Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-31 @ 8:07 PM
Study NCT ID:
NCT05904912
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2023-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PENG Block forTranscatheter Aortic Valve Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D001018', 'term': 'Aortic Diseases'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes Assessor and participant will be blinded to the study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Sixty patients aged 20-95 years old with American Society of Anesthesiologists (ASA) classification I-IV and scheduled for TAVI will be included in the study. Patients will be randomly divided into two groups (Group PENG = PENG block group, Group Control = local infiltration group) including 30 patients each, before entering the operating room.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2023-05-26', 'studyFirstSubmitQcDate': '2023-06-14', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The need for fentanyl during the procedure', 'timeFrame': 'Intraoperative period', 'description': 'Intraoperative additional fentanyl need and dosage will be recorded'}], 'secondaryOutcomes': [{'measure': 'Quadriceps muscle strength', 'timeFrame': 'Postoperative 24 hours period', 'description': 'Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the Oxford muscle strength rating'}, {'measure': 'The use of rescue analgesia', 'timeFrame': 'Postoperative 24 hours period]', 'description': 'Meperidine using'}, {'measure': 'Pain scores (Numerical Rating Scale-NRS)', 'timeFrame': 'Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hours', 'description': 'Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aortic valve stenosis', 'Transcatheter aortic valv implantation (TAVI)', 'PENG block', 'Postoperative analgesia management'], 'conditions': ['Aortic Valve Stenosis', 'Aortic Diseases']}, 'referencesModule': {'references': [{'pmid': '24258463', 'type': 'BACKGROUND', 'citation': 'Clayton B, Morgan-Hughes G, Roobottom C. Transcatheter aortic valve insertion (TAVI): a review. Br J Radiol. 2014 Jan;87(1033):20130595. doi: 10.1259/bjr.20130595. Epub 2013 Nov 20.'}, {'pmid': '30063657', 'type': 'BACKGROUND', 'citation': 'Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.'}, {'pmid': '31212123', 'type': 'BACKGROUND', 'citation': 'Ahiskalioglu A, Aydin ME, Ahiskalioglu EO, Tuncer K, Celik M. Pericapsular nerve group (PENG) block for surgical anesthesia of medial thigh. J Clin Anesth. 2020 Feb;59:42-43. doi: 10.1016/j.jclinane.2019.06.021. Epub 2019 Jun 15. No abstract available.'}, {'pmid': '34175637', 'type': 'BACKGROUND', 'citation': 'Ciftci B, Ahiskalioglu A, Altintas HM, Tekin B, Sakul BU, Alici HA. A possible mechanism of motor blockade of high volume pericapsular nerve group (PENG) block: A cadaveric study. J Clin Anesth. 2021 Nov;74:110407. doi: 10.1016/j.jclinane.2021.110407. Epub 2021 Jun 24. No abstract available.'}, {'pmid': '41284052', 'type': 'DERIVED', 'citation': 'Gul YG, Alver S, Ozen V, Golboyu BE, Ciftci B. Pericapsular nerve group block reduces fentanyl use in transcatheter aortic valve implantation: a randomized prospective study. Clin Res Cardiol. 2025 Nov 24. doi: 10.1007/s00392-025-02815-0. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'Pericapsular nerve group (PENG block) is a new fascial block defined by Arango et al. This block aims to block the femoral nerve and the accessory obturator nerve by injecting local anesthetic between the pubic ramus and psoas tendon. By blocking these nerves, anterior hip analgesia is created. It is a safe and effective method as it is applied superficially and under ultrasound guidance. In radiological and cadaver studies, it has been reported that when high volume is applied, total hip analgesia can be achieved by blocking the lateral femoral cutaneous, genitofemoral, obturator, and femoral nerves.', 'detailedDescription': 'Aortic valve stenosis (AS) is the most common valve pathology, affecting 2% to 4% of patients over the age of 75. Surgical aortic valve replacement (SAVR) has been accepted as a class I recommendation for the treatment of AS for decades. However, given that advanced age, frailty, and significant comorbidities are increasingly common in affected patients; More than one-third of high-risk and severely symptomatic AS patients are physiologically unsuitable for major surgery. This is the development and implementation of TAVI, an appropriate intervention for high-risk patients and those deemed unsuitable for surgery. With a shift in the clinical paradigm towards minimally invasive procedures, the development of TAVI has revolutionized clinical outcomes in AS, particularly in those once considered inoperable.\n\nSelective candidate criteria and advances in operative techniques within TAVI are major contributors to successful outcomes. Basically, there are both retrograde and anterograde operative approaches that can be adopted within a TAVI procedure. While the transfemoral approach remains the most widely used, others include the transapical, transaxillary, transported, and transaortic pathways. The choice of technique adopted is greatly influenced by patient-related factors such as anatomical considerations and comorbidities present.\n\nBecause of the increasing use of ultrasound (US) in anesthesia practice, nerve blocks with US guidance are widely used. Pericapsular nerve group (PENG block) is a new fascial block defined by Arango et al. This block aims to block the femoral nerve and the accessory obturator nerve by injecting local anesthetic between the pubic ramus and psoas tendon. By blocking these nerves, anterior hip analgesia is created. It is a safe and effective method as it is applied superficially and under ultrasound guidance. In radiological and cadaver studies, it has been reported that when high volume is applied, total hip analgesia can be achieved by blocking the lateral femoral cutaneous, genitofemoral, obturator, and femoral nerves.\n\nThis prospective, randomized study, it was aimed to evaluate the efficacy of the PENG block for the management of analgesia during and after the procedure in patients undergoing TAVI. Our primary aim is to evaluate pain scores (Numerical Rating Scale-NRS), our secondary aim is to evaluate the amount of additional sedation intraoperatively, the degree of quadriceps motor block (paresis or paralysis in knee extension), and opioid-related side effects (allergic reaction, nausea, vomiting, etc.).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with ASA classification I-III,\n* Aged 20-80 years\n* Who will be scheduled for TAVI.\n\nExclusion Criteria:\n\n* Patients who have a history of bleeding diathesis,\n* Take anticoagulant therapy,\n* History of chronic pain before surgery,\n* Multiple trauma,\n* Who cannot assess their pain (dementia),\n* Who have been operated under spinal or epidural anesthesia,\n* Who have an infection in the area and do not accept the procedure'}, 'identificationModule': {'nctId': 'NCT05904912', 'briefTitle': 'PENG Block forTranscatheter Aortic Valve Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Evaluation of the Effect of Ultrasound-guided PENG Block on Postoperative Analgesia Management in Patients Undergoing Transcatheter Aortic Valve Implantation: A Randomized, Prospective Study', 'orgStudyIdInfo': {'id': 'Medipol Hospital 32'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group PENG = PENG block', 'description': 'PENG block will be performed', 'interventionNames': ['Drug: Postoperative analgesia management', 'Drug: PENG-Bupivacaine']}, {'type': 'OTHER', 'label': 'Group C = Control group', 'description': 'Local infiltration will be applied.', 'interventionNames': ['Drug: Postoperative analgesia management', 'Drug: Local infiltration-Bupivacaine']}], 'interventions': [{'name': 'Postoperative analgesia management', 'type': 'DRUG', 'description': 'Intravenous 0.5 mg/kg tramodol and 1 gr paracetamol will be administered to all patients 30 minutes before the end of the surgical procedure. In the postoperative period, patients will be administered iparacetamol iv 1 gr 3x1. Postoperative patient evaluation will be performed by another pain nurse who is unaware of the procedure. If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic.', 'armGroupLabels': ['Group C = Control group', 'Group PENG = PENG block']}, {'name': 'PENG-Bupivacaine', 'type': 'DRUG', 'description': 'The probe will be placed on the anterior inferior iliac crest in the transverse plane. Then, the pubic ramus will be visualized by rotating 45 degrees. The femoral artery, iliopubic process, and psoas muscle will be visualized. The needle will be punctured with the in-plane method to reach between the pubic ramus and the psoas tendon. After the block area is confirmed with 5 ml of saline, 30 ml of local anesthetic solution containing 0.25% bupivacaine will be injected.', 'armGroupLabels': ['Group PENG = PENG block']}, {'name': 'Local infiltration-Bupivacaine', 'type': 'DRUG', 'description': 'Local infiltration will be applied with 30 ml of a local anesthetic solution containing 0.25% bupivacaine by the surgical team', 'armGroupLabels': ['Group C = Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34070', 'city': 'Istanbul', 'state': 'Bagcilar', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The investigators will not share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary researcher', 'investigatorFullName': 'Bahadir Ciftci', 'investigatorAffiliation': 'Medipol University'}}}}