Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-28 @ 1:40 PM
Study NCT ID:
NCT06073795
Status:
UNKNOWN
Last Update Posted:
2023-10-10
First Post:
2023-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasongraphy Versus Fluoroscopy in Lumber Sympathetic Block in Chronic Lower Limb Ischemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001340', 'term': 'Autonomic Nerve Block'}], 'ancestors': [{'id': 'D009407', 'term': 'Nerve Block'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003714', 'term': 'Denervation'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-03', 'studyFirstSubmitDate': '2023-10-03', 'studyFirstSubmitQcDate': '2023-10-03', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the total procedure time', 'timeFrame': 'two years', 'description': "the time from the first radiographic image for the identification of the lumbar vertebral level to the completion of the bupivacaine injection (FL group), or the time from the US probe placement on the patient's skin to the completion of the bupivacaine injection (US group)."}], 'secondaryOutcomes': [{'measure': 'success rate', 'timeFrame': 'two years', 'description': 'measured by vasodilatation which is measured by temperature difference between the limbs\n\n, imaging time, onset time for temperature rise, bone touching, frequency of needle adjustment, spread pattern of contrast medium, and procedure-related complications.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['L L Ischemia']}, 'referencesModule': {'references': [{'pmid': '36900878', 'type': 'BACKGROUND', 'citation': 'Lassandro G, Tamburrini S, Liguori C, Picchi SG, Pezzullo F, Ferrandino G, Spinetti F, Vigliotti G, Marano I, Scaglione M. Lower Limb Ischemia as Acute Onset of Primary Aortic Occlusion: CTA Imaging and Management. Int J Environ Res Public Health. 2023 Feb 22;20(5):3868. doi: 10.3390/ijerph20053868.'}, {'pmid': '35526979', 'type': 'BACKGROUND', 'citation': 'Phuphanich ME, Convery QW, Nanda U, Pangarkar S. Sympathetic Blocks for Sympathetic Pain. Phys Med Rehabil Clin N Am. 2022 May;33(2):455-474. doi: 10.1016/j.pmr.2022.02.002.'}, {'pmid': '26815268', 'type': 'BACKGROUND', 'citation': 'Awal S, Madabushi R, Agarwal A, Singla V. CRPS: Early Lumbar Sympathetic Block is Better Compared to Other Interventions. Pain Physician. 2016 Feb;19(2):E363. No abstract available.'}, {'pmid': '35234922', 'type': 'BACKGROUND', 'citation': 'Samen CDK, Sutton OM, Rice AE, Zaidi MA, Siddarthan IJ, Crimmel SD, Cohen SP. Correlation Between Temperature Rise After Sympathetic Block and Pain Relief in Patients with Complex Regional Pain Syndrome. Pain Med. 2022 Sep 30;23(10):1679-1689. doi: 10.1093/pm/pnac035.'}, {'pmid': '34079360', 'type': 'BACKGROUND', 'citation': 'Kanao-Kanda M, Kanda H, Iida T, Kikuchi S, Azuma N. Clinical Application of Laser Speckle Flowgraphy to Assess Changes in Blood Flow to the Foot After a Lumbar Sympathetic Ganglion Block: A Case Report. J Pain Res. 2021 May 26;14:1451-1456. doi: 10.2147/JPR.S305543. eCollection 2021.'}, {'pmid': '36269190', 'type': 'BACKGROUND', 'citation': 'Cohen SP, Khunsriraksakul C, Yoo Y, Parker E, Samen-Akinsiku CDK, Patel N, Cohen SJ, Yuan X, Cheng J, Moon JY. Sympathetic Blocks as a Predictor for Response to Ketamine Infusion in Patients with Complex Regional Pain Syndrome: A Multicenter Study. Pain Med. 2023 Mar 1;24(3):316-324. doi: 10.1093/pm/pnac153.'}, {'pmid': '27468672', 'type': 'BACKGROUND', 'citation': 'Hurdle MF. Ultrasound-Guided Spinal Procedures for Pain: A Review. Phys Med Rehabil Clin N Am. 2016 Aug;27(3):673-86. doi: 10.1016/j.pmr.2016.04.011.'}, {'pmid': '29189275', 'type': 'BACKGROUND', 'citation': 'Ryu JH, Lee CS, Kim YC, Lee SC, Shankar H, Moon JY. Ultrasound-Assisted Versus Fluoroscopic-Guided Lumbar Sympathetic Ganglion Block: A Prospective and Randomized Study. Anesth Analg. 2018 Apr;126(4):1362-1368. doi: 10.1213/ANE.0000000000002640.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare total procedure time and success rate between FL-guided and US-assisted LSGBs in Lower Limb Ischemic patients.', 'detailedDescription': 'Morbidity and death in acute lower limb arterial occlusion are well described. The patients often are in a debilitated state, with multiple concurrent medical comorbidities. An association with hypercoagulable phenomena (e.g., active malignancy) may explain the frequency of some of these conditions. Other conditions, however, may be directly responsible for the occlusive event itself (e.g., the association of myocardial disease and peripheral embolization) (1, 2).\n\nThe sympathetic nervous system controls many of the involuntary functions of the human body and plays a role in chronic pain conditions such as complex regional pain syndrome (CRPS) (3).\n\nAbout 20% of patients who suffered lower limb ischemic pain are not suitable for surgical intervention for various reasons. In these patients, a lumbar sympathetic ganglion block (LSGB) can be used to reduce pain, improve the walking status and activities of daily living, and may delay or avoid amputation. LSGB technique has become increasingly popular in recent decades, and several diseases are treated with LSGB, including neuropathic pain (NP), vascular pain, and erythematous extremity pain (4).\n\nAn LSGB refers to injecting drugs (local anesthetic drugs: lidocaine, ropivacaine, etc.) into the lumbar sympathetic ganglia of the corresponding segment to destroy the nerve conduction function, thereby achieving the method of treating certain diseases. The use of LSGB can destroy the innervation of sympathetic nerves on the blood vessels of the lower extremities, and the innervated blood vessels continue to expand to improve local blood circulation and nutrient supply, thereby reducing pain (5).\n\nThis block is typically performed in the prone position at the L3 level under fluoroscopic guidance. Fluoroscopy (FL)-guided LSGB has been a popular technique, as it provided great accuracy in confirming the location of needle tip or intravascular (IV) injection. However, this technique exposes patients to radiation and its success rate ranges from 67% with FL guidance to 83% with computed tomography (CT) guidance (6).\n\nUltrasound (US)-guided or assisted techniques have been introduced to the field of pain medicine in the mid- 2000s. US guidance has been shown to be associated with many advantages, including minimal radiation exposure, as well as the ability to visualize soft tissue structures and observe needle insertion and spread pattern of injectate in real time (7).\n\nAs US guidance has undergone technical advancements, its applicability expanded from peripheral blocks to deep neuraxial blocks. A recent technical description of US guidance LSGB in a patient with CRPS type I showed that the anterior fascia of the psoas muscle and the anterolateral part of vertebral body are key landmarks during the procedure (8).\n\nUS-guided LSGB in conjunction with FL, may be expected to provide real-time visualization of the needle tip location with respect to the anterior fascia of the psoas major muscle in paravertebral space with an advantage of low radiation exposure.\n\nRecently, numerous US-assisted procedures in pain medicine have been attempted, showing an advantage of low radiation exposure (8).However, only few publications relatively few sample size manipulate the comparison between FL-guided and US-assisted LSGBs in Lower Limb Ischemic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Lower Limb Ischemic patients need LSGB procedures', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Lower Limb Ischemic patients need LSGB procedures\n\nExclusion Criteria:\n\n* • A body mass index (BMI) of \\>30 kg/m2.\n\n * A history of post-lumbar laminectomy with internal fixation or any severe anatomic variation, such as scoliosis and tumor.\n * History of lumbar sympathetic chemical or thermal neurolysis.\n * Pregnancy.\n * Infection at the puncture site.\n * Coagulopathy.\n * Allergy to local anesthetics.'}, 'identificationModule': {'nctId': 'NCT06073795', 'briefTitle': 'Ultrasongraphy Versus Fluoroscopy in Lumber Sympathetic Block in Chronic Lower Limb Ischemia', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Ultrasound Guided Versus Fluoroscopy Guided Lumber Sympathetic Block in Chronic Lower Limb Ischemia', 'orgStudyIdInfo': {'id': 'sympathetic block in ischemia'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FL group', 'description': 'Patients will receive FL-guided LSGB with 10 mL of 0.25% bupivacaine.', 'interventionNames': ['Procedure: sympathetic block']}, {'label': 'US group', 'description': 'Patients will receive US-assisted LSGB with 10 mL of 0.25% bupivacaine.', 'interventionNames': ['Procedure: sympathetic block']}], 'interventions': [{'name': 'sympathetic block', 'type': 'PROCEDURE', 'description': 'LSGBs will be performed at the lower third of the L2 or the upper third of the L3 vertebra without any premedication. The targeted lumbar vertebra will be identified with an anteroposterior (AP) fluoroscopic imaging in the FL group or with an US longitudinal tracing approach from the caudad to cephalad direction in the US group. The skin entry point will be infiltrated with 1% lidocaine. Then, a curved 21 G, 15-cm Chiba needle will be advanced toward the target using the posterolateral approach in both groups. Each patient will undergo LSGBs according to the allocated group.', 'armGroupLabels': ['FL group', 'US group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'sally emam, assistant lecturer', 'role': 'CONTACT', 'email': 'sallyahmed720@gmail.com', 'phone': '01068668302'}, {'name': 'mohamed bakri, professor', 'role': 'CONTACT', 'email': 'mhbakri@aun.edu.eg', 'phone': '01066356375'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Sally Ahmed kamel', 'investigatorAffiliation': 'Assiut University'}}}}