Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT03887260
Status:
UNKNOWN
Last Update Posted:
2019-03-22
First Post:
2019-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Nephrectomy/Nephron Sparing Surgery(NSS) Performed Via Lumbotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-21', 'studyFirstSubmitDate': '2019-03-11', 'studyFirstSubmitQcDate': '2019-03-21', 'lastUpdatePostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Morphine Requirements', 'timeFrame': '24 hours post surgery', 'description': 'Patient Controlled Analgesia (PCA) morphine consumption in both groups will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Intraoperative Fentanyl Requirements', 'timeFrame': 'Time of surgery.', 'description': 'Fentanyl consumption in both groups will be recorded ( ug of fentanyl given intraoperatively divided by patients weight in kg and minutes of surgery)'}, {'measure': 'Postoperative Nausea and Vomiting (PONV) PONV PONV', 'timeFrame': '24 hours post surgery', 'description': 'Postoperative nausea and vomiting will be recorded if occurred'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erector Spinae Plane Block']}, 'descriptionModule': {'briefSummary': '42 patients age of 20 to 85, (ASA) physical status I-III undergoing nephrectomy/NSS procedures via lumbotomy in 1st Department of Anesthesiology in Warsaw will be enrolled in the study. Patients will be randomised into 2 groups - patients from the first group will undergo General Anesthesia (GA) with intravenous analgesia peri-operatively, patients from the second group will receive GA plus the Erector Spinae Plane Block (ESP block) unilaterally performed under ultrasound guidance with catheter left on the side of surgery. Ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the Th7 spinous process. Three muscles will be identified superficial to the hyperechogenic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. An 8-cm 18-gauge block needle will be inserted in a cephalad-to-caudad direction until the tip gets in the interfascial plane between rhomboid major and erector spinae muscles, as evidenced by visualization of local anesthetic spreading in a linear pattern between erector spinae and the bony acoustic shadows of the transverse processes. . Patients in this group will be anesthetized with 20ml 0,25% bupivacaine + Adrenaline 1:200 000 via interfascial catheter. ESP block will be performed at the level of Th7-8 after proper positioning he patient in the sitting position before GA then standard technique of catheter application will be applied. After the surgery the elastomeric pump will be attached to the catheter with 0,125% bupivacaine with Adrenaline 1:200 000. Anaesthesia will be standardised In the both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pts undergoing nephrectomy/NSS procedures via lumbotomy in 1st Department of Anaesthesiology in Warsaw\n* Pts consented for the study prior to surgery\n* ASA 1-3\n\nExclusion Criteria:\n\n* Pts without consent for trial\n* Pts ASA 4-5\n* Coagulation abnormalities\n* Allergy to local anesthetics\n* Skin lesions in the place of needle insertion'}, 'identificationModule': {'nctId': 'NCT03887260', 'briefTitle': 'Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Nephrectomy/Nephron Sparing Surgery(NSS) Performed Via Lumbotomy', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Nephrectomy/NSS Performed Via Lumbotomy', 'orgStudyIdInfo': {'id': 'ESPblockLumbotomy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GA group', 'description': 'Patients will receive general anaesthesia for nephrectomy/NSS procedures via lumbotomy. Analgesia will be provided by titration of fentanyl during surgery. An intravenous patient controlled morphine pump will be used postoperatively.', 'interventionNames': ['Drug: Morphine PCA pump', 'Drug: Fentanyl']}, {'type': 'EXPERIMENTAL', 'label': 'ESP group', 'description': 'Patients will receive general anaesthesia with ESP block for nephrectomy/NSS procedures via lumbotomy. Catheter will be inserted in the erector spinae plane on the side of surgery. Postoperatively patients will get continuous infusion of 0,125% Bupivacaine+Adrenaline to the catheter for 24h and PCA morphine pump intravenously.', 'interventionNames': ['Drug: Morphine PCA pump', 'Procedure: ESP block', 'Drug: Fentanyl']}], 'interventions': [{'name': 'Morphine PCA pump', 'type': 'DRUG', 'description': 'Morphine given postoperatively.', 'armGroupLabels': ['ESP group', 'GA group']}, {'name': 'ESP block', 'type': 'PROCEDURE', 'otherNames': ['ESP block performed with 0,25% Marcaine+Adrenaline 1:200 000'], 'description': 'Regional anaesthesia technique performed under ultrasound guidance before surgery', 'armGroupLabels': ['ESP group']}, {'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['Fentanyl administration during surgery'], 'description': "Fentanyl administration during procedure, calculated per patient's weight and duration of surgery (minutes).", 'armGroupLabels': ['ESP group', 'GA group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-005', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Anna Roziewska', 'role': 'CONTACT', 'email': 'anna.roziewska@gmail.com', 'phone': '48606932992'}], 'facility': 'Warsaw Clinical University Center', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Anna Roziewska', 'role': 'CONTACT', 'email': 'anna.roziewska@gmail.com', 'phone': '48 606932992'}, {'name': 'Lidia Jureczko', 'role': 'CONTACT', 'email': 'jureczko@gmail.com', 'phone': '48 501054419'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'collaborators': [{'name': 'Warsaw Clinical University Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}