Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-13 @ 3:28 AM
Study NCT ID:
NCT02217267
Status:
COMPLETED
Last Update Posted:
2022-11-30
First Post:
2014-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}], 'ancestors': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-24', 'studyFirstSubmitDate': '2014-08-13', 'studyFirstSubmitQcDate': '2014-08-14', 'lastUpdatePostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Psychological effects on depression, anxiety and stress', 'timeFrame': 'at 3 month after serial lidocaine infusion', 'description': 'The psychological effect will be assessed using DASS21. Each of these domains is assessed with a separate 7-item scale. Responses to the items are summed to create scales with a total possible score of 21 points, then multiplied by two to calculate the final score. The final score can then be graded in each domain: Normal (0-4), Mild (5-6), Moderate (7-11), Severe (11-13), and Extremely Severe (14+) for depression; Normal (0-3), Mild (4-5), Moderate (6-7), Severe (8-9) and Extremely Severe (10+) for anxiety; and Normal (0-7), Mild (8-9), Moderate (10-12), Severe (13-16) and Extremely Severe (14+) for stress.'}], 'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'at 3 months after serial lidocaine infusion', 'description': 'Pain intensity (Numerical Rating Scale; from 0-10) 0 means no pain, and 10 means worst pain imaginable.'}], 'secondaryOutcomes': [{'measure': 'Quality of life using Utility score', 'timeFrame': 'at 3 month after serial lidocaine infusion', 'description': 'Quality of life will be assessed using EuroQol5D5L and reported as a utility score (0-1.0) "0" represents death, and "0.1" means full health'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Peripheral neuropathy'], 'conditions': ['Peripheral Neuropathy']}, 'referencesModule': {'references': [{'pmid': '16235318', 'type': 'RESULT', 'citation': 'Challapalli V, Tremont-Lukats IW, McNicol ED, Lau J, Carr DB. Systemic administration of local anesthetic agents to relieve neuropathic pain. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD003345. doi: 10.1002/14651858.CD003345.pub2.'}, {'pmid': '14745057', 'type': 'RESULT', 'citation': 'Attal N, Rouaud J, Brasseur L, Chauvin M, Bouhassira D. Systemic lidocaine in pain due to peripheral nerve injury and predictors of response. Neurology. 2004 Jan 27;62(2):218-25. doi: 10.1212/01.wnl.0000103237.62009.77.'}, {'pmid': '9415498', 'type': 'RESULT', 'citation': 'Kingery WS. A critical review of controlled clinical trials for peripheral neuropathic pain and complex regional pain syndromes. Pain. 1997 Nov;73(2):123-139. doi: 10.1016/S0304-3959(97)00049-3.'}, {'pmid': '8857633', 'type': 'RESULT', 'citation': 'Wallace MS, Dyck BJ, Rossi SS, Yaksh TL. Computer-controlled lidocaine infusion for the evaluation of neuropathic pain after peripheral nerve injury. Pain. 1996 Jul;66(1):69-77. doi: 10.1016/0304-3959(96)02980-6.'}], 'seeAlsoLinks': [{'url': 'http://www.si.mahidol.ac.th/th/division/sirb/', 'label': 'Siriraj Institutional Review Board'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study to evaluated Long term outcome after serial Lidocaine infusion when compared with placebo in peripheral neuropathic pain patients in acute stage (less than 6 months) at 3 months after first time of infusion', 'detailedDescription': 'Peripheral nerve injury may give rise to severe and long-lasting types of pains which are often resistant to treatment such as opioid, tricyclic antidepressant or anticonvulsant. Lidocaine infusion has been the one of intractable neuropathic pain treatment . My hypothesis the serial lidocaine infusion can adequate pain control and can prevent chronic pain (central sensitisation). Therefore, we designed this prospective, randomised, double-blind, controlled study to evaluate the efficacy of serial lidocaine infusion in peripheral neuropathic pain compared with placebo in long term outcome (at 3 month).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Peripheral neuropathic pain from peripheral nerve injury within 6 months after injury\n* Well understand to Thai language in writing or listening\n\nExclusion Criteria:\n\n* Underlying Heart disease or Arrhythmia\n* Allergy to lidocaine, Gabapentin, Carbamazepine, tramadol\n* History of epilepsy\n* History of lidocaine used\n* Underlying Psychiatric disease\n* History of drug abuse\n* Pregnancy and nursing'}, 'identificationModule': {'nctId': 'NCT02217267', 'briefTitle': 'Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain : A Pilot Study', 'orgStudyIdInfo': {'id': 'SI140/2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Normal Saline 50 ml intravenous infusion in 1 hour once a week 4 times', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine group', 'description': 'Lidocaine 3mg/kg in Normal Saline to 50 ml intravenous infusion in 1 hour once a week 4 times', 'interventionNames': ['Drug: Lidocaine']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'otherNames': ['Intravenous lidocaine'], 'description': 'Lidocaine 3 mg/kg dilute in Normal Saline to 50 ml intravenous infusion in 1 hour', 'armGroupLabels': ['Lidocaine group']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkoknoi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of medicine Siriraj Hospital Mahidol University'}], 'overallOfficials': [{'name': 'Suratsawadee Wangnamthip, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}