Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-19 @ 1:46 PM
Study NCT ID:
NCT06427551
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2024-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Volume Effect in Peng Block for Total 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': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-19', 'studyFirstSubmitDate': '2024-04-26', 'studyFirstSubmitQcDate': '2024-05-19', 'lastUpdatePostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'presence of side effects', 'timeFrame': '24 hours', 'description': 'Monitoring the onset of side effects (nausea/vomiting/hypotension/dizziness/sensitive impareiment) in every group of patients in the first 24 hours every six hours'}, {'measure': 'analgesic requirements', 'timeFrame': '24 hours', 'description': 'requirement of analgesic to control the pain, assessed every six hours'}], 'primaryOutcomes': [{'measure': 'NRS evaluation', 'timeFrame': '24h post-op', 'description': 'Evaluate pain for every volume group in the first 24 hours post surgery using the Numeric Pain Scale (NRS) assigning a numeric value between zero (no pain) and ten (the worst pain ever felt). Absence of relevant pain is considered a NRS less than three.\n\nSuccess of the block was defined as NRS≤3.'}], 'secondaryOutcomes': [{'measure': 'NRS variation in time', 'timeFrame': '24 h', 'description': 'consider variation of pain, assessed with numeric Pain scale, for each group, every six hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative', 'orthopedic surgery'], 'conditions': ['Anesthesia', 'Post Operative Pain']}, 'descriptionModule': {'briefSummary': 'This study is to investigate whether a different volume of ropivacaine, with the same prescribed dosage based on body weight, can affect block efficacy, duration and side effects in the first 24 hours postoperatively.', 'detailedDescription': 'patients were divided into 3 groups on the basis of the volume of anesthetic given to perform the block. in every patient was assessed the nrs, the side effects, if any, and the need for analgesic drugs in the first 24 hour after surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients underwent total hip replacement in elective surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I, ASA II, ASA III\n* Age≥18\n* Total hip replacement surgery in spinal anesthesia\n* Informed consent\n\nExclusion Criteria:\n\n* ASA IV\n* INR\\>1.3\n* platelet values\\<100\\*10\\^3/ml a\n* patients on anticoagulant or antiplatelet therapy\n* general anesthesia for total hip replacement surgery\n* patients on chronic opioid therapy\n* altered sensitivity or motility\n* Patients in chronic opioid therapy\n* Refuse to sign informed consent form\n* Unable to sign informed consent form\n* Know allergies to medication used for analgesia'}, 'identificationModule': {'nctId': 'NCT06427551', 'acronym': 'volupeng', 'briefTitle': 'Volume Effect in Peng Block for Total Hip Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero, Universitaria Pisana'}, 'officialTitle': 'Peng Block in Total Hip Replacement: Effects of Anesthetic Volume on Clinical Outcome and Postoperative Complications', 'orgStudyIdInfo': {'id': 'VOLUPENG'}}, 'armsInterventionsModule': {'armGroups': [{'label': '15 ml local anesthetic', 'description': 'in this group of patients the peng block was performed with 15 ml of ropivacaine, whose dose was obtained on the weight', 'interventionNames': ['Drug: Ropivacaine']}, {'label': '20 ml local anesthetic', 'description': 'in this group of patients the peng block was performed with 20 ml of ropivacaine, whose dose was obtained on the weight', 'interventionNames': ['Drug: Ropivacaine']}, {'label': '30 ml local anesthetic', 'description': 'in this group of patients the peng block was performed with 30 ml of ropivacaine, whose dose was obtained on the weight', 'interventionNames': ['Drug: Ropivacaine']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'description': "The local anesthetic was dosed on the patient's weight (50-59kg: 120mg, 60-61kg: 140mg, 70-79kg: 160mg, ≥80kg: 180mg)", 'armGroupLabels': ['15 ml local anesthetic', '20 ml local anesthetic', '30 ml local anesthetic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56124', 'city': 'Pisa', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'Edificio 3 - Azienda Ospedaliero Universitaria Pisana Cisanello', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}], 'overallOfficials': [{'name': 'manuela nicastro, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'aoupisa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero, Universitaria Pisana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Serena Ricalzone', 'investigatorAffiliation': 'Azienda Ospedaliero, Universitaria Pisana'}}}}