Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-29 @ 6:51 PM
Study NCT ID:
NCT05796804
Status:
COMPLETED
Last Update Posted:
2024-07-30
First Post:
2023-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erector Spinae Block Versus PENG Block for Hip Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000775', 'term': 'Anesthesia, Spinal'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-27', 'studyFirstSubmitDate': '2023-03-21', 'studyFirstSubmitQcDate': '2023-03-21', 'lastUpdatePostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morphine consumption', 'timeFrame': '24 hours', 'description': 'milligrams of morphine by patient controlled analgesia intravenously'}], 'secondaryOutcomes': [{'measure': 'postoperative pain', 'timeFrame': '48 hours', 'description': 'numeric rating scale - NRS 11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"'}, {'measure': 'neuropathic pain', 'timeFrame': '48 hours', 'description': 'DN4 questionnaire - 4 items questionnaire to investigate the occurrence of neuropathic component'}, {'measure': 'postoperative complications', 'timeFrame': '48 hours', 'description': 'nausea, vomiting, vertigo, blurred vision, syncope, bleeding, falls'}, {'measure': 'chronic postoperative pain', 'timeFrame': '3 months', 'description': 'numeric rating scale 11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'THR (Total Hip Replacement) can be very painful and regional anesthesia is very effective in reducing postoperative pain. Erector Spinae Plane Block (ESPB) and PENG (pericapsular nerve group block) are alternative approaches to the hip sensitive nerve branches that resulted to be very promising for hip surgeries. However, no studies investigated the analgesic superiority of either PENG or ESPB. In our study the investigators compare PENG (with a lateral femoral cutaneous nerve block) and ESPB in terms of pain relief expressed as morphine consumption in the first 24 hours after primary THR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary total hip replacement\n* informed consent\n\nExclusion Criteria:\n\n* allergies to study drugs\n* spinal anesthesia contraindicated\n* kidney failure\n* epilepsy, psychiatric disease, neurologic deficits\n* revision surgery\n* neuropathies in the lumbar area\n* no informed consent\n* pregnancy\n* alcohol/opioid abuse\n* emergency surgery/intensive care'}, 'identificationModule': {'nctId': 'NCT05796804', 'acronym': 'PENGESP', 'briefTitle': 'Erector Spinae Block Versus PENG Block for Hip Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Papa Giovanni XXIII Hospital'}, 'officialTitle': 'Erector Spinae Block Versus PENG Block for Postoperative Analgesia After Total Hip Replacement', 'orgStudyIdInfo': {'id': '030/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ERECTOR SPINAE PLANE BLOCK', 'description': 'ultrasound guided block at L4', 'interventionNames': ['Procedure: ERECTOR SPINAE PLANE BLOCK', 'Procedure: spinal anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PERICAPSULARE NERVE GROUP AND LATERAL FEMORAL CUTANEOUS NERVE BLOCK', 'description': 'ultrasound guided block below the ileo-psoas muscle tendon, above the ilio-pectineous eminence and ultrasound guided block of lateral femoral cutaneous nerve', 'interventionNames': ['Procedure: Peng block + lateral femoral cutaneous nerve block', 'Procedure: spinal anesthesia']}], 'interventions': [{'name': 'ERECTOR SPINAE PLANE BLOCK', 'type': 'PROCEDURE', 'description': 'ULTRASOUND GUIDED - ROPIVACAINE 30 ml 0.5%', 'armGroupLabels': ['ERECTOR SPINAE PLANE BLOCK']}, {'name': 'Peng block + lateral femoral cutaneous nerve block', 'type': 'PROCEDURE', 'description': 'ULTRASOUND GUIDED - ROPIVACAINE 20 ml 0.5% + 10 ml 0.5%', 'armGroupLabels': ['PERICAPSULARE NERVE GROUP AND LATERAL FEMORAL CUTANEOUS NERVE BLOCK']}, {'name': 'spinal anesthesia', 'type': 'PROCEDURE', 'description': 'bupivacaine 0.5% 2.2 ml', 'armGroupLabels': ['ERECTOR SPINAE PLANE BLOCK', 'PERICAPSULARE NERVE GROUP AND LATERAL FEMORAL CUTANEOUS NERVE BLOCK']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24127', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'Aast Papa Giovanni Xxiii', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Papa Giovanni XXIII Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Dario Bugada', 'investigatorAffiliation': 'Papa Giovanni XXIII Hospital'}}}}