Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-29 @ 5:16 PM
Study NCT ID:
NCT06757803
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2024-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Analgesic Effect of Retro-laminar Block Versus Paravertebral Block in Patients With Multiple Fracture Ribs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012253', 'term': 'Rib Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013898', 'term': 'Thoracic Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2024-12-26', 'studyFirstSubmitQcDate': '2024-12-26', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total post operative analgesic consumption', 'timeFrame': '48 hours', 'description': 'total analgesic consumption in 1st 48hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rib Fracture']}, 'referencesModule': {'references': [{'pmid': '19837806', 'type': 'RESULT', 'citation': 'Kotze A, Scally A, Howell S. Efficacy and safety of different techniques of paravertebral block for analgesia after thoracotomy: a systematic review and metaregression. Br J Anaesth. 2009 Nov;103(5):626-36. doi: 10.1093/bja/aep272.'}]}, 'descriptionModule': {'briefSummary': 'Rib fractures are a common injury, occurring in up to 10% of all trauma patients. Multiple rib fractures can be particularly painful and debilitating, making it difficult for patients to breathe and cough. This can lead to complications such as atelectasis, pneumonia, and respiratory failure.\n\nAdequate pain control is essential for patients with rib fractures. This can help to improve respiratory function, reduce the risk of complications, and speed up recovery.\n\nParavertebral block (PVB) is a regional anaesthetic technique that is commonly used for pain management in patients with rib fractures. It involves injecting local anaesthetics into the paravertebral space, which is a region of tissue located between the transverse processes of the vertebrae and the pleura. PVB is an effective way to block the sensory nerves that supply the thoracic region, including the ribs.\n\nHowever, PVB can be technically challenging to perform, and there is a risk of complications such as pneumothorax and pleural puncture.\n\nRetrolaminar block (RLB) is a newer regional anaesthetic technique that has been proposed as an alternative to PVB for pain management in patients with rib fractures. RLB involves injecting local anaesthetics into the retrolaminar space, which is a region of tissue located between the lamina of the vertebra and the epidural space.\n\nRLB is thought to be easier to perform than PVB, and there is a lower risk of complications. However, there is limited studies support the use of RLB for pain management in patients with rib fractures.\n\nThe primary objective of this research is to compare the analgesic efficacy of retrolaminar block (RLB) and paravertebral block (PVB) in patients with fracture ribs.\n\nSecondary objectives include:\n\n* To compare the safety of RLB and PVB\n* To compare the duration of analgesia provided by RLB and PVB', 'detailedDescription': 'Rib fractures are a common injury, occurring in up to 10% of all trauma patients. Multiple rib fractures can be particularly painful and debilitating, making it difficult for patients to breathe and cough. This can lead to complications such as atelectasis, pneumonia, and respiratory failure.\n\nAdequate pain control is essential for patients with rib fractures. This can help to improve respiratory function, reduce the risk of complications, and speed up recovery.\n\nParavertebral block (PVB) is a regional anaesthetic technique that is commonly used for pain management in patients with rib fractures. It involves injecting local anaesthetics into the paravertebral space, which is a region of tissue located between the transverse processes of the vertebrae and the pleura. PVB is an effective way to block the sensory nerves that supply the thoracic region, including the ribs.\n\nHowever, PVB can be technically challenging to perform, and there is a risk of complications such as pneumothorax and pleural puncture.\n\nRetrolaminar block (RLB) is a newer regional anaesthetic technique that has been proposed as an alternative to PVB for pain management in patients with rib fractures. RLB involves injecting local anaesthetics into the retrolaminar space, which is a region of tissue located between the lamina of the vertebra and the epidural space.\n\nRLB is thought to be easier to perform than PVB, and there is a lower risk of complications. However, there is limited studies support the use of RLB for pain management in patients with rib fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\* Age 18 years or older\n\n * American Society of Anesthesiologists (ASA) physical status I-III\n * Rib fractures, as confirmed by X-ray or computed tomography (CT) scan\n * Both sexes, males and females.\n\nExclusion Criteria:\n\n* \\*Patient refusal.\n\n * Infection at the injection site\n * Allergy to local anesthetics\n * Neurological deficit\n * Spinal deformity'}, 'identificationModule': {'nctId': 'NCT06757803', 'briefTitle': 'The Analgesic Effect of Retro-laminar Block Versus Paravertebral Block in Patients With Multiple Fracture Ribs', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Analgesic Effect of Retro-laminar Block Versus Paravertebral Block in Patients With Multiple Fracture Ribs', 'orgStudyIdInfo': {'id': 'RLB VS PVB fracture ribs'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group 1', 'description': 'patients will be subjected to rertrolaminar block', 'interventionNames': ['Procedure: rertrolaminar block']}, {'type': 'EXPERIMENTAL', 'label': 'group 2', 'description': 'patients will be subjected to paravertebral block', 'interventionNames': ['Procedure: paravertebral block']}], 'interventions': [{'name': 'rertrolaminar block', 'type': 'PROCEDURE', 'description': "Positioning\n\nThe patient is positioned in a lateral decubitus position with the affected side up. The patient's arm on the affected side is placed behind the head. The patient's spine is aligned and the shoulder is elevated to expose the paravertebral space.\n\n\\*Ultrasound imaging\n\nA high-frequency linear ultrasound probe (5-12 MHz) is placed in a paramedian sagittal plane at the desired level of block. The probe is oriented so that the transverse processes are visualized on the lateral side of the screen and the vertebral laminae are visualized on the medial side of the screen. The interlaminar space is visualized as a hypoechoic region between the laminae.\n\n\\*Needle insertion\n\nA short bevel block needle (20-22 G) is inserted through the skin at the caudal end of the ultrasound probe, aiming cephalad. The needle is advanced under real-time ultrasound guidance until the tip of the needle contacts the lamina. The needle is then slightly withdrawn and the local anesthetic is injected into t", 'armGroupLabels': ['group 1']}, {'name': 'paravertebral block', 'type': 'PROCEDURE', 'description': "* Patient Preparation\n* Place the patient in the lateral decubitus position with the side of the block facing up.\n* Position the patient's arm so that it is resting comfortably on the operating table.\n* Prepare the skin over the block site with an antiseptic solution.\n* Sterilely drape the area.\n* Ultrasound Imaging\n* Place the ultrasound probe in a transverse plane at the level of the desired block.\n* Identify the following anatomical landmarks:\n* Vertebral body\n* Transverse process\n* Pleura\n* Intercostal space\n* Needle Insertion\n\nUse a sterile ultrasound-guided needle. Insert the needle in-plane from a lateral to medial direction, aiming for the apex of the paravertebral space.\n\nThe needle should be advanced until it is just beyond the transverse process.\n\n\\*Test Aspiration\n\nAspirate to ensure that the needle is not in a blood vessel.\n\n* Local Anesthetic Injection\n* Inject the local anesthetic slowly, aspirating frequently.\n* The local anesthetic should be injected int", 'armGroupLabels': ['group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Demonstrator', 'investigatorFullName': 'Eslam Mohamed Aboelyosr', 'investigatorAffiliation': 'Assiut University'}}}}