Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:07 PM
Study NCT ID:
NCT05975294
Status:
UNKNOWN
Last Update Posted:
2023-08-03
First Post:
2023-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Comparative Study Between Ultrasound-guided Continuous Erector Spinae Plane Block and the Use of Intravenous Patient Controlled Analgesia for Management of Pain in Patients With Multiple Fracture Ribs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-27', 'studyFirstSubmitDate': '2023-07-27', 'studyFirstSubmitQcDate': '2023-07-27', 'lastUpdatePostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• Pulmonary function to evaluate mean change in incentive spirometry volume', 'timeFrame': '1 year', 'description': 'from pretreatment then 1 h after procedure then daily for 5days including: Forced expiratory volume in one second (FEV1) ,Forced vial capaciy (FVC) and The ratio of the two volumes(FEV1/FVC) and inspiratory capacity (IC).'}, {'measure': '• VAS pain score', 'timeFrame': '1 year', 'description': 'will be calculated pretreatment then at 0, 0.5h, 1h, 2h , 3h ,6h, 12h and 24h thn daily for 5 days at rest and at movement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Fracture Ribs']}, 'referencesModule': {'references': [{'pmid': '22182865', 'type': 'BACKGROUND', 'citation': 'Truitt MS, Murry J, Amos J, Lorenzo M, Mangram A, Dunn E, Moore EE. Continuous intercostal nerve blockade for rib fractures: ready for primetime? J Trauma. 2011 Dec;71(6):1548-52; discussion 1552. doi: 10.1097/TA.0b013e31823c96e0.'}, {'pmid': '34760612', 'type': 'BACKGROUND', 'citation': 'Kumar G, Kumar Bhoi S, Sinha TP, Paul S. Erector spinae plane block for multiple rib fracture done by an Emergency Physician: A case series. Australas J Ultrasound Med. 2020 Aug 30;24(1):58-62. doi: 10.1002/ajum.12225. eCollection 2021 Feb.'}, {'pmid': '25210700', 'type': 'BACKGROUND', 'citation': 'Hwang EG, Lee Y. Effectiveness of intercostal nerve block for management of pain in rib fracture patients. J Exerc Rehabil. 2014 Aug 31;10(4):241-4. doi: 10.12965/jer.140137. eCollection 2014 Aug.'}, {'pmid': '20377552', 'type': 'BACKGROUND', 'citation': 'Picard J, Meek T. Complications of regional anaesthesia. Anaesthesia. 2010 Apr;65 Suppl 1:105-15. doi: 10.1111/j.1365-2044.2009.06205.x.'}]}, 'descriptionModule': {'briefSummary': 'Rib fractures are common after blunt injury to the chest. Present in 10% of blunt trauma admissions. Pain associated with rib fractures can result in compromise of pulmonary function causing hypoxaemia or pneumonia, which may require mechanical ventilation. Adequate relief of rib fracture pain allows the patient to breathe deeply, avoid intubation and clear secretions effectively, which will minimise the pulmonary complications .\n\nPain control is essential for not only primary pain relief but also preventing secondary complications such as atelectasis or pneumonia as well as the transition to chronic pain. Accordingly, further steps are now being taken from the conventional pain control medication and techniques by the introduction of more aggressive pain control measures .Traditional regional anaesthesia (RA) techniques such as paravertebral, intercostal and epidurals injections are resource-intensive and time-consuming, limited to single dermatomes; provide incomplete analgesia of the hemithorax; and are associated with significant potential complications such as local anaesthetic intoxication, vasovagal syncope, hemi diaphragmatic paresis and pneumothorax .\n\nThe erector spinae plane block (ESPB) is a novel fascial plane block. Its use has been documented in numerous instances with positive outcomes in controlling acute as well as chronic pain. The most popular technique was the continuous infusion through a catheter . Fascial plane blocks that can be used for rib fracture pain management are serratus anterior plane block, erector spinae plane block and the rhomboid intercostal and subserratus (RISS) block. The procedure is more simple to use with a lower incidence of complications ,less time consuming , more superficial than others so it can be used in patients on anticoagulant therapy .\n\nProviding analgesia for patients with rib fractures continues to be a management challenge. Therefore, further studies are needed comparing between different techniques to prove their efficacy in pain management'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Age 18:60 years\n\n * Patient with 2 or more unilateral rib fractures.\n * ASA 1 , ASA 2\n\nExclusion Criteria:\n\n* • patient refusal\n\n * History of chronic pain or daily use of analgesics\n * History of psychiatric disorder or inability to understand the consent form or how to use a visual analog scale (VAS) for pain measurement\n * Severe renal or hepatic dysfunction\n * Allergy to any required drug\n * Second thoracic surgery\n * Local infection at the injection site\n * Spinal deformity\n * head injury\n * lung complications related to trauma ( pneumothorax , haemothorax , lung collapse).\n * need of mechanical ventilation'}, 'identificationModule': {'nctId': 'NCT05975294', 'briefTitle': 'Prospective Comparative Study Between Ultrasound-guided Continuous Erector Spinae Plane Block and the Use of Intravenous Patient Controlled Analgesia for Management of Pain in Patients With Multiple Fracture Ribs', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Prospective Comparative Study Between Ultrasound-guided Continuous Erector Spinae Plane Block and the Use of Intravenous Patient Controlled Analgesia for Management of Pain in Patients With Multiple Fracture Ribs', 'orgStudyIdInfo': {'id': 'Soh-Med-23-07-01MD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group(E):', 'description': 'including 30 patients with multiple fracture ribs will undergo ultrasound guided continuous erector spinae plane block with abolus 0.3ml /kg of amixture 0.125% bupivicaine with fentanyl of 2 mic per ml then Infusion of 0.1 ml /kg/hr of the same mixture.', 'interventionNames': ['Drug: amixture 0.125% bupivicaine with fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group (C)', 'description': 'including 30 patients with multiple fracture ribs will be given intravenous PCA device of 100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset and normal saline at a rate of 2 ml/h.', 'interventionNames': ['Drug: 100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset']}], 'interventions': [{'name': 'amixture 0.125% bupivicaine with fentanyl', 'type': 'DRUG', 'description': 'ultrasound guided continuous erector spinae plane block with abolus 0.3ml /kg of amixture 0.125% bupivicaine with fentanyl of 2 mic per ml then Infusion of 0.1 ml /kg/hr of the same mixture.', 'armGroupLabels': ['Group(E):']}, {'name': '100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset', 'type': 'DRUG', 'description': 'PCA device of 100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset and normal saline at a rate of 2 ml/h.', 'armGroupLabels': ['Group (C)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ahmed m azmy, assistant lecutrer', 'role': 'CONTACT', 'email': 'ahmed_tosson@med.sohag.edu.eg', 'phone': '01004793896'}, {'name': 'elhdad A MOUSA, professor', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecteurer anaethesia and ICU department sohag univerisity hospital', 'investigatorFullName': 'Ahmed Mahmoud Azmy', 'investigatorAffiliation': 'Sohag University'}}}}