Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:45 AM
Study NCT ID:
NCT07475520
Status:
COMPLETED
Last Update Posted:
2026-03-16
First Post:
2026-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lidocaine IV Injection With Different Doses for Patients With Neuropathic Pain After Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2025-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-08', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess neuropathic pain scale', 'timeFrame': 'assessed at 0, 15, 30, 1 hour. 2 hours and 24 hours and 1 week after injection', 'description': 'a 10-item tool designed to assess the distinct qualities (e.g., burning, freezing, stinging) and intensity of nerve-related pain, using 0-10 numerical ratings for each.This scale measures 10 specific qualities associated with neuropathic pain; 7 of the 10 pain qualities contain the words: intense, sharp, hot, dull, cold, and itchy to characterize the patient\'s pain, and the word "sensitive" describes the patient\'s pain reaction to light touch or clothing. One item describes the pain in regard to time (all the time or some of the time). The ninth item describes the overall unpleasantness of the pain, and the last item indicates the intensity of the deep and surface pain. It helps distinguish neuropathic from other pain types.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuropathic pain', 'mastectomy', 'Lidocaine'], 'conditions': ['Neuropathic Pain Induced by Mastectomy']}, 'descriptionModule': {'briefSummary': 'cancer has become the most common malignancy affecting women worldwide, and its incidence is increasing annually. According to the Global Cancer Observatory (GLOBOCAN) 2020 published by the International Agency for Research on Cancer of the World Health Organization, female breast cancer is the cancer with the highest number of new cases worldwide significant number of patients experiencing moderate to severe acute pain (30-50%) and developing chronic post-surgical pain (CPSP) (25-68%)', 'detailedDescription': "Various drugs have been used for neuropathic pain management Opioid agonists, but endocrine and immunologic alterations were reported. Concerns about an increase in opioid prescription that is associated with overdose mortality, misuse and other opioid related morbidity resulted in tracking daily doses and monitoring patients, who require higher daily doses, more closely, Tramadol has been found moderately effective in peripheral neuropathic pain, yet it should be used with caution in elderly patients for risk of confusion. Other medications developed for other indications like anti-depressants and anti-convulsants. Tricyclic antidepressants (TCA's), selective serotonin nor epinephrine reuptake inhibitors (SNRI's), monoamine oxidase inhibitors (MAO inhibitors) are antidepressant agents that reduce chronic neuropathic pain in addition to their role in treatment of depression and pain related sleep interference, However, their induced sedation and dizziness interfered with patients' quality of life and their doses as well should be monitored for patients with renal insufficiency However, TCA's may cause cardiac conduction block, orthostatic hypotension, sedation, and confusion. SNRI's and MAO inhibitors cause nausea, loss of appetite, constipation, sedation, and anxiety Lidocaine is an amide local anesthetic with a wide range of mechanisms of action. Lidocaine found to successfully provide pain relief in several chronic neuropathic conditions that have failed other treatment modalities when given in low dose intravenous infusion. Lidocaine infusion is inexpensive, relatively easily administrated and has been safely used with few side effects. It also has opioid sparing effect.\n\nIt has been reported that even single infusion may lead to prolonged analgesia that could allow the reduction of use of co-analgesics and related toxicities, Hence, in the current study, the investigators aim to compare of lidocaine iv injection with two different doses for patients with neuropathic pain developed after mastectomy."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18years.\n* Females with neuropathic pain following mastectomy for cancer breast.\n* American Society of Anesthesiologists (ASA) physical status I-III.\n* Patients on other drugs with intolerable side effects.\n* Patients undergoing breast surgery\n\nExclusion Criteria:\n\n* Patients with known hypersensitivity to lidocaine.\n* Patients with history of uncontrolled seizures.\n* Patients with second- or third-degree heart block.\n* Patients with altered cognitive dysfunction.'}, 'identificationModule': {'nctId': 'NCT07475520', 'briefTitle': 'Lidocaine IV Injection With Different Doses for Patients With Neuropathic Pain After Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparative Study of Lidocaine IV Injection With Two Different Doses for Patients With Neuropathic Pain Who Undergoing Mastectomy for Cancer Breast', 'orgStudyIdInfo': {'id': '2107-301-031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine 2 mg/kg', 'description': 'Patients receive 2 mg/kg lidocaine IV injection over 30 minutes.', 'interventionNames': ['Drug: Lidocaine 2%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine 6 mg/kg', 'description': 'Patients receive 6 mg/kg lidocaine IV injection over 30 minutes', 'interventionNames': ['Drug: Lidocaine']}], 'interventions': [{'name': 'Lidocaine 2%', 'type': 'DRUG', 'description': 'Lidocaine 2 mg/kg IV injection over 30 minutes', 'armGroupLabels': ['Lidocaine 2 mg/kg']}, {'name': 'Lidocaine', 'type': 'DRUG', 'description': 'Lidocaine 6 mg/kg IV injection over 30 minutes', 'armGroupLabels': ['Lidocaine 6 mg/kg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'National Cancer Institute, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mai Helaly, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National cancer institute, cairo university'}, {'name': 'Ehab Hanafy Gendy, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'National cancer institute, cairo university'}, {'name': 'Maie El Rawas', 'role': 'STUDY_CHAIR', 'affiliation': 'National cancer institute, cairo university'}, {'name': 'Fady Samy Saad', 'role': 'STUDY_CHAIR', 'affiliation': 'National cancer institute, cairo university'}, {'name': 'Vivian Shoukry Hannah', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National cancer institute, cairo university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Ahmed Shaaban Glall Ismail', 'investigatorAffiliation': 'Cairo University'}}}}