Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-01 @ 8:18 AM
Study NCT ID:
NCT04215757
Status:
UNKNOWN
Last Update Posted:
2020-01-02
First Post:
2019-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Lignocaine Injections as a Treatment Option for Acute Lumbosacral Radiculopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-30', 'studyFirstSubmitDate': '2019-12-30', 'studyFirstSubmitQcDate': '2019-12-30', 'lastUpdatePostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '≥50% or ≥4 point reduction in an 10-point numeric scale (NRS) at, 1 month, 2 months and 3 months.', 'timeFrame': '3 months', 'description': 'change in pain intensity measured with numeric scale.Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an ten-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Acute']}, 'referencesModule': {'references': [{'pmid': '22806363', 'type': 'RESULT', 'citation': 'Levinson SR, Luo S, Henry MA. The role of sodium channels in chronic pain. Muscle Nerve. 2012 Aug;46(2):155-65. doi: 10.1002/mus.23314.'}]}, 'descriptionModule': {'briefSummary': 'Low back pain is one of the most common ailments that plagues patients, with nearly 80% of the population developing some form of back pain in their lifetime. Up regulated sodium channels in the nerve root or dorsal root ganglion are the basic cause for the mechano-sensitization and injecting the drug in the peripheral end of the nerve will block these sodium channels, since functionally both ends of the pseudo unipolar neuron are the same.', 'detailedDescription': 'Low back pain is one of the most common ailments that plague patients, with nearly 80% of the population developing some form of back pain in their lifetime. Of all the causes of low back pain, the most common is lumbar radicular pain which may result from irritation of the nerve fibers or dorsal root ganglia due to intervertebral disc prolapse, degenerative spondylolisthesis or spinal canal stenosis. \\[1\\] Up regulated sodium channels in the nerve root or dorsal root ganglion are the basic cause for the mechano-sensitization and injecting the drug in the peripheral end of the nerve will block these sodium channels, since functionally both ends of the pseudo unipolar neuron are the same. \\[2\\]There have yet been no studies done to prove the efficacy of peripheral nerve block as an alternative to lumbar epidurals. We would like to share our experience of peripheral nerve blocks with low dose local Anaesthetics as the treatment of acute lumbosacral radiculopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 years to 60 years\n* Pain involving up to two segmental levels (L4, L5 and S1).\n* Average pain score of ≥5 on an 11-point NRS.\n* Tenderness over the concordant peripheral nerves (Gore sign +)\n* Computed tomography/Magnetic resonance imaging evidence of nerve root pain concordant with the side and level of clinical features.\n\nExclusion Criteria:\n\n* Coagulopathy and/or patients on anticoagulants.\n* Infection at the site of injection.\n* Hypersensitivity to a local anaesthetic agent.\n* Evidence of significant sensory or progressive motor deficit.\n* Presence of cancer as a cause of back pain.\n* History of previous backs surgery/epidural steroid injection.'}, 'identificationModule': {'nctId': 'NCT04215757', 'briefTitle': 'Low Dose Lignocaine Injections as a Treatment Option for Acute Lumbosacral Radiculopathy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'All India Institute of Medical Sciences, Rishikesh'}, 'officialTitle': 'PERIPHERAL NERVE BLOCKS WITH LOW DOSE LIGNOCAINE FOR THE TREATMENT OF ACUTE LUMBOSACRAL RADICULOPATHY', 'orgStudyIdInfo': {'id': '13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Patient received one or two peripheral nerve blocks at a maximum according to their involvement in the operation theatre, with full ASA monitoring under all aseptic precautions.\n\nFor L4 radiculopathy Saphenous nerve block with 1.5ml of 2% lignocaine diluted to 10ml (0.3%) For L5 radiculopathy Deep peroneal nerve block/posterior tibial nerve block with 1.5ml of 2% lignocaine diluted to 10ml (0.3%) For S1 radiculopathy Sural nerve block with 1.5ml of 2% lignocaine diluted to 10ml (0.3%)', 'interventionNames': ['Procedure: peripheral nerve block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Patients received one or two peripheral nerve blocks at a maximum according to their involvement in the operation theatre, with full ASA monitoring under all aseptic precautions.\n\nFor L4 radiculopathy Saphenous nerve block with 10ml distilled water For L5 radiculopathy Deep peroneal nerve block/posterior tibial nerve block with 10ml distilled water For S1 radiculopathy Sural nerve block with10ml distilled water', 'interventionNames': ['Procedure: peripheral nerve block']}], 'interventions': [{'name': 'peripheral nerve block', 'type': 'PROCEDURE', 'description': 'peripheral nerve blocks with low dose lignocaine in acute radiculopathy', 'armGroupLabels': ['Control group', 'Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '249203', 'city': 'Rishikesh', 'state': 'Uttarakhand', 'status': 'RECRUITING', 'country': 'India', 'facility': 'AIIMS', 'geoPoint': {'lat': 30.10778, 'lon': 78.29255}}], 'centralContacts': [{'name': 'AJIT KUMAR, MD', 'role': 'CONTACT', 'email': 'ajitdr.ajit@gmail.com', 'phone': '9910789377'}], 'overallOfficials': [{'name': 'Vijay Adabala, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AIIMS Rishikesh'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': '6 months', 'ipdSharing': 'YES', 'description': 'once the study is finished', 'accessCriteria': 'on web'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'All India Institute of Medical Sciences, Rishikesh', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'ADABALA VIJAY BABU', 'investigatorAffiliation': 'All India Institute of Medical Sciences, Rishikesh'}}}}