Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-30 @ 3:49 PM
Study NCT ID:
NCT04924335
Status:
COMPLETED
Last Update Posted:
2021-08-20
First Post:
2021-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Erector Spinae Plane (ESP) Block on Surgery-related Stress Response in Cardiac Surgery With ERAS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015775', 'term': 'Fractures, Stress'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-17', 'studyFirstSubmitDate': '2021-05-22', 'studyFirstSubmitQcDate': '2021-06-06', 'lastUpdatePostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Basal measurements- after anesthesia induction', 'timeFrame': 'After anesthesia induction, an average of 5 minutes', 'description': 'After induction of anesthesia, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.'}, {'measure': 'Basal measurements- after anesthesia induction', 'timeFrame': 'After anesthesia induction, an average of 5 minutes', 'description': 'After induction of anesthesia, blood gas analysis will be performed and hemoglobin level (g/dL) will be recorded.'}, {'measure': 'Second measurements- after cardiopulmonary bypass initiation', 'timeFrame': 'After cardiopulmonary bypass inititation, an average of 5 minutes', 'description': 'After cardiopulmonary bypass initiation, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.'}, {'measure': 'Second measurements- after cardiopulmonary bypass initiation', 'timeFrame': 'After cardiopulmonary bypass inititation, an average of 5 minutes', 'description': 'After cardiopulmonary bypass initiation, blood gas analysis will be performed and hemoglobin level (g/dL) will be recorded.'}, {'measure': 'Third measurements- during cardiopulmonary bypass, at lowest temperature', 'timeFrame': 'During cardiopulmonary bypass, an average of 10 minutes', 'description': 'During cardiopulmonary bypass, at lowest temperature, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.'}, {'measure': 'Third measurements- during cardiopulmonary bypass, at lowest temperature', 'timeFrame': 'During cardiopulmonary bypass, an average of 10 minutes', 'description': 'During cardiopulmonary bypass, at lowest temperature, blood gas analysis will be performed and hemoglobin level (g/dL) will be recorded.'}, {'measure': 'Fourth measurements- end of cardiopulmonary bypass', 'timeFrame': 'At the end of cardiopulmonary bypass, an average of 10 minutes', 'description': 'At the end of cardiopulmonary bypass, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.'}, {'measure': 'Fourth measurements- end of cardiopulmonary bypass', 'timeFrame': 'At the end of cardiopulmonary bypass, an average of 10 minutes', 'description': 'At the end of cardiopulmonary bypass, blood gas analysis will be performed and hemoglobin level (g(dL) will be recorded.'}, {'measure': 'Fifth measurements- end of surgery', 'timeFrame': 'At the end of surgery, an average of 20 minutes', 'description': 'At the end of surgery, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.'}, {'measure': 'Fifth measurements- end of surgery', 'timeFrame': 'At the end of surgery, an average of 20 minutes', 'description': 'At the end of surgery, blood gas analysis will be performed and hemoglobin level (g/dL) will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Preoperative complete blood count', 'timeFrame': 'The day before surgery, 24 hours', 'description': 'Preoperative complete blood count will be evaluated and recorded.'}, {'measure': 'Preoperative albumin', 'timeFrame': 'The day before surgery, 24 hours', 'description': 'Preoperative albumin levels will be evaluated and recorded.'}, {'measure': 'Postoperative C reactive protein', 'timeFrame': '6 hours after surgery', 'description': 'Postoperative C reactive protein levels will be evaluated and recorded.'}, {'measure': 'Postoperative complete blood count', 'timeFrame': '6 hours after surgery', 'description': 'Postoperative complete blood count will be evaluated and recorded.'}, {'measure': 'Postoperative albumin', 'timeFrame': '6 hours after surgery', 'description': 'Postoperative albumin levels will be evaluated and recorded.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['erector spinae plane block', 'cardiac surgery', 'enhanced recovery after surgery program', 'lactate', 'stress response', 'c reactive protein'], 'conditions': ['Surgery Stress']}, 'descriptionModule': {'briefSummary': 'Surgery-induced pain reveals its own metabolic and inflammatory responses, resulting in a further increase in noxious pathways that are already occurring. Even though it is difficult to distinguish whether the metabolic and inflammatory responses are pain-induced or surgical-induced, it is clear that pain can cause a response. This study aims to investigate the effects of erector spinae plane block on surgery-related stress response with enhanced recovery after cardiac surgery protocol.', 'detailedDescription': "The Enhanced Recovery After Cardiac Surgery (ERAS Cardiac) program includes a perioperative multimodal, opioid-sparing pain management plan as an essential component of any comprehensive program. A multimodal pain management plan is nonopioid systemic analgesic agents, regional and local anesthetic techniques, and judicious use of opioids. This study aims to examine inflammatory and hematological parameters in patients who underwent cardiac surgery with ERAS, with and without preoperative bilateral erector spinae plane block (ESP). For this purpose, the presence of an obstacle ESP block application in the preoperative period will be investigated in patients who are prepared for cardiac surgery according to ERAS principles, and the patient's group will be determined accordingly. An analgesia protocol that does not include a regional technique will be applied to the patient in cases such as the patient's refusal to allow preoperative block and the presence of a situation that does not allow blockage in the block area. The perioperative characteristics of ERAS patients with and without ESP block will be examined, intraoperative lactate, and preop-postoperative hemogram-albumin-C reactive protein parameters will be recorded.\n\nERAS patients with ESP block: After preparation in accordance with the ERAS protocol, ultrasound-guided bilateral ESP block will be performed with 20 ml of 0.025% bupivacaine at T5-7 levels in patients taken to the operating room in the preoperative period, and will be administered intraoperative low-dose remifentanil infusion and sevoflurane anesthesia.\n\nERAS patients without ESP block: After preparation according to the ERAS protocol, patients will be administered lidocaine, ketamine, paracetamol, and intraoperative low-dose remifentanil infusion and sevoflurane anesthesia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients who will undergo open-heart surgery with ERAS protocol\n\nExclusion Criteria:\n\n* Emergency surgeries\n* Patients with allergic reactions to anesthesia and analgesia drugs to be used\n* Patients who do not want to participate in the study voluntarily\n* Severe systemic disease (kidney, liver, pulmonary, endocrine)\n* Substance abuse history\n* History of chronic pain\n* Psychiatric problems and communication difficulties\n* Patients who need revision due to hemostasis in the postoperative period\n* Patients with severe hemodynamic instability due to infection, heavy bleeding, etc.'}, 'identificationModule': {'nctId': 'NCT04924335', 'briefTitle': 'The Effects of Erector Spinae Plane (ESP) Block on Surgery-related Stress Response in Cardiac Surgery With ERAS', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Ultrasound-guided Erector Spinae Plane (ESP) Block Attenuates Surgery-related Stress Response in Cardiac Surgery Patients Undergoing Enhanced Recovery After Surgery (ERAS) Program', 'orgStudyIdInfo': {'id': 'MH2.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ESP group', 'description': 'ESP group patients will be performed ultrasound-guided erector spinae plane block with 20 ml 0.025% Bupivacaine, preoperatively and will receive ERAS cardiac anesthesia protocol', 'interventionNames': ['Procedure: Erector spinae plane block']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional group', 'description': 'The conventional group will receive ERAS cardiac anesthesia protocol'}], 'interventions': [{'name': 'Erector spinae plane block', 'type': 'PROCEDURE', 'description': 'Preoperative ultrasound-guided bilateral erector spinae plane block with 20 ml 0.025% bupivacaine.', 'armGroupLabels': ['ESP group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'state': 'Select State/Province', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Serdar Günaydın, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara City Hospital Bilkent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Eda Balci', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}