Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
Study NCT ID:
NCT03428633
Status:
COMPLETED
Last Update Posted:
2023-10-13
First Post:
2018-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thoracic Paravertebral Blocks in Open Nephrectomy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-12', 'studyFirstSubmitDate': '2018-02-01', 'studyFirstSubmitQcDate': '2018-02-08', 'lastUpdatePostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '48 hours', 'description': 'Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)'}, {'measure': 'Oxidative stress - lactic acid (mmol/L)', 'timeFrame': '24 hours'}, {'measure': 'Oxidative stress - superoxide dismutase (units/ml)', 'timeFrame': '24 hours'}, {'measure': 'Oxidative stress - malondialdehyde (nmol/mg protein)', 'timeFrame': '24 hours'}, {'measure': 'Oxidative stress - neutrophil gelatinase-associated lipocalin (NGAL) (ng/ml)', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': '48 hours'}, {'measure': 'Patient satisfaction', 'timeFrame': '48 hours', 'description': 'Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No'}, {'measure': 'Patient mobilization', 'timeFrame': '7 days', 'description': 'Patient reporting time of first standing to the side of the bed'}, {'measure': 'Intestinal function', 'timeFrame': '7 days', 'description': 'Time of first passing of rectal gas, reported by the patient'}, {'measure': 'Chronic pain', 'timeFrame': '6 months', 'description': 'Using of Graded Chronic Pain Scale (GCPS) Grade 0: No pain in prior 6 months Grade 1: Low Intensity - Low Disability Grade II: High Intensity Characteristic Pain Intensity - Low Disability Grade III: High Disability - Moderately Limiting Grade IV: High Disability - Severely Limiting'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nephrectomy', 'Analgesia']}, 'descriptionModule': {'briefSummary': '60 patients ASA I-III, undergoing open nephrectomy will be randomly assigned into one of two groups, namely group A (n=30), where a thoracic paravertebral block will be performed preoperatively and a paravertebral catheter for continuous and patient controlled bolus local anesthetic (ropivacaine) doses will be inserted and group B (n=30) where morphine IV will be administered at the beginning and the end of operation and postoperatively through patient controlled IV doses. NRS scores in static and dynamic conditions, complications, patient satisfaction, oxidative stress (through lactic acid, superoxide dismutase, malondialdehyde) and NGAL pre- and postoperatively, will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physical status according to American Society of Anesthesiologists (ASA) I-III\n* Patients scheduled for open nephrectomy\n\nExclusion Criteria:\n\n* Previous operation on same kidney\n* Contraindication of paravertebral block or any of the agents used in the protocol\n* BMI above 32\n* Any concurrent malignancy not cured\n* Serious psychiatric, mental and cognitive disorders\n* Block failure\n* Chronic pain\n* Severe kidney disfunction'}, 'identificationModule': {'nctId': 'NCT03428633', 'briefTitle': 'Thoracic Paravertebral Blocks in Open Nephrectomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Asklepieion Voulas General Hospital'}, 'officialTitle': 'Thoracic Paravertebral Blocks in Open Nephrectomy. A Prospective, Randomized Study of Block Efficacy and Influence on Oxidative Stress and Patient Outcome.', 'orgStudyIdInfo': {'id': 'AsklepieionVGH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Thoracic paravertebral block using ropivacaine', 'interventionNames': ['Drug: Ropivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Morphine IV', 'interventionNames': ['Drug: Morphine']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'description': 'Paravertebral block using ropivacaine preoperatively and postoperatively', 'armGroupLabels': ['Group A']}, {'name': 'Morphine', 'type': 'DRUG', 'description': 'Morphine intraoperatively and postoperatively', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16673', 'city': 'Athens', 'country': 'Greece', 'facility': 'Asklepieion Hospital of Voula', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asklepieion Voulas General Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Michail Tsagkaris', 'class': 'UNKNOWN'}, {'name': 'Chryssoula Staikou', 'class': 'UNKNOWN'}, {'name': 'Ioannis Karavokyros', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Anaesthesiologist', 'investigatorFullName': 'Alexandros Makris', 'investigatorAffiliation': 'Asklepieion Voulas General Hospital'}}}}