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Completed

NCT Number: NCT07359469

Intravenous Lidocaine, Ketamine, and Magnesium in Thoracic Surgery

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.

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Key information

Conditions

Postoperative Pain Multimodal Analgesia Neurologic Manifestations Opioid Consumption, Postoperative Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Thoracic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Dr. Josep Trueta

Girona, 17007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Total intravenous morphine consumption within the first 24 hours postoperatively.

    Time frame: First 24 postoperative hours

    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.

Secondary outcomes

  1. 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

    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.

Other outcomes

  1. Safety Outcomes

    Time frame: Perioperative period (day of surgery through postoperative day 7) and at 3 months

    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).

Sponsors and collaborators

Lead sponsor

Universidad Pública de Navarra

Other

Registry information

Official study title

Evaluation of Intraoperative Intravenous Lidocaine, Ketamine, and Magnesium on Postoperative Pain and Opioid Use After Pulmonary Resection: A Prospective Observational Cohort Study

Acronym: LKM-Thorax

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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