Postoperative PainLKM-ThoraxNCT07359469
Intravenous Lidocaine, Ketamine, and Magnesium in Thoracic Surgery
An observational study of Postoperative Pain and Thoracic Surgery, run by Universidad Pública de Navarra at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Thoracic Surgery, Multimodal Analgesia
- Type of treatment
- Injection or infusion
- How many people
- 118 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2018to 3 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adults aged 18 years or older.
- Scheduled for elective pulmonary resection (thoracotomy or VATS).
- Able to provide informed consent.
- ASA physical status I-IV.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Intraoperative Intravenous Lidocaine, Ketamine, and Magnesium on Postoperative Pain and Opioid Use After Pulmonary Resection: A Prospective Observational Cohort Study
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.
Read the 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.
- Conditions
- Postoperative Pain, Thoracic Surgery, Multimodal Analgesia, Opioid Consumption, Postoperative
- Keywords
- Multimodal analgesia, Lidocaine, Ketamine, Magnesium sulphate, Opioid consumption, VAS pain score, thoracotomy, VATS surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| Standard Analgesia Control Group | Adult patients undergoing elective pulmonary resection who received standard intraoperative analgesia without lidocaine, ketamine, or magnesium infusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intravenous morphine consumption within the first 24 hours postoperatively.
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.
Measured: First 24 postoperative hours
Secondary outcomes (1)
Pain intensity at 3 and 24 hours postoperatively, assessed using a 10-point Visual Analogue Scale (VAS), chronic pain ( 3 months)
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.
Measured: 3 hours, 24 hours, and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Jan 2018
- Primary completion3 Feb 2022
- Study completion3 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Pública de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel Murie Fernandez, MD, PhD, Principal investigator, Universidad Pública de Navarra ( UPNA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359469
- Sponsor's protocol ID
- FR-CP01
- Other IDs
- EDONA-UPNA-2025
- Acronym
- LKM-Thorax
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intraoperative Intravenous Lidocaine, Ketamine, and Magnesium on Postoperative Pain and Opioid Use After Pulmonary Resection: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07359469
- Acronym / sponsor ID
- LKM-Thorax / FR-CP01
- Conditions
- Postoperative Pain, Thoracic Surgery, Multimodal Analgesia, Opioid Consumption, Postoperative
- Keywords
- Multimodal analgesia, Lidocaine, Ketamine, Magnesium sulphate, Opioid consumption, VAS pain score, thoracotomy, VATS surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Universidad Pública de NavarraUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Standard Analgesia Control Group | – | –Adult patients undergoing elective pulmonary resection who received standard intraoperative analgesia without lidocaine, ketamine, or magnesium infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Scheduled for elective pulmonary resection (thoracotomy or VATS).
- Able to provide informed consent.
- ASA physical status I-IV.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Murie Fernandez, MD, PhD principal investigator
Universidad Pública de Navarra ( UPNA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Thoracic Surgery, run by Universidad Pública de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total intravenous morphine consumption within the first 24 hours postoperatively. (time frame: First 24 postoperative hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.