NCT07922759RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Lidocaine and Neuroimmunomodulation: The Effect of Local Anesthetic Concentration in Head and Neck Cancer Resections
Source: ClinicalTrials.gov · Last updated 6 Nov 2026
Brief summary (registry, in English)
This study aims to investigate whether different doses of locally infiltrated lidocaine affect inflammation, neurological biomarkers, and cognitive function in patients undergoing major head and neck cancer surgery. Major head and neck cancer surgery can cause substantial physical stress, inflammation, and changes in cognitive function after surgery. Lidocaine is a commonly used local anesthetic that may also have anti-inflammatory and protective effects on the nervous system. However, little is known about whether the dose of lidocaine injected into the surgical area influences these responses. This prospective, randomized pilot study will include 20 adult patients undergoing head and neck cancer resection followed by microvascular free-flap reconstruction at University Medical Centre Ljubljana, Slovenia. Participants will be randomly assigned to receive either 150 mg or 300 mg of lidocaine infiltrated into the surgical area at the beginning of surgery. Both groups will receive the same total volume of infiltration solution and the same dose of adrenaline. Blood samples will be collected before surgery, six hours after surgical incision, and on postoperative days 1, 2, and 6 to measure inflammatory and neurological biomarkers. Cognitive function will be assessed before surgery, on postoperative day 6, and three months after surgery. The study will explore whether the higher dose of lidocaine is associated with differences in inflammatory responses, neurological biomarkers, and postoperative cognitive function. The findings will help inform the design of larger future clinical studies.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 2 Nov 2026
- Start date
- 20 Jun 2026
- Primary completion date
- Jun 2028
- Lead sponsor
- University Medical Centre Ljubljana
- Diseases
- Head and neck cancer
- NCT number
- NCT07922759
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 20
- From 20 Jun 2026 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known hypersensitivity to lidocaine or any component of the infiltration solution.
- Cardiac conduction disorders without an implanted pacemaker.
- Uncontrolled epilepsy.
- Hepatic or renal insufficiency.
- Pre-existing neurological diseases.
- Psychiatric disorders.
Lab values
- Heart failure with a left ventricular ejection fraction < 50%.
Other
- Refusal to participate or inability to provide written informed consent.
- Pregnancy or breastfeeding.
- Preoperative Mini-Mental State Examination (MMSE) score < 23 points.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Centre Ljubljana | Ljubljana | Slovenia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.