Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT06707558
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-29
First Post:
2024-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Italian Data Registry of Patients Undergoing Peripheral Nerve Block Performed in the Emergency Departments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2024-11-25', 'studyFirstSubmitQcDate': '2024-11-25', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minimally Clinically Important Difference', 'timeFrame': 'One hour after the end of the procedure', 'description': 'The percentage of patients, relative to the total, in whom the PNB (Peripheral Nerve Block) resulted in a reduction of at least 3 points in the VAS, defined as the MCID (Minimally Clinically Important Difference).'}], 'secondaryOutcomes': [{'measure': 'Incidence of complications', 'timeFrame': '7 days after the end of the procedure', 'description': 'The number of complications associated with the procedure, such as: presence of bleeding, pneumothorax, neurological complications, neurological complications, presence of nerve damage.'}, {'measure': 'Time of procedure', 'timeFrame': 'At the end of the procedure', 'description': 'The time required in minutes for the preparation and execution of the PNB'}, {'measure': 'Patient satisfaction', 'timeFrame': 'one hour after the end of the procedure', 'description': 'Assessment of patient satisfaction about analgesia according to a 5-point Likert scale item from 1 (very unsatisfied) to 5 (very satisfied)'}, {'measure': 'Operator satisfaction', 'timeFrame': 'After the end of the procedure', 'description': 'Assessment of satisfaction of the operator performing fracture reduction According to Likert 5-item scale from 1 (very unsatisfied) to 5 (very satisfied)'}, {'measure': 'Pain before the PNB procedure', 'timeFrame': 'Before the PNB procedure', 'description': 'Pain assessment before PNB performance, according to the VAS scale, from 0 (no pain) to 10 (worst pain possible)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Emergency', 'Point of Care Ultrasound (POCUS)', 'Anesthesia', 'Acute Pain', 'Trauma']}, 'descriptionModule': {'briefSummary': 'This data registry aim is to describe the practice of Point-of-Care Ultrasound Guided Regional Anaesthesia (POCUS-GRA) in emergency departments of nosocomial hospitals where, the organizational structure, has already provided for the implementation of peripheral nerve blocks (PNB) in common clinical practice for the treatment of acute pain due to bone fractures.', 'detailedDescription': 'Pain in emergency departments (EDs) is often inadequately treated. The consequences of inadequate treatment of pain defined as "oligoanalgesia," can have a negative impact on patient outcomes. The main reasons for this include lack of appropriate pathways, incorrect habits and aversion to opioid use. Pain is a symptom present in 78% of patients entering emergency departments, and among the main causes is trauma. A multimodal approach to pain treatment is more effective and minimizes side effects such as nausea, vomiting, and drowsiness due to the use of some drugs such as opioids. Over the past fifteen years, numerous studies have demonstrated the effectiveness of pain treatment using Point-of-Care Ultrasound Guided Regional Anaesthesia (POCUS-GRA) even outside the operating room. This data registry aim is to describe the practice of Point-of-Care Ultrasound Guided Regional Anaesthesia (POCUS-GRA) in emergency departments of nosocomial hospitals where, the organizational structure, has already provided for the implementation of peripheral nerve blocks (PNB) in common clinical practice for the treatment of acute pain due to bone fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Approximately 500 patients entering the emergency department with ≤2 trauma fractures are expected to be enrolled, who undergo PNB', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years;\n* NRS\\>3\n* Patients with traumatic fractures of ≤2 districts (radiologically confirmed (RX or CT). Districts are:\n\nChest (one hemilateral) Pelvis (one hemilateral) Femur Leg Ankle Foot Shoulder Humerus Forearm Hand/fingers\n\n\\- Presence of written informed consent to the study.\n\nExclusion Criteria:\n\n* Intubated patients\n* Patients with known dementia\n* Patients with delirium (assessed by Confusion Assessment Method)\n* Pregnant patients\n* Patients with allergies to local anesthetics\n* Patients unable to adequately communicate pain'}, 'identificationModule': {'nctId': 'NCT06707558', 'acronym': 'ED-RA', 'briefTitle': 'Italian Data Registry of Patients Undergoing Peripheral Nerve Block Performed in the Emergency Departments', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria'}, 'officialTitle': 'Italian Data Registry of Patients Undergoing Peripheral Nerve Block Performed in the Emergency Departments', 'orgStudyIdInfo': {'id': 'ASO.AnRi.24.03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients from emergency department undergoing peripheral nerve blockade (PNB)', 'description': 'Patients admitted to the emergency department with ≤2 trauma fractures who undergo peripheral nerve blockade (PNB) will be enrolled'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alessandria', 'country': 'Italy', 'contacts': [{'name': 'Clinical Trial Center', 'role': 'CONTACT', 'email': 'clinicaltrialcenter@ospedale.al.it', 'phone': '0131206893'}, {'name': 'Mirco Leo, Anesthesiologist', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Center', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}], 'centralContacts': [{'name': 'Mirco Leo, Anesthesiologist', 'role': 'CONTACT', 'email': 'mirco.leo@ospedale.al.it', 'phone': '0131208119'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}