Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-27 @ 9:52 PM
Study NCT ID:
NCT04770961
Status:
UNKNOWN
Last Update Posted:
2021-03-03
First Post:
2021-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erector Spinae Plane Block for Minimally Invasive Mitral Valve Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}, {'id': 'D008945', 'term': 'Mitral Valve Prolapse'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016127', 'term': 'Heart Valve Prolapse'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-01', 'studyFirstSubmitDate': '2021-02-22', 'studyFirstSubmitQcDate': '2021-02-22', 'lastUpdatePostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total opiate consumption', 'timeFrame': '48 hours.', 'description': 'Total oral morphine equivalent (milligram) consumption within the first 48 hours of recovery including intra-operative usage, extracted from electronic medical record.'}], 'secondaryOutcomes': [{'measure': 'Pain score', 'timeFrame': '48 hours', 'description': 'Pain Scores will be measured on the Visual Analog Scale (VAS), the score ranges from 0-10, zero indicating no pain and 10 indicating the worst pain, assessed by nursing staff, and extracted from electronic medical record.'}, {'measure': 'Time to extubation.', 'timeFrame': 'Within 30 days from end of operation.', 'description': 'Length from ICU arrival to endotracheal extubation (minutes). If extubated in the operating room, the time will be 0 minute. Extracted from electronic medical record.'}, {'measure': 'Time to first oral intake', 'timeFrame': 'Within 30 days from end of operation.', 'description': 'Length from ICU arrival to the time of first oral intake (hours). Extracted from electronic medical record.'}, {'measure': 'Time to ambulation', 'timeFrame': 'Within 30 days from end of operation.', 'description': 'Length from ICU arrival to the time of first ambulation (hours). Extracted from electronic medical record.'}, {'measure': 'Time to chest tube removal', 'timeFrame': 'Within 30 days from end of operation.', 'description': 'Length from ICU arrival to the time of last chest tube removal (hours). Extracted from electronic medical record.'}, {'measure': 'Length of intensive care stay', 'timeFrame': 'Within 30 days from end of operation.', 'description': 'Length from ICU arrival to ICU discharge (hours). Extracted from electronic medical record.'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Within 30 days from end of operation.', 'description': 'Length from ICU arrival to hospital discharge (Hours). Extracted from electronic medical record.'}, {'measure': 'Patient self-reported experience with surgery and postoperative recovery', 'timeFrame': '30 days after hospital discharge.', 'description': "Based on questionnaires regarding the patient's experience with the efficacy of pain control and the satisfaction with postoperative recovery with scores from 1 (not satisfied at all) to 5 (very satisfied) conducted over telephone or video conferencing."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mitral valve replacement', 'mitral valve repair', 'mitral valve surgery', 'erector spinae plane', 'minimally invasive surgery'], 'conditions': ['Mitral Regurgitation', 'Mitral Valve Insufficiency', 'Mitral Valve Prolapse']}, 'descriptionModule': {'briefSummary': 'The goal of this project is to study whether local anesthetic via the erector spinae plane (ESP) block may be beneficial in minimally invasive mitral valve surgery (MIMVS).', 'detailedDescription': 'This is a double blinded randomized controlled trial comparing a control group receiving cryoablation and sham block with an intervention group receiving cryoablation and ESP catheter. The primary outcome is total oral morphine equivalent (OME) consumption within the first 48 hours of recovery including intra-operative usage. Secondary outcomes to be evaluated would include pain scores, functional milestones like time to extubation, time to first PO intake, time to ambulation, time to chest tube removal, length of ICU and total hospital stay, complications, and patient satisfaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective mitral valve repair or replacement\n* Planned minimally invasive approach\n\nExclusion Criteria:\n\n* Non-English speaking\n* Emergency surgery\n* Planned or unplanned sternotomy\n* Previous history of sternotomy and cardiac surgery\n* Allergy to ropivacaine\n* Patients taking more than 60 OMEs per day\n* Patients with coagulopathy or taking anticoagulant with laboratory findings contraindicated for ESP catheter'}, 'identificationModule': {'nctId': 'NCT04770961', 'briefTitle': 'Erector Spinae Plane Block for Minimally Invasive Mitral Valve Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Erector Spinae Plane Block for Minimally Invasive Mitral Surgery', 'orgStudyIdInfo': {'id': '19-29298'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Cryoablation', 'description': '1\\. Cryoablation of intercostal nerves + Sham ESP catheter with saline infusion.', 'interventionNames': ['Procedure: Erector spinae plane catheter with saline']}, {'type': 'EXPERIMENTAL', 'label': 'ESP + Cryoablation', 'description': '2\\. Cryoablation of intercostal nerves + ESP catheter with local anesthetic infusion.', 'interventionNames': ['Procedure: Erector spinae plane catheter with 0.5% Ropivacaine']}], 'interventions': [{'name': 'Erector spinae plane catheter with 0.5% Ropivacaine', 'type': 'PROCEDURE', 'description': 'Ultrasound guided, right sided, ESP catheter inserted at the level of T5. 20 cc injection of 0.5% Ropivacaine is injected at the time of catheter placement. Postoperatively, a programmed intermittent bolus infusion of 0.2% Ropivacaine will be delivered via the ESP catheter.', 'armGroupLabels': ['ESP + Cryoablation']}, {'name': 'Erector spinae plane catheter with saline', 'type': 'PROCEDURE', 'otherNames': ['Sham'], 'description': 'Ultrasound guided, right sided, ESP catheter inserted at the level of T5. 20 cc injection of saline is injected at the time of catheter placement. Postoperatively, a programmed intermittent bolus infusion of saline will be delivered via the ESP catheter.', 'armGroupLabels': ['Cryoablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Wilson Cui, MD, PhD', 'role': 'CONTACT', 'email': 'wilson.cui@ucsf.edu', 'phone': '415-476-6783'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Wilson Cui, MD, PhD', 'role': 'CONTACT', 'email': 'Wilson.Cui@ucsf.edu', 'phone': '415-476-6783'}], 'overallOfficials': [{'name': 'Wilson Cui, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}