Lidocaine Infiltration to See If It Helps Inflammation and Brain Function After Head and Neck Cancer Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized pilot trial in adults undergoing oncological head and neck resection with microvascular free-flap reconstruction. Participants are assigned to receive either 150 mg or 300 mg of lidocaine infiltrated in the surgical field at the start of surgery, to explore effects on perioperative inflammation, neuronal/glial injury biomarkers, and postoperative cognitive function. The study uses a prospective design to compare dose-related biological and neurocognitive responses in a single-center setting at University Medical Centre Ljubljana. Outcomes will inform whether local lidocaine infiltration at different doses modulates systemic stress and neuroinflammatory processes after major head and neck cancer procedures. No results are provided yet as this is an initial pilot to assess feasibility and signal of effect.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients aged 18 years or older.
* Patients scheduled for oncological resection of head and neck cancer followed by microvascular soft-tissue free-flap reconstruction.
* Body mass index (BMI) \< 30 kg/m².
* No known hypersensitivity to amide-type local anesthetics or components of the infiltration solutions.
* Ability and willingness to provide written informed consent for participation in the study.

Exclusion Criteria:

* Refusal to participate or inability to provide written informed consent.
* Known hypersensitivity to lidocaine or any component of the infiltration solution.
* Heart failure with a left ventricular ejection fraction \< 50%.
* Cardiac conduction disorders without an implanted pacemaker.
* Uncontrolled epilepsy.
* Hepatic or renal insufficiency.
* Pregnancy or breastfeeding.
* Pre-existing neurological diseases.
* Psychiatric disorders.
* Preoperative Mini-Mental State Examination (MMSE) score \< 23 points.

Where it's running

• University Medical Centre Ljubljana
  Ljubljana, Slovenia Recruiting

Study contacts

• Principal investigator: Liljana Markova, MD, PhD — University Medical Centre Ljubljana
• Study coordinator: Liljana Markova, MD, PhD
• Email: liljana.markova@kclj.si
• Phone: +38640802662

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.