Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT04306133
Status:
COMPLETED
Last Update Posted:
2021-04-06
First Post:
2020-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PENG Block Combined to Wound Infiltration for Hip Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-05', 'studyFirstSubmitDate': '2020-03-08', 'studyFirstSubmitQcDate': '2020-03-10', 'lastUpdatePostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Pain Score', 'timeFrame': '24 hours', 'description': 'A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \\[100-mm scale\\]) will be used to evaluate pain during 48 h after surgery'}, {'measure': 'Total opioids consumption', 'timeFrame': '48 hours', 'description': 'Total of Sublingual Sufentanil tablets released'}], 'secondaryOutcomes': [{'measure': 'Time to first opioid', 'timeFrame': '48 hours', 'description': 'Time (hours) from the end of surgery to the first opioid administration'}, {'measure': 'Range of hip motion', 'timeFrame': '24 hours', 'description': 'Degrees of hip flexion'}, {'measure': 'Time to ambulation', 'timeFrame': '48 hours', 'description': 'Time until the patient is able to stand up and walk with or without assistive devices'}, {'measure': 'Quadriceps weakness', 'timeFrame': '48 hours', 'description': 'Presence of weakness of the quadriceps using a scale where 0= no effect; 1 = knee flexion possible but not hip flexion; 2 = absence of knee and hip flexion'}, {'measure': 'Incidence of block complications', 'timeFrame': '48 hours', 'description': 'Any complications or side effects of the blocks, such as local infection, intravascular injection of local anesthetics and immediate systemic toxicity.'}, {'measure': 'Opioids side effects', 'timeFrame': '48 hours', 'description': 'The presence or absence of opioids side effects such as drowsiness, desaturation, nausea and vomiting'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['regional anesthesia', 'hip surgery', 'PENG'], 'conditions': ['Postoperative Pain', 'Analgesia', 'Hip Arthropathy', 'Acute Pain', 'Pain', 'Postoperative Complications']}, 'referencesModule': {'references': [{'pmid': '29140962', 'type': 'BACKGROUND', 'citation': 'Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.'}, {'pmid': '30063657', 'type': 'RESULT', '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': '34196965', 'type': 'DERIVED', 'citation': 'Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.'}]}, 'descriptionModule': {'briefSummary': 'This study analyze the effect of Pericapsular Nerve Group (PENG) Block combined to wound infiltration for analgesia after elective hip replacement.\n\nHalf of participants will receive a PENG Block combined with wound infiltration, while the other half will receive wound infiltration alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Elective hip replacement surgery\n* ASA physical status score \\< 4\n\nExclusion Criteria:\n\n* Contraindications to regional anesthesia\n* ASA physical status score ≥ 4\n* Patient's refusal or inability to sing the informed consent\n* Pre-operatively therapy with opioids\n* Allergies to any drug provided by the study protocol"}, 'identificationModule': {'nctId': 'NCT04306133', 'briefTitle': 'PENG Block Combined to Wound Infiltration for Hip Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Campus Bio-Medico University'}, 'officialTitle': 'Pericapsular Nerve Group (PENG) Block Combined to Wound Infiltration vs. Wound Infiltration Alone for Postoperative Analgesia After Total Hip Replacement: a Prospective Controlled Trial', 'orgStudyIdInfo': {'id': '29/20 PAR ComEt CBM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PENG BLOCK AND WOUND INFILTRATION', 'description': 'Participants receiving PENG block combined to wound infiltration', 'interventionNames': ['Procedure: PENG block', 'Procedure: Wound Infiltration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'WOUND INFILTRATION', 'description': 'Participants receiving wound infiltration alone', 'interventionNames': ['Procedure: Wound Infiltration']}], 'interventions': [{'name': 'PENG block', 'type': 'PROCEDURE', 'description': 'After performing spinal anesthesia, PENG block with 20 mL of 0.375 % Ropivacaine will be executed as described by Giron-Arongo et al with a low frequency curvilinear probe. A 22G 80 mm needle (Stimuplex Ultra 360, Braun ) will be used.', 'armGroupLabels': ['PENG BLOCK AND WOUND INFILTRATION']}, {'name': 'Wound Infiltration', 'type': 'PROCEDURE', 'description': 'At the end of operation, the surgeon will perform wound infiltration with 20 mL of 0.375 % Ropivacaine.', 'armGroupLabels': ['PENG BLOCK AND WOUND INFILTRATION', 'WOUND INFILTRATION']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Roma', 'country': 'Italy', 'facility': 'Università Campus Biomedico', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Giuseppe Pascarella, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Campus Biomedico of Rome'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Campus Bio-Medico University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Giuseppe Pascarella', 'investigatorAffiliation': 'Campus Bio-Medico University'}}}}