Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-26 @ 5:58 PM
Study NCT ID:
NCT04703634
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2021-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Ultrasound-guided Erector Spinae Block on Postoperative in Patients Undergoing Nephrectomy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'It is a single centre, randomized, prospective method comparison study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2021-01-06', 'studyFirstSubmitQcDate': '2021-01-08', 'lastUpdatePostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical Rating Scale (NRS)', 'timeFrame': '24 hours', 'description': 'Numerical Rating Scale (NRS) will be used for postoperative evaluation. NRS is a segmented digital version of the visual analog scale. Selecting an integer (0-10 integers) by a responder in (VAS). It is accepted as one dimensional-the measure of pain intensity in adults. The 11-point numerical scale ranges from "0" to "10," representing a pain ("no pain"). 10 ("as bad pain as you can imagine"), or ("the worst pain imaginable").'}], 'secondaryOutcomes': [{'measure': 'Recovery analgesia', 'timeFrame': '24 hours', 'description': 'Secondary outcome measures will be routine (paracetamol or tramadol PCA) or recovery. Analgesic use will be recorded within the first 24 hours.'}, {'measure': 'postoperative nausea and vomiting', 'timeFrame': '24 hours', 'description': 'The severity of nausea and vomiting 4-point scale (none, mild, moderate, and severe). As will be recorded by the nurses in the ward.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['erector spinae block', 'nephrectomy', 'ultrasound'], 'conditions': ['Nephrectomy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the postoperative effect of erector spinae block in patients undergoing nephrectomy that causes both visceral and somatic pain.', 'detailedDescription': 'After being informed and potential risks about the study, all patients have given written consent will undergo 24 hours screening for the analgesic effect of erector spinae block after nephrectomy. Patients meeting the criteria were randomly selected in double-blind manner 1:1 ratio to erector spiane block or not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. To undergo partial or total nephrectomy surgery\n2. To be in ASA I-II classification\n3. To be between the ages of 18-65.\n4. Not having problems that prevent erector spinae block application such as local anesthetic drug allergy, infection at the injection site, and structural anomaly.\n5. Being in good mental and psychological health\n6. To accept to participate in the study.\n\nExclusion Criteria:\n\n1. Being in ASA III or IV class with a high risk of anesthesia\n2. Being outside the age range of 18-65\n3. Having problems such as local anesthetic drug allergy, infection at the injection site, and structural anomaly prevents block application.\n4. Not being mentally and psychologically healthy\n5. Those who are allergic to the active substance, patients using antiepileptic drugs\n6. Those with severe hepatic and renal failure\n7. Those who have long-term use of nonsteroidal anti-inflammatory and opioid analgesic,\n8. Those with diabetes and other neuropathic diseases\n9. Patients who cannot use patient-controlled analgesia (PCA) device'}, 'identificationModule': {'nctId': 'NCT04703634', 'briefTitle': 'The Effect of Ultrasound-guided Erector Spinae Block on Postoperative in Patients Undergoing Nephrectomy.', 'organization': {'class': 'OTHER', 'fullName': 'Namik Kemal University'}, 'officialTitle': 'The Effect of Ultrasound-guided Erector Spinae Block on Postoperative Analgesic Consumption in Patients Undergoing Nephrectomy. Prospective Randomized Single-center Study.', 'orgStudyIdInfo': {'id': 'Interventional'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'erector spinae group', 'description': 'All blocks will be done under general anesthesia. Using a 6-10 MHz linear ultrasound (Esaote my-lab 6, Italy). With the ultrasonography device of our clinic, the side of the nephrectomy surgery will be performed with the position of the nephrectomy, and the position (lateral decubitus) is given to the patient. The thoracic 10th vertebra will be found under ultrasound guidance. After the T12 transverse protrusion is seen by sliding 3 cm laterally from the midline, 30 ml of 0.25% Bupivacaine will be injected under the erector spinae muscle above it.', 'interventionNames': ['Procedure: erector spinae block (ESP)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': 'No block transaction will be applied to this group. Only postoperative analgesia methods will be used for this group as specified in the protocol.', 'interventionNames': ['Procedure: erector spinae block (ESP)']}], 'interventions': [{'name': 'erector spinae block (ESP)', 'type': 'PROCEDURE', 'description': 'Administration of local anesthetic under the erector spinae muscle just below the transverse process of the thoracic 12th vertebra', 'armGroupLabels': ['erector spinae group', 'placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Tekirdağ', 'state': 'Süleymanpaşa', 'country': 'Turkey (Türkiye)', 'facility': 'Namık Kemal University', 'geoPoint': {'lat': 40.9781, 'lon': 27.51101}}], 'overallOfficials': [{'name': 'Ayhan ŞAHİN', 'role': 'STUDY_CHAIR', 'affiliation': 'Namık Kemal University Medicine Faculty'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'starting after 6 months publication', 'ipdSharing': 'YES', 'description': 'Participant data will be shared as much as the tasks described in the study. A meeting will be held at the end of the research, and the statistical data results will be shared. Dr. Ayhan Şahin is responsible.', 'accessCriteria': 'After publication, sharing will be made according to the journal criteria.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Namik Kemal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asistant Prof', 'investigatorFullName': 'Ayhan ŞAHİN', 'investigatorAffiliation': 'Namik Kemal University'}}}}