Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2025-12-24 @ 6:39 PM
Study NCT ID:
NCT03890757
Status:
UNKNOWN
Last Update Posted:
2019-03-26
First Post:
2019-03-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serratus Anterior Plane Block , Paravertebral Block and Quality of Analgesia in Patients With Blunt Chest Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-23', 'studyFirstSubmitDate': '2019-03-17', 'studyFirstSubmitQcDate': '2019-03-23', 'lastUpdatePostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome of this study was to compare ultrasound guided serratus anterior plane block and ultrasound guided paravertebral block as regard the efficacy of analgesia in patients with blunt chest trauma with unilateral multiple rib fractures', 'timeFrame': 'VAS will be recorded before performing the technique , this will be the base line record, then it will be compared by the value of VAS 30 minutes after performing the technique and the value of VAS at 1, 3, 6,12 and 24 hours', 'description': 'pain will be assessed by the visual analogue scale(VAS)'}], 'secondaryOutcomes': [{'measure': 'total dose of rescue analgesia', 'timeFrame': 'the observation will be for 24 hours', 'description': 'Analgesic requirement in the form of 25 mg pethidin intravenously if VAS score \\>3'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia']}, 'descriptionModule': {'briefSummary': 'Pain associated with rib movement cause inability to cough and breathe deeply that leads to reduction in the tidal volume and predisposes to significant atelectasis, sputum retention, pneumonia and a reduction in functional residual capacity .These factors in turn lead to decreased lung compliance, ventilation perfusion mismatch, hypoxemia and respiratory distress. Therefore, effective pain relief remains the cornerstone of management to prevent serious respiratory complications .', 'detailedDescription': 'Thoracic paravertebral block and other regional techniques like intrapleural block and intercostal nerve blocks have variable success and high potential for local anaesthetic toxicity. Serratus anterior plane block is relatively novel technique that is less invasive, easier to perform and improve pulmonary function that reduces the incidence of pneumonia, number of ventilator days, and mortality, especially those sustaining five or more rib fractures'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aging from 20 to 70 years old. - ASA physical status status I-II\n\n\\-- Patients suffering from blunt chest trauma with unilateral multiple rib fractures.', 'genderDescription': 'adult malesandfemales', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Patients aging from 20 to 70 years old.\n\n* ASA physical status status I-II -- Patients suffering from blunt chest trauma with unilateral multiple rib fractures.\n\nExclusion Criteria:• Spinal cord injury.\n\n* Epidural or spinal cord haematoma.\n* Thoracic vertebral body fracture.\n* Spinal injury awaiting assessment.\n* Coagulopathy (platelets \\<50×109 litre-1, INR\\>1.5).\n* Local infection or sepsis.\n* Allergy to local anaesthetic.\n* Inability to position patient due to associated injuries.\n* Severe traumatic brain injury.\n* Unstable lumbar or cervical spinal fractures.\n* Hypotension.\n* Hypovolaemia'}, 'identificationModule': {'nctId': 'NCT03890757', 'briefTitle': 'Serratus Anterior Plane Block , Paravertebral Block and Quality of Analgesia in Patients With Blunt Chest Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Efficacy of Serratus Anterior Plane Block Versus Thoracic Paravertebral Block in Patients With Unilateral Multiple Rib Fractures: Comparative Randomized Study', 'orgStudyIdInfo': {'id': 'Beni-Suef University Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'serratus anteriorblock', 'description': 'Serratus plane block will be performed with the patient in the lateral position and the arm abducted. Using a high-frequency linear ultrasound probe', 'interventionNames': ['Other: ultrasound guided paravertebral or serratus anterior block']}], 'interventions': [{'name': 'ultrasound guided paravertebral or serratus anterior block', 'type': 'OTHER', 'description': 'Patients groups will be as follow:\n\nGroup (I): Serratus plane block will be performed with the patient in the lateral position and the arm abducted. Using a high-frequency linear ultrasound probe ,Group (II): thoracic paravertebral block will be performed in the sitting position. The spinal level chosen for needle insertion will be two segments below the upper most fractured rib or midway between the upper most and lowest fractured rib, 2-2.5 cm distance from the midline in the same injury site', 'armGroupLabels': ['serratus anteriorblock']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banī Suwayf', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Samaa Rashwan, MD', 'role': 'CONTACT', 'phone': '0201270159125'}], 'facility': 'Beni-Suef University Hospital', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}], 'centralContacts': [{'name': 'Samaa A Rashwan, MD', 'role': 'CONTACT', 'email': 'samakassemrashwan@gmail.com', 'phone': '020120159125'}], 'overallOfficials': [{'name': 'Samaa Rashwan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assisstant proffesor of anesthesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samaa Rashwan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Samaa Abou Alkassem Rashwan', 'investigatorFullName': 'Samaa Rashwan', 'investigatorAffiliation': 'Beni-Suef University'}}}}