Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-26 @ 2:16 AM
Study NCT ID:
NCT06257160
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2024-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Superiority Randomized Controlled Trial of Ultrasound-guided PENG Block Compared to Surgical Infiltration in the Analgesia of Posterior Total Hip Arthroplasty Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2024-02-06', 'studyFirstSubmitQcDate': '2024-02-06', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine consumption', 'timeFrame': 'At 24 hours postoperative'}], 'secondaryOutcomes': [{'measure': 'Pain evaluation', 'timeFrame': 'At 1 hour postoperative', 'description': 'Numeric pain intensity scale'}, {'measure': 'Pain evaluation', 'timeFrame': 'At 2 hours postoperative', 'description': 'Numeric pain intensity scale'}, {'measure': 'Pain evaluation', 'timeFrame': 'At 6 hours postoperative', 'description': 'Numeric pain intensity scale'}, {'measure': 'Pain evaluation', 'timeFrame': 'At 12 hours postoperative', 'description': 'Numeric pain intensity scale'}, {'measure': 'Pain evaluation', 'timeFrame': 'At 24 hours postoperative', 'description': 'Numeric pain intensity scale'}, {'measure': 'Pain evaluation', 'timeFrame': 'At 36 hours postoperative', 'description': 'Numeric pain intensity scale'}, {'measure': 'Pain evaluation', 'timeFrame': 'At 48 hours postoperative', 'description': 'Numeric pain intensity scale'}, {'measure': 'Success or failure at first stand up test', 'timeFrame': 'At 4 hours postoperative'}, {'measure': 'Need for analgesia rescue technique', 'timeFrame': 'At 24 hours postoperative'}, {'measure': '10 meters walk test', 'timeFrame': 'At 24 hours postoperative'}, {'measure': 'Muscle strength test', 'timeFrame': 'At 24 hours postoperative'}, {'measure': 'Length of hospital stay', 'timeFrame': 'At the end of the stay'}, {'measure': 'Adverse events due to consumption of morphine', 'timeFrame': 'At 24 hours postoperative'}, {'measure': 'Adverse events due to PENG block ou surgical infiltration', 'timeFrame': 'At 24 hours postoperative'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Analgesia', 'Hip', 'Arthroplasty', 'PENG', 'locoregional anesthesia', 'infiltration'], 'conditions': ['Hip Arthropathy', 'Hip Arthrosis']}, 'descriptionModule': {'briefSummary': "Pain after total hip replacement (THR) surgery is severe. The target population is elderly and comorbid. Level III analgesics are responsible for significant side effects in this population. Locoregional analgesia, by reducing the consumption of painkillers, is an effective way of reducing morphine or morphine agonist consumption in this surgery. Furthermore, these techniques fit in perfectly with the objectives of accelerated rehabilitation after surgery. Surgical infiltration is a frequently used and effective analgesic technique. PENG block is a new locoregional anesthesia technique which initial results show promising analgesic efficacy and the absence of loss of strength through motor block.\n\nIn February 2022, we carried out a survey of national anesthetic practices in posterior hip arthroplasty, with the help of the SFAR (Société Française d'Anesthésie-Réanimation).\n\nIt shows that, despite the lack of plentiful literature on the subject, the PENG block is currently the most frequently performed pre-operative block in hip arthroplasty (PENG block in 39.5% of cases, femoral block in 13% of cases).\n\nThe survey also shows that in 41.5% of cases, no block is performed, and only intraoperative surgical infiltration is carried out.\n\nPENG block and surgical infiltration are therefore the two analgesic techniques most frequently used in France today.\n\nIt is for these reasons that we feel it is essential to carry out a study comparing these two techniques.", 'detailedDescription': 'The aim of this study was to compare the clinical efficacy of these two locoregional analgesia strategies in posterior total hip replacement surgery: ultrasound-guided PENG block and surgical infiltration.\n\nThe study is a superiority randomized, double-blind (patient and evaluator will be blinded to the randomization group), single-center trial.\n\nTwo groups of patients will be compared: a group of patients benefiting from the echo-guided PENG block strategy, and a group of patients benefiting from intraoperative surgical infiltration.\n\nThe type of treatment (PENG block or surgical infiltration) will be randomized. The target population concerns patients scheduled for posterior total hip replacement surgery at Reims University Hospital If the hypothesis of the superior efficacy of echo-guided block PENG is confirmed, our analgesia strategy for total hip replacement surgery will be modified, enabling us to offer the most effective locoregional analgesia technique and thus reduce the morbidity and mortality associated with morphine consumption.\n\nThis could have both a medical and an economic impact, by optimizing post-operative monitoring and convalescence for these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients eligible for posterior total hip replacement surgery at Reims University Hospital\n* Patients agreeing to take part in the research and having signed the informed consent form\n* Patients of full age\n* Patients affiliated to a social security scheme\n\nExclusion criteria:\n\n* Minor patients\n* Patients protected by law\n* Pregnant and breast-feeding women\n* Patients with allergy to local anesthetics\n* Patients with neuropathy\n* Patients with an ASA score greater than or equal to 4\n* Patients undergoing revision surgery on a total hip prosthesis\n* Patients undergoing anterior total hip replacement surgery\n* Patients suffering from a femur fracture\n* Patients with a contraindication to Peng block.\n* Patients refusing one of the proposed techniques.\n* Persons deprived of their liberty by judicial or administrative decision.\n* Persons under psychiatric care\n* Persons unable to express their consent.'}, 'identificationModule': {'nctId': 'NCT06257160', 'acronym': 'PENGORINF', 'briefTitle': 'Superiority Randomized Controlled Trial of Ultrasound-guided PENG Block Compared to Surgical Infiltration in the Analgesia of Posterior Total Hip Arthroplasty Surgery', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Reims'}, 'officialTitle': 'Superiority Randomized Controlled Trial of Ultrasound-guided PENG Block Compared to Surgical Infiltration in the Analgesia of Posterior Total Hip Arthroplasty Surgery', 'orgStudyIdInfo': {'id': 'PO24003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical infiltration', 'interventionNames': ['Procedure: Surgical infiltration']}, {'type': 'EXPERIMENTAL', 'label': 'PENG Block ultrasound-guided', 'interventionNames': ['Procedure: PENG Block ultrasound-guided']}], 'interventions': [{'name': 'Surgical infiltration', 'type': 'PROCEDURE', 'description': 'During surgery, local anesthetics are injected as follow: in the deep plane and in the subcutaneous territory.\n\nInfiltration of the deep plane corresponds to pericotyloid injection, with particular attention to the posterior subcapsular area, the obturator foramen and the psoas muscle. Infiltration of the muscular planes is added, with infiltration of the gluteal and pelvitrochanteric muscles.', 'armGroupLabels': ['Surgical infiltration']}, {'name': 'PENG Block ultrasound-guided', 'type': 'PROCEDURE', 'description': 'We perform the femoral block under ultrasound after anesthesia (general or rachianesthesia). The PENG block is a peripheral diffusion nerve block that specifically targets the articular divisions of the femoral, obturator and accessory obturator nerves.\n\nThe femoral nerve innervates the four parts of the joint capsule, with inconsistency in the anterior inferomedial part of the capsule.\n\nThe obturator nerve innervates the inferior part of the anterior face of the capsule.\n\nThe accessory obturator nerve innervates the medial half of the hip joint capsule in over 50% of cases.', 'armGroupLabels': ['PENG Block ultrasound-guided']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Reims', 'country': 'France', 'facility': 'Damien JOLLY', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Reims', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}