Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-03-23 @ 7:02 PM
Study NCT ID:
NCT06387095
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Parasternal Blocks in Cardiovascular Surgery Patients Undergoing Median Sternotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'randomized controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2024-04-24', 'lastUpdatePostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative chronic pain', 'timeFrame': '6 months', 'description': 'Determination the effect of parasternal blocks on the incidence for chronic pain at 6 months postoperative period in cardiac surgery. The s-lanss scores of the patients at the 6th postoperative month will be evaluated. The range of the questionnaire is 0-24 and patients with a score above 12 will be considered to have neuropathic pain.'}], 'secondaryOutcomes': [{'measure': 'postoperative 24 hours acute pain', 'timeFrame': '24 hours', 'description': 'postoperative 24 hours pain of the patients will be evaluated with VAS (visual analogue scale). analgesic needs of the patients in the first 24 hours postoperatively will be calculated as morphine equivalent dose using PCA device. At the end of the 24th hour, BPI (brief pain index) will be evaluated. additional analgesic needs of the patients (NSAID, narcotic), if any, will be recorded. it will be evaluated whether there is a significant difference between the VAS scores, analgesic needs and BPI scores in the first 24 hours pain according to the groups.'}, {'measure': 'extubation time', 'timeFrame': '24 hours', 'description': 'Extubation time (defined as the time from admission to intensive care unit until extubation) will be evaluated for differences between the groups.the control group'}, {'measure': 'icu time', 'timeFrame': '7 days', 'description': 'The study will look at whether intensive care and hospital discharge times differ between the groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative pain', 'parasternal blocks', 'chronic pain', 'acute pain', 'cabg'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': "Acute and chronic pain after cardiac surgery is a common problem that negatively affects quality of life. Postoperative pain after cardiac surgery is most intense in the first two days and decreases in the following period. However, postoperative pain with incomplete management in the acute period may become chronic. This may negatively affect the patient's quality of life. Although central blocks such as thoracic epidural and paravertebral blocks are considered the gold standard in analgesia control, the advantages of thoracic plan blocks, which are more superficial due to peroperative heparinisation; coagulation disorders; and procedural difficulties, are undeniable. Thoracic plane blocks, which can also be used in patients receiving anticoagulant and/or antiplatelet therapy, have recently been used for acute pain. The aim of this study was to evaluate the effect of thoracic plane blocks on extubation time, pain scores, intensive care unit (ICU) and hospital stays in patients undergoing median sternotomy.", 'detailedDescription': 'The study will proceed in three arms. The first group is the control group and will receive total intravenous anaesthesia as infusion after peroperative induction until the patient leaves the operating room. The second group will receive ultrasound-guided parasternal superficial plan block after induction. The third group will receive ultrasound-guided parasternal deep plan block. Extubation times, additional analgesic needs, pain scores, intensive care unit duration and hospital discharge times will be compared in the three groups during intensive care unit follow-up. After extubation, patient-controlled analgesia will be applied for 24 hours (with pca infusion pump device).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Performing median sternotomy\n* Elective case\n* Over 18 years of age; under 80 years of age\n* ASA II-III patients\n\nExclusion Criteria:\n\n* Emergency cases\n* Patients undergoing minimally invasive surgery\n* Patients with a history of opioid use in the last 30 days\n* Redo cases\n* Patients with left ventricular ejection fraction less than 30%\n* Patients with severe hepatic or renal insufficiency\n* Patients with chronic pain before surgery (migraine, fibromyalgia)'}, 'identificationModule': {'nctId': 'NCT06387095', 'briefTitle': 'Efficacy of Parasternal Blocks in Cardiovascular Surgery Patients Undergoing Median Sternotomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital'}, 'officialTitle': 'Efficacy of Parasternal Blocks in Cardiovascular Surgery Patients Undergoing Median Sternotomy: Randomized, Controlled Study', 'orgStudyIdInfo': {'id': '2024/01/756'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1. control group', 'description': "control group. block will not be applied to this group and the patient's analgesia needs will be provided with patient-controlled analgesia devices.", 'interventionNames': ['Procedure: 1. no block']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2. superficial parasternal plane block group', 'description': 'superficial parasternal plane block group. superficial paraasternal plane block will be applied to this group. it will be applied to the parasternal region with ultrasound after the patient is intubated. patient-controlled analgesia devices will be used for additional postoperative pain needs.', 'interventionNames': ['Procedure: 2. superficial parasternal block']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3. deep parasternal plane block group', 'description': 'deep parasternal plane block group. deep paraasternal plane block will be applied to this group. it will be applied to the parasternal region with ultrasound after the patient is intubated. patient-controlled analgesia devices will be used for additional postoperative pain needs.', 'interventionNames': ['Procedure: 3. deep parasternal block']}], 'interventions': [{'name': '1. no block', 'type': 'PROCEDURE', 'otherNames': ['intravenous analgesia'], 'description': 'After extubation, patient-controlled analgesia will be applied for 24 hours (with PCA infusion pump device). During the follow-up of the patients in intensive care, extubation times, additional analgesic needs, pain scores; intensive care and hospital discharge times will be recorded.', 'armGroupLabels': ['1. control group']}, {'name': '2. superficial parasternal block', 'type': 'PROCEDURE', 'otherNames': ['intravenous analgesia', 'regional analjesia'], 'description': 'After induction, the patient will undergo an ultrasound-guided superficial parasternal plan block. . After extubation, patient-controlled analgesia will be applied for 24 hours (with PCA infusion pump device). During the follow-up of the patients in intensive care, extubation times, additional analgesic needs, pain scores; intensive care and hospital discharge times will be recorded.', 'armGroupLabels': ['2. superficial parasternal plane block group']}, {'name': '3. deep parasternal block', 'type': 'PROCEDURE', 'otherNames': ['intravenous analgesia', 'regional analjesia'], 'description': 'After induction, the patient will undergo an ultrasound-guided deep parasternal plane block. . After extubation, patient-controlled analgesia will be applied for 24 hours (with PCA infusion pump device). During the follow-up of the patients in intensive care, extubation times, additional analgesic needs, pain scores; intensive care and hospital discharge times will be recorded.', 'armGroupLabels': ['3. deep parasternal plane block group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Kartal', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'münire deniz', 'role': 'CONTACT', 'email': 'muniredeniz.md@gmail.com', 'phone': '+905556461015'}, {'name': 'ömer savluk', 'role': 'CONTACT', 'email': 'dromersavluk@hotmail.com', 'phone': '+905056877440'}], 'facility': 'Kosuyolu High Education and Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'omer savluk', 'role': 'CONTACT', 'email': 'dromersavluk@hotmail.com', 'phone': '+905056877440'}], 'overallOfficials': [{'name': 'munire deniz', 'role': 'STUDY_DIRECTOR', 'affiliation': 'kosuyolu high education and training center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator Medical Doctor', 'investigatorFullName': 'münire deniz', 'investigatorAffiliation': 'Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital'}}}}