnant, with known hypersensitivity to local anesthetics, bleeding diathesis, depression and / or anxiety disorder, obesity (BMI\\> 35kg / m2), history of pneumothorax, phrenic nerve paralysis, severe aortic stenosis were excluded. Also who did not want to participate the study.'}, 'identificationModule': {'nctId': 'NCT04406012', 'briefTitle': 'Analgesic Efficacy of Ultrasound Guided Paravertebral Block in Percutaneous Nephrolithotomy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Eskisehir Osmangazi University'}, 'officialTitle': 'Analgesic Efficacy of Ultrasound Guided Paravertebral Block in Percutaneous Nephrolithotomy Patients: A Randomized Controlled Clinical Study', 'orgStudyIdInfo': {'id': 'Eskisehir University'}, 'secondaryIdInfos': [{'id': 'Kırıkkale University', 'type': 'OTHER', 'domain': 'No:04/03'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'block group', 'description': 'Paravertebral group at Thoracic 9-10 vertebrae level with an in-plane technique advanced ultrasound guided 10 ml bupivacaine hydrochloride (Marcaine 0.5%, Astra Zeneca) in 20 ml volume was enjected in the paravertebral area with real-time visualisation It was observed that the local anesthetic drug spread on the pleura and the pleura was pushed. All blocks were performed by the same experienced anaesthesiologist.', 'interventionNames': ['Procedure: paravertebral block']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Conventional analgesia methods were applied to the control group. Control group was relieved by dexketoprofen 50mg intravenously. If the patient was not relieved with dexketoprofen and VAS score \\>4, tramadol 1 mg kg-1 was administered intravenously.'}], 'interventions': [{'name': 'paravertebral block', 'type': 'PROCEDURE', 'description': 'paravertebral block group', 'armGroupLabels': ['block group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'when the article published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eskisehir Osmangazi University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kırıkkale University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof. Dr.', 'investigatorFullName': 'Ferda YAMAN', 'investigatorAffiliation': 'Eskisehir Osmangazi University'}}}}