Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:29 PM
Study NCT ID:
NCT07359469
Status:
COMPLETED
Last Update Posted:
2026-01-22
First Post:
2025-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Lidocaine, Ketamine, and Magnesium in Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-13', 'studyFirstSubmitDate': '2025-12-09', 'studyFirstSubmitQcDate': '2026-01-13', 'lastUpdatePostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety Outcomes', 'timeFrame': 'Perioperative period (day of surgery through postoperative day 7) and at 3 months', 'description': 'Incidence of perioperative and postoperative adverse events, including hypotension, bradycardia, atrial fibrillation, deep vein thrombosis (DVT), pulmonary embolism (PE), prolonged hospital stay, in-hospital mortality, and survival status at 3 months. All events will be recorded as present or absent (yes/no).'}], 'primaryOutcomes': [{'measure': 'Total intravenous morphine consumption within the first 24 hours postoperatively.', 'timeFrame': 'First 24 postoperative hours', 'description': 'Total amount of intravenous morphine administered during the first 24 postoperative hours. Values will be recorded in milligrams (mg). Higher values indicate greater opioid consumption.'}], 'secondaryOutcomes': [{'measure': 'Pain intensity at 3 and 24 hours postoperatively, assessed using a 10-point Visual Analogue Scale (VAS), chronic pain ( 3 months)', 'timeFrame': '3 hours, 24 hours, and 3 months after surgery', 'description': 'Pain intensity assessed using a 10-point Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents the worst imaginable pain. Measurements will be recorded at 3 hours, 24 hours, and 3 months after surgery. Higher scores indicate greater pain intensity. Pain persisting at 3 months will be classified as chronic post-surgical pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multimodal analgesia', 'Lidocaine', 'Ketamine', 'Magnesium sulphate', 'Opioid consumption', 'VAS pain score', 'thoracotomy', 'VATS surgery'], 'conditions': ['Postoperative Pain', 'Thoracic Surgery', 'Multimodal Analgesia', 'Opioid Consumption, Postoperative']}, 'descriptionModule': {'briefSummary': 'Thoracic surgery often produces severe postoperative pain due to nerve injury and inflammation. Effective pain control is essential to reduce complications and opioid use. This prospective observational cohort study evaluated adult patients undergoing pulmonary resection by thoracotomy or video-assisted thoracoscopic surgery (VATS). The study examined whether intraoperative administration of intravenous lidocaine, ketamine, and magnesium, used as part of multimodal analgesia, was associated with reduced postoperative morphine consumption and lower early postoperative pain scores. Outcomes included 24-hour morphine use, pain intensity at 3 and 24 hours, complications, and chronic pain at 3 months. No study-directed interventions were performed; anesthetic management followed routine clinical practice.', 'detailedDescription': 'This prospective observational cohort study included 118 adult patients undergoing elective pulmonary resection between 2018 and 2022. The objective was to evaluate the association between intraoperative intravenous lidocaine, ketamine, and magnesium (LKM) and postoperative analgesic outcomes. Seventy-one patients received intraoperative LKM as part of a standardized multimodal analgesic protocol, consisting of lidocaine (1.5 mg/kg bolus followed by 1.5 mg/kg/h infusion), ketamine (0.3 mg/kg bolus), and magnesium sulfate (1.5 g bolus). Forty-seven patients received standard anesthesia without LKM administration. No study-specific interventions were assigned; exposure was based on routine anesthetic practice.\n\nThe primary outcome was total intravenous morphine consumption during the first 24 postoperative hours. Secondary outcomes included pain scores (VAS) at 3 and 24 hours, incidence of chronic postoperative pain at 3 months, pulmonary and cardiovascular complications, renal injury, thromboembolic events, hospital length of stay, and mortality. Safety monitoring included hypotension, bradycardia, arrhythmias, hallucinations, and delayed emergence from anesthesia.\n\nThis study aimed to identify perioperative factors influencing postoperative pain and opioid use after thoracic surgery, while evaluating the potential benefit of LKM within a multimodal analgesia strategy. All patients provided informed consent, and the study was approved by the local ethics committee. Data collection and clinical management followed standard institutional protocols.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing elective pulmonary resection (thoracotomy or video-assisted thoracoscopic surgery) at University Hospital Dr. Josep Trueta. The study population includes individuals receiving standard perioperative analgesic management and monitored in the postoperative care unit. Patients represent a typical thoracic surgery clinical population treated in routine practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Scheduled for elective pulmonary resection (thoracotomy or VATS).\n* Able to provide informed consent.\n* ASA physical status I-IV.\n\nExclusion Criteria:\n\n* Emergency surgery.\n* Known allergy or contraindication to lidocaine, ketamine, or magnesium.\n* Severe hepatic insufficiency.\n* Severe renal dysfunction (eGFR \\< 30 mL/min/1.73 m²).\n* Pre-existing significant arrhythmias (e.g., uncontrolled atrial fibrillation, ventricular arrhythmias).\n* Pregnancy.\n* Cognitive impairment preventing valid informed consent.\n* Patients receiving chronic intravenous analgesics or regional anesthesia techniques preoperatively.'}, 'identificationModule': {'nctId': 'NCT07359469', 'acronym': 'LKM-Thorax', 'briefTitle': 'Intravenous Lidocaine, Ketamine, and Magnesium in Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Pública de Navarra'}, 'officialTitle': 'Evaluation of Intraoperative Intravenous Lidocaine, Ketamine, and Magnesium on Postoperative Pain and Opioid Use After Pulmonary Resection: A Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': 'FR-CP01'}, 'secondaryIdInfos': [{'id': 'EDONA-UPNA-2025', 'type': 'OTHER', 'domain': 'Universidad Pública de Navarra (UPNA)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lidocaine-Ketamine-Magnesium Group (LKM)', 'description': 'Adult patients undergoing elective pulmonary resection who received intraoperative multimodal analgesia including continuous infusions of lidocaine, ketamine, and magnesium according to institutional protocol.'}, {'label': 'Standard Analgesia Control Group', 'description': 'Adult patients undergoing elective pulmonary resection who received standard intraoperative analgesia without lidocaine, ketamine, or magnesium infusion.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '17007', 'city': 'Girona', 'country': 'Spain', 'facility': 'University Hospital Dr. Josep Trueta', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}], 'overallOfficials': [{'name': 'Manuel Murie Fernandez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Pública de Navarra ( UPNA)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared because the study is observational and involves retrospective data collected as part of routine clinical care. Data cannot be shared publicly due to privacy and confidentiality restrictions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Pública de Navarra', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}