- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07359469
Intravenous Lidocaine, Ketamine, and Magnesium in Thoracic Surgery (LKM-Thorax)
Evaluation of Intraoperative Intravenous Lidocaine, Ketamine, and Magnesium on Postoperative Pain and Opioid Use After Pulmonary Resection: A Prospective Observational Cohort Study
Study Overview
Status
Detailed Description
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.
The 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.
This 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Girona, Spain, 17007
- University Hospital Dr. Josep Trueta
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18 years or older.
- Scheduled for elective pulmonary resection (thoracotomy or VATS).
- Able to provide informed consent.
- ASA physical status I-IV.
Exclusion Criteria:
- Emergency surgery.
- Known allergy or contraindication to lidocaine, ketamine, or magnesium.
- Severe hepatic insufficiency.
- Severe renal dysfunction (eGFR < 30 mL/min/1.73 m²).
- Pre-existing significant arrhythmias (e.g., uncontrolled atrial fibrillation, ventricular arrhythmias).
- Pregnancy.
- Cognitive impairment preventing valid informed consent.
- Patients receiving chronic intravenous analgesics or regional anesthesia techniques preoperatively.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Lidocaine-Ketamine-Magnesium Group (LKM)
Adult patients undergoing elective pulmonary resection who received intraoperative multimodal analgesia including continuous infusions of lidocaine, ketamine, and magnesium according to institutional protocol.
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Standard Analgesia Control Group
Adult patients undergoing elective pulmonary resection who received standard intraoperative analgesia without lidocaine, ketamine, or magnesium infusion.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Total intravenous morphine consumption within the first 24 hours postoperatively.
Time Frame: First 24 postoperative hours
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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.
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First 24 postoperative hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain intensity at 3 and 24 hours postoperatively, assessed using a 10-point Visual Analogue Scale (VAS), chronic pain ( 3 months)
Time Frame: 3 hours, 24 hours, and 3 months after surgery
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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.
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3 hours, 24 hours, and 3 months after surgery
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Safety Outcomes
Time Frame: Perioperative period (day of surgery through postoperative day 7) and at 3 months
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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).
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Perioperative period (day of surgery through postoperative day 7) and at 3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Manuel Murie Fernandez, MD, PhD, Universidad Pública de Navarra ( UPNA)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FR-CP01
- EDONA-UPNA-2025 (Other Identifier: Universidad Pública de Navarra (UPNA))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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