Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-03-06 @ 8:55 AM
Study NCT ID:
NCT05320718
Status:
COMPLETED
Last Update Posted:
2025-01-08
First Post:
2022-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesia in Minimally Invasive Direct Coronary Artery Bypass Grafting: Programmed Intermittent Bolus Infusions of Erector Spinae Plane Block Versus Paravertebral Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2022-03-21', 'studyFirstSubmitQcDate': '2022-04-02', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'pulmonary function', 'timeFrame': 'preoperative and postoperative day 1 and 3', 'description': 'parameters measured by bedside spirometer, FVC, FEV1, FEV1/VC, FEF25%, FEF50%, FEF25-75, PEF'}, {'measure': 'postoperative complications: cardiac, pulmonary, cerebral, opioid intake', 'timeFrame': '3 days postoperatively', 'description': 'incidence of severe arrhythmia, cardiac arrest, pneumonia, atelectasis, pulmonary edema, postoperative delirium, nausea, vomiting'}, {'measure': 'recovery time', 'timeFrame': 'postoperatively, up to 4 weeks', 'description': 'Time for extubation, oral intake, chest drain tube removal, discharge from ICU and discharge from hospital'}, {'measure': 'plasma cortisol', 'timeFrame': 'preoperative, 24 hours and 72 hours after operation.', 'description': 'The investigator will measure the plasma cortisol level at several time points'}, {'measure': 'C-reactive protein', 'timeFrame': 'preoperative, 24 hours and 72 hours after operation.', 'description': 'The investigator will measure the plasma C-reactive protein level at several time points'}, {'measure': 'plasma troponin T level', 'timeFrame': 'preoperative, 24 hours and 72 hours after operation.', 'description': 'The investigator will measure the plasma troponin T level at several time points'}, {'measure': "patient's satisfaction with regional analgesia", 'timeFrame': '3 day postoperatively', 'description': 'Patient overall satisfaction with regional analgesia will be assessed on a 11 point scale, 0=not satisfied at all, 10=extremely satisfied'}, {'measure': 'time to perform the block', 'timeFrame': 'immediately before surgery', 'description': 'from identify the landmark using ultrasound to catheter fixation'}, {'measure': 'CK-MB', 'timeFrame': 'preoperative, 24 hours and 72 hours after operation', 'description': 'The investigator will measure the plasma CK-MB level at several time points'}, {'measure': 'performance in activities of daily living (ADL)', 'timeFrame': '3 month and 6 month postoperatively', 'description': 'Post-operative follow-up phone calls will be used to assess performance in activities of daily living (ADL) with the Barthelindex of ADL'}], 'primaryOutcomes': [{'measure': 'pain at cough after surgery', 'timeFrame': 'postoperatively 0-3 day', 'description': 'Numerical Rating Pain Scale, where 0=No Pain (better outcome) and 10=Intractable Pain (worse outcome)'}, {'measure': 'postoperative rescue analgesic consumption', 'timeFrame': 'postoperatively 0-3 day', 'description': 'morphine equivalents'}], 'secondaryOutcomes': [{'measure': 'pain at rest after surgery', 'timeFrame': 'postoperatively 0-3 day', 'description': 'Numerical Rating Pain Scale, where 0=No Pain (better outcome) and 10=Intractable Pain (worse outcome)'}, {'measure': 'adverse events of regional block', 'timeFrame': 'Intraoperative (during and immediately after block performance)', 'description': 'local bleeding, pleural puncture, local anesthetic toxicity'}, {'measure': 'dermatome of block', 'timeFrame': 'immediately after extubation', 'description': 'loss of cold sensation (ice cubes), 3-point scale: 0 = loss of cold sensation, 1=decreased cold sensation, 2 = normal sensation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Regional Anesthesia', 'Anesthesia, Local', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '31280100', 'type': 'BACKGROUND', 'citation': 'Gurkan Y, Aksu C, Kus A, Yorukoglu UH. Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. J Clin Anesth. 2020 Feb;59:84-88. doi: 10.1016/j.jclinane.2019.06.036. Epub 2019 Jul 4.'}, {'pmid': '33032124', 'type': 'BACKGROUND', 'citation': 'Saadawi M, Layera S, Aliste J, Bravo D, Leurcharusmee P, Tran Q. Erector spinae plane block: A narrative review with systematic analysis of the evidence pertaining to clinical indications and alternative truncal blocks. J Clin Anesth. 2021 Feb;68:110063. doi: 10.1016/j.jclinane.2020.110063. Epub 2020 Oct 5.'}, {'pmid': '32502778', 'type': 'BACKGROUND', 'citation': 'Huang W, Wang W, Xie W, Chen Z, Liu Y. Erector spinae plane block for postoperative analgesia in breast and thoracic surgery: A systematic review and meta-analysis. J Clin Anesth. 2020 Nov;66:109900. doi: 10.1016/j.jclinane.2020.109900. Epub 2020 Jun 2.'}]}, 'descriptionModule': {'briefSummary': 'Paravertebral block (PVB) has been regarded as effective regimen for pain control after cardiac surgery. As a novel analgesia technique, erector spinae plane block (ESPB) has been reported to provide effective analgesia after thoracic and cardiac surgery. We hypothesized that the ESPB is non-inferior to PVB in treating pain in minimally invasive direct coronary artery bypass surgery.', 'detailedDescription': 'Minimally invasive direct coronary artery bypass grafting has recently gained with popularity in treatment of coronary artery disease. Compared with conventional approach, it has advantages of less trauma and rapid recovery, but postoperative pain is severe, which may increase the risk of cardiopulmonary complications and cause chronic pain. Therefore, perioperative analgesia is crucial in minimally invasive direct coronary artery bypass grafting.\n\nParavertebral block (PVB) has been regarded as effective regimen for pain control after cardiac surgery. As a novel analgesia technique, erector spinae plane block (ESPB) has been reported to provide effective analgesia after thoracic and cardiac surgery. We hypothesized that the ESPB is non-inferior to PVB in treating pain in minimally invasive direct coronary artery bypass surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing elective minimally invasive direct coronary artery bypass grafting\n\nExclusion Criteria:\n\n1. Contraindications to regional anesthesia (coagulopathy, infection of the skin at the site of needle puncture area, et al)\n2. Morbid obesity (body mass index \\> 35 kg/m2)\n3. Allergy to any of the study drugs\n4. Chronic opioid use or history of opioid abuse.\n5. Inability to understand pain score'}, 'identificationModule': {'nctId': 'NCT05320718', 'briefTitle': 'Analgesia in Minimally Invasive Direct Coronary Artery Bypass Grafting: Programmed Intermittent Bolus Infusions of Erector Spinae Plane Block Versus Paravertebral Block', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Comparison of Programmed Intermittent Bolus Infusions of Spinae Plane Block Versus Paravertebral Block for Analgesia in Minimally Invasive Direct Coronary Artery Bypass Grafting', 'orgStudyIdInfo': {'id': 'ESPB vs PVB for MIDCAB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'erector spinae plane block', 'description': 'A needle is inserted until the tip contacted the T5 transverse process under ultrasound guidance. After confirming the needle tip position, 20 ml of 0.5% ropivacaine was injected in the plane between the erector spinae muscles and transverse process. A catheter is inserted through the needle and then connected to a Programmed Electronic Postoperative Analgesia Pump with a programmed intermittent bolus of 10 ml ropivacaine 0.2% every 2 h after surgery', 'interventionNames': ['Drug: Ropivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'thoracic paravertebral block', 'description': 'A needle is inserted into the paravertebral space. After confirming the needle tip position, 20 ml of 0.5% ropivacaine is injected in the paravertebral space. A catheter is inserted through the needle and then connected to a Programmed Electronic Postoperative Analgesia Pump with a programmed intermittent bolus of 10 ml ropivacaine 0.2% every 2 h after surgery.', 'interventionNames': ['Drug: Ropivacaine']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'description': '20 ml of 0.5% ropivacaine as bolus and a programmed intermittent bolus of 10 ml ropivacaine 0.2% every 2 h after surgery', 'armGroupLabels': ['erector spinae plane block', 'thoracic paravertebral block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Department of Anesthesiology,Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100191', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking University Third Hosptial', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Min Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Municipal Health Commission', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Director of the Department of Anesthesiology, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Min Li', 'investigatorAffiliation': 'Peking University Third Hospital'}}}}