Randomized and controlled clinical trial of the efficacy and safety of the use of lidocaine and magnesium sulfate for lung resection surgery using Video-Assisted Thoracic Surgery (VATS)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Clinica Universidad De Navarra

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

25 Nov 2025 → ongoing

Decision date (initial)

2024-05-07

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

University Clinic of Navarra

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To analyze whether the intravenous administration of lidocaine and magnesium sulfate during the intraoperative period of patients with lung resection using VATS reduces morphine consumption in the first 24 postoperative hours.

Secondary objectives 21

1. To analyze whether the intravenous administration of lidocaine and magnesium sulfate during the intraoperative period of patients with lung resection reduces postoperative morphine consumption in the first 8 and 12 hours.
2. To determine if the combined use of lidocaine and intravenous magnesium sulfate during the intraoperative period is associated with less intensity of pain, at rest and during deep breathing, assessed at 3 hours, 6 hours and 24 hours, using the VAS scale (0 = no pain). and 100=the worst pain imaginable) and the 4-point ordinal scale “Verbal rating Scale” VRS (0=no pain, 1=mild pain, 2=moderate pain, 3=intense or severe pain).
3. Determinar si el uso combinado de lidocaína y sulfato magnesio endovenoso durante el periodo intraoperatorio se asocia con menor incidencia de dolor crónico posoperatorio a los 3 y 7 meses, medido mediante el “Verbal Rating Scale”.
4. To determine whether the combined use of lidocaine and intravenous magnesium sulfate reduces the incidence of localized neuropathic pain at 20 days, at 3 months and at 7 months measured using the “PainDetect” scale.
5. To determine whether the combined use of lidocaine and intravenous magnesium sulfate reduces ICU stay and hospital stay.
6. Determine the prevalence of adverse events (significant bradycardia, hypotension, pruritus, nausea, vomiting, arrhythmias, postoperative somnolence, metallic taste, dizziness, vertigo, agitation, oral hypoesthesia) in both groups.
7. To determine whether the combined use of lidocaine and intravenous magnesium sulfate reduces serious and non-serious pulmonary complications during the first 7 days, 20 days, 3 and 7 months.
8. To determine if the combined use of lidocaine and intravenous magnesium sulfate reduces non-pulmonary complications during the first 7 days, 20 days, 3 and 7 months.
9. To determine if the combined use of lidocaine and intravenous magnesium sulfate reduces the incidence of myocardial damage in non-cardiac surgery in the postoperative period.
10. To determine if the combined use of lidocaine and intravenous magnesium sulfate reduces the incidence of Major Cardiovascular Events (MACCE) in the postoperative period.
11. To determine if the combined use of lidocaine and intravenous magnesium sulfate reduces the incidence of new-onset Atrial Fibrillation in the postoperative period.
12. To determine if the combined use of lidocaine and intravenous magnesium sulfate reduces the incidence of postoperative surgical complications during the first 30 postoperative days.
13. To determine whether the combined use of lidocaine and intravenous magnesium sulfate improves the quality of life of patients at 20 days, 3 and 7 months, measured by the HRQoL SF-8 questionnaire.
14. To determine whether the combined use of lidocaine and intravenous magnesium sulfate reduces the incidence of postoperative cognitive dysfunction on day 3 of surgery.
15. To determine if the combined use of lidocaine and intravenous magnesium sulfate reduces the incidence of Acute Kidney Injury in patients 48 hours postoperatively or in the first 7 postoperative days.
16. To determine whether the combined use of lidocaine and intravenous magnesium sulfate improves the quality of recovery of patients at 24 and 48 hours postoperatively, measured by the QoR-15 questionnaire.
17. To determine whether the combined use of lidocaine and intravenous magnesium sulfate reduces the severity of postoperative complications using the “Clavien-Dindo” scale.
18. To determine whether the combined use of lidocaine and intravenous magnesium sulfate improves patients' lung capacity measured by respiratory function tests in the first 24 postoperative hours.
19. To determine whether the combined use of lidocaine and intravenous magnesium sulfate improves the oxygenation of patients 12 hours after admission to the ICU and 24 hours after surgery.
20. To determine whether the combined use of lidocaine and intravenous magnesium sulfate reduces the number of hospital readmissions after discharge home during the 7-month follow-up.
21. To determine whether the combined use of lidocaine and intravenous magnesium sulfate reduces the number of lung cancer recurrences 1 year after surgery.

Conditions and MedDRA coding

Lung resection surgery using Video-Assisted Thoracic Surgery (VATS)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients undergoing lung tumor resection surgery using video-assisted thoracoscopy.
2. The patient must be 18 years of age or older.
3. The patient, or his or her representative, has given consent to participate in the study.
4. The patient must, in the opinion of the investigator, be able to comply with all the requirements of the clinical trial.

Exclusion criteria 14

1. Patients who have previously been diagnosed with chronic pain prior to surgery.
2. Pregnant or breastfeeding women.
3. History of hypersensitivity to any of the components of lidocaine or magnesium sulfate.
4. Patients who for some medical reason are contraindicated in the use of lidocaine or magnesium sulfate.
5. Patients who are taking analgesics (paracetamol or non-steroidal anti-inflammatory drugs or opioids) in the 7 days prior to surgery.
6. History of alcohol or drug abuse or psychiatric illness.
7. History of Congestive Heart Failure or NYHA criteria III-IV or atrioventricular heart block.
8. Disease of the central nervous system.
9. Porphyria.
10. Patients unable to clearly understand the objectives and methodology of the study.
11. Patients with chronic kidney damage with glomerular filtration < 60 ml/min (stage III-V).
12. Patients with liver dysfunction with total bilirubin > 3mg/dL.
13. Expected surgery lasting more than 6 hours or no extubation plan immediately after surgery.
14. Patients with < 45kg and > 100kg.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Morphine consumption in the first 24 postoperative hours.

Secondary endpoints 21

1. Postoperative morphine consumption
2. Intensity of pain, at rest and with deep breathing
3. Chronic postoperative pain
4. Neuropathic pain
5. ICU stay and hospital stay.
6. Adverse events
7. Serious and non-serious pulmonary complications
8. Non-pulmonary complications
9. Myocardial damage in non-cardiac surgery
10. Major Cardiovascular Events
11. Atrial Fibrillation
12. Postoperative surgical complications
13. Quality of life
14. Postoperative cognitive dysfunction
15. Acute Kidney Injury
16. Recovery quality
17. Severity of postoperative complications
18. Lung capacity
19. Oxygenation
20. Hospital readmissions
21. Lung cancer recurrences

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Clinica Universidad De Navarra

Sponsor organisation

Clinica Universidad De Navarra

Address

Avenue Pio XII 36

City

Pamplona

Postcode

31008

Country

Spain

Scientific contact point

Organisation

Clinica Universidad De Navarra

Contact name

UCEC

Public contact point

Organisation

Clinica Universidad De Navarra

Contact name

UCEC

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications