Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-03-14 @ 4:04 AM
Study NCT ID:
NCT06516432
Status:
RECRUITING
Last Update Posted:
2024-07-24
First Post:
2024-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parasternal Blockade and Serum Lactate in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be classified into a case group with parasternal block and a control group without parasternal block, with a ratio of cases to controls of 1:1.\n\nIn the case-control groups, patients with elevated serum lactate levels above 2 mmol/L and those who remained below this limit will be identified.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-18', 'studyFirstSubmitDate': '2024-07-10', 'studyFirstSubmitQcDate': '2024-07-18', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum lactate measurement', 'timeFrame': '24 hours postoperative', 'description': 'Elevated serum lactate levels above 2 mmol/L'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parasternal block', 'Cardiac surgery', 'Serum lactate'], 'conditions': ['Elective Cardiac Surgery']}, 'referencesModule': {'references': [{'pmid': '31791558', 'type': 'BACKGROUND', 'citation': 'Liu H, Emelife PI, Prabhakar A, Moll V, Kendrick JB, Parr AT, Hyatali F, Pankaj T, Li J, Cornett EM, Urman RD, Fox CJ, Kaye AD. Regional anesthesia considerations for cardiac surgery. Best Pract Res Clin Anaesthesiol. 2019 Dec;33(4):387-406. doi: 10.1016/j.bpa.2019.07.008. Epub 2019 Jul 17.'}, {'pmid': '33990437', 'type': 'BACKGROUND', 'citation': 'Bloc S, Perot BP, Gibert H, Law Koune JD, Burg Y, Leclerc D, Vuitton AS, De La Jonquiere C, Luka M, Waldmann T, Vistarini N, Aubert S, Menager MM, Merzoug M, Naudin C, Squara P. Efficacy of parasternal block to decrease intraoperative opioid use in coronary artery bypass surgery via sternotomy: a randomized controlled trial. Reg Anesth Pain Med. 2021 Aug;46(8):671-678. doi: 10.1136/rapm-2020-102207. Epub 2021 May 14.'}, {'pmid': '38375661', 'type': 'BACKGROUND', 'citation': 'Chen Y, Li Q, Liao Y, Wang X, Zhan MY, Li YY, Liu GJ, Xiao L. Preemptive deep parasternal intercostal plane block for perioperative analgesia in coronary artery bypass grafting with sternotomy: a randomized, observer-blind, controlled study. Ann Med. 2023;55(2):2302983. doi: 10.1080/07853890.2024.2302983. Epub 2024 Feb 20.'}, {'pmid': '38148266', 'type': 'BACKGROUND', 'citation': 'Wong HMK, Chen PY, Tang GCC, Chiu SLC, Mok LYH, Au SSW, Wong RHL. Deep Parasternal Intercostal Plane Block for Intraoperative Pain Control in Cardiac Surgical Patients for Sternotomy: A Prospective Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2024 Mar;38(3):683-690. doi: 10.1053/j.jvca.2023.11.038. Epub 2023 Nov 30.'}, {'pmid': '37846438', 'type': 'BACKGROUND', 'citation': 'Li JQ, Li ZH, Dong P, Liu P, Xu YZ, Fan ZJ. Effects of parasternal intercostal block on surgical site wound infection and pain in patients undergoing cardiac surgery: A meta-analysis. Int Wound J. 2023 Oct 17;21(2):e14433. doi: 10.1111/iwj.14433. Online ahead of print.'}, {'pmid': '34926506', 'type': 'BACKGROUND', 'citation': 'Wang D, Wang S, Wu J, Le S, Xie F, Li X, Wang H, Huang X, Du X, Zhang A. Nomogram Models to Predict Postoperative Hyperlactatemia in Patients Undergoing Elective Cardiac Surgery. Front Med (Lausanne). 2021 Dec 2;8:763931. doi: 10.3389/fmed.2021.763931. eCollection 2021.'}, {'pmid': '33163386', 'type': 'BACKGROUND', 'citation': 'Yang HH, Chang JC, Jhan JY, Cheng YT, Huang YT, Chang BS, Chao SF. Prognostic value of peak lactate during cardiopulmonary bypass in adult cardiac surgeries: A retrospective cohort study. Tzu Chi Med J. 2020 Feb 27;32(4):386-391. doi: 10.4103/tcmj.tcmj_215_19. eCollection 2020 Oct-Dec.'}, {'pmid': '37215823', 'type': 'BACKGROUND', 'citation': 'Zhou Y, Yang C, Jin Z, Zhang B. Intraoperative use of cell saver devices decreases the rate of hyperlactatemia in patients undergoing cardiac surgery. Heliyon. 2023 May 4;9(5):e15999. doi: 10.1016/j.heliyon.2023.e15999. eCollection 2023 May.'}, {'pmid': '35070281', 'type': 'BACKGROUND', 'citation': 'Seghrouchni A, Atmani N, Moutakiallah Y, Belmekki A, El Bekkali Y, Houssa MA. Does severe hyperlactatemia during cardiopulmonary bypass predict a worse outcome? Ann Med Surg (Lond). 2021 Dec 21;73:103198. doi: 10.1016/j.amsu.2021.103198. eCollection 2022 Jan.'}, {'pmid': '36408617', 'type': 'BACKGROUND', 'citation': 'Demir AZ, Ozgok A, Balci E, Karaca OG, Simsek E, Gunaydin S. Preoperative ultrasound-guided bilateral thoracic erector spinae plane block within an enhanced recovery program is associated with decreased intraoperative lactate levels in cardiac surgery. Perfusion. 2024 Mar;39(2):324-333. doi: 10.1177/02676591221140754. Epub 2022 Nov 21.'}, {'pmid': '34162242', 'type': 'BACKGROUND', 'citation': 'Abadi A, Cohen R. Evaluation of an Enhanced Recovery After Surgery Protocol Including Parasternal Intercostal Nerve Block in Cardiac Surgery Requiring Sternotomy. Am Surg. 2021 Dec;87(10):1561-1564. doi: 10.1177/00031348211024638. Epub 2021 Jun 23.'}, {'pmid': '35995636', 'type': 'BACKGROUND', 'citation': 'Schiavoni L, Nenna A, Cardetta F, Pascarella G, Costa F, Chello M, Agro FE, Mattei A. Parasternal Intercostal Nerve Blocks in Patients Undergoing Cardiac Surgery: Evidence Update and Technical Considerations. J Cardiothorac Vasc Anesth. 2022 Nov;36(11):4173-4182. doi: 10.1053/j.jvca.2022.07.025. Epub 2022 Jul 24.'}, {'pmid': '32579779', 'type': 'BACKGROUND', 'citation': 'Padala SRAN, Badhe AS, Parida S, Jha AK. Comparison of preincisional and postincisional parasternal intercostal block on postoperative pain in cardiac surgery. J Card Surg. 2020 Jul;35(7):1525-1530. doi: 10.1111/jocs.14651. Epub 2020 Jun 24.'}, {'pmid': '34879822', 'type': 'BACKGROUND', 'citation': 'Miao Q, Wu DJ, Chen X, Xu M, Sun L, Guo Z, He B, Wu J. Target blood pressure management during cardiopulmonary bypass improves lactate levels after cardiac surgery: a randomized controlled trial. BMC Anesthesiol. 2021 Dec 8;21(1):309. doi: 10.1186/s12871-021-01537-w.'}, {'pmid': '31356362', 'type': 'BACKGROUND', 'citation': 'Caruso TJ, Lawrence K, Tsui BCH. Regional anesthesia for cardiac surgery. Curr Opin Anaesthesiol. 2019 Oct;32(5):674-682. doi: 10.1097/ACO.0000000000000769.'}]}, 'descriptionModule': {'briefSummary': 'Serum lactate level is a key indicator of tissue perfusion. Parasternal blockade is associated with reduced postoperative inflammatory response by inhibiting stress response, leading to better outcomes. Elevated lactate levels help identify patients at risk of postoperative morbidity and mortality. This analytical cross-sectional study evaluated the association between parasternal blockade and serum lactate levels in patients undergoing elective cardiac surgery in 2022 at Specialty Hospital CMNO. Patients with and without parasternal block were compared for changes in serum lactate levels during and after anesthesia within the first 24 hours.', 'detailedDescription': 'Background: Serum lactate level is a crucial indicator of tissue perfusion. Parasternal blockade has been related to a reduction of the postoperative inflammatory response, by inhibition of the stress response, leading to a better prognosis. Increased lactate level is a useful parameter in the identification of patients at risk of postoperative morbidity and mortality.\n\nObjective: To evaluate the association between parasternal blockade and serum lactate level in patients undergoing cardiac surgery, both trans and postanesthesia.\n\nMaterials and Methods: Analytical cross-sectional study in adult patients undergoing elective cardiac surgery during the year 2022 in Specialty Hospital CMNO, patients with and without application of parasternal block were analyzed, and it was associated with changes in serum lactate level trans and post anesthesia in the first 24 hours. Approval registration: R-2023-1301-024.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients older than 18 years\n* Either sex\n* ASA II-III\n* Patients who underwent cardiac surgery with median sternotomy and use of cardiopulmonary bypass.\n\nExclusion Criteria:\n\n* Patients with pre-existing conditions that could independently affect serum lactate levels.'}, 'identificationModule': {'nctId': 'NCT06516432', 'briefTitle': 'Parasternal Blockade and Serum Lactate in Cardiac Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Instituto Mexicano del Seguro Social'}, 'officialTitle': 'Serum Lactate in the Application of Parasternal Blockade in Trans and Post Anesthetic Stages in Cardiac Surgery', 'orgStudyIdInfo': {'id': 'Parasternal Blockade 2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Case group', 'description': 'with parasternal block', 'interventionNames': ['Procedure: Parasternal block', 'Procedure: Requirement of total dose regarding fentanyl']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'without parasternal block'}], 'interventions': [{'name': 'Parasternal block', 'type': 'PROCEDURE', 'description': 'In the case-control groups, patients with elevated serum lactate levels above 2 mmol/L and those who remained below this limit will be identified.', 'armGroupLabels': ['Case group']}, {'name': 'Requirement of total dose regarding fentanyl', 'type': 'PROCEDURE', 'description': 'In case-control groups, obtain measurement of total postoperative fentanyl requirement.', 'armGroupLabels': ['Case group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44329', 'city': 'Guadalajara', 'state': 'Jalisco', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Alejandro González Ojeda, PhD', 'role': 'CONTACT', 'email': 'avygail5@gmail.com', 'phone': '3336683000'}], 'facility': 'Centro Médico Nacional de Occidente', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'centralContacts': [{'name': 'Alejandro Gonzalez, 3', 'role': 'CONTACT', 'email': 'avygail5@gmail.com', 'phone': '3331294165'}, {'name': 'Clotilde Fuentes, 1', 'role': 'CONTACT', 'email': 'clotilde.fuentes@gmail.com', 'phone': '3331154287'}], 'overallOfficials': [{'name': 'Alejandro Gonzalez, 3', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IMSS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Mexicano del Seguro Social', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'GONZALEZ-OJEDA ALEJANDRO', 'investigatorAffiliation': 'Instituto Mexicano del Seguro Social'}}}}