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Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery

2 listopada 2026 zaktualizowane przez: University Medical Centre Ljubljana

Lidocaine and Neuroimmunomodulation: The Effect of Local Anesthetic Concentration in Head and Neck Cancer Resections

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

Major head and neck cancer surgery, particularly oncological resection followed by microvascular free-flap reconstruction, is associated with substantial physiological stress, systemic inflammation, and an increased risk of postoperative neurological and cognitive disturbances. These effects may be especially pronounced in patients with pre-existing comorbidities and reduced physiological reserves.

Lidocaine is a widely used local anesthetic with established analgesic properties and potential anti-inflammatory, immunomodulatory, and neuroprotective effects. Experimental and clinical studies have demonstrated its effects on inflammatory cytokine release, neutrophil activation, and endothelial permeability. However, most available perioperative evidence concerns intravenous lidocaine administration, while the potential systemic and neurological effects of local surgical-field infiltration remain insufficiently investigated.

This prospective, randomized, two-arm pilot study aims to explore whether different doses of locally infiltrated lidocaine influence perioperative inflammatory responses, biomarkers associated with neuronal and glial injury, and postoperative cognitive function in patients undergoing major head and neck cancer surgery.

The study will be conducted at University Medical Centre Ljubljana, Slovenia, and will include 20 adult patients undergoing oncological head and neck resection with microvascular soft-tissue free-flap reconstruction. Participants will be randomized into two groups receiving either 300 mg or 150 mg of lidocaine infiltrated into the surgical field. Both infiltration solutions will have an identical total volume of 50 mL and contain the same amount of adrenaline (0.5 mg), allowing comparison between the two lidocaine doses.

General anesthesia will be standardized using total intravenous anesthesia (TIVA) with propofol and remifentanil, administered by manual infusion or target-controlled infusion (TCI). Intraoperative monitoring will include invasive arterial blood pressure, oxygen saturation, heart rate, body temperature, urine output, and processed electroencephalographic monitoring of anesthetic depth.

The inflammatory response will be assessed by measuring serum concentrations of interleukin-6 (IL-6), interleukin-8 (IL-8), and interleukin-10 (IL-10). Biomarkers associated with neuronal, glial, and neurovascular injury will include neuron-specific enolase (NSE), S100β protein, glial fibrillary acidic protein (GFAP), and matrix metalloproteinase-9 (MMP-9).

Five blood samples of 7 mL each (two 3.5 mL serum collection tubes per sampling time point) will be collected immediately before surgery, six hours after surgical incision, and at 08:00 on postoperative days 1, 2, and 6. The total blood volume collected for research purposes will be 35 mL per participant.

Cognitive function will be evaluated using the Mini-Mental State Examination (MMSE) before surgery, on postoperative day 6, and three months after surgery.

The study will explore differences in perioperative biomarker trajectories between the two lidocaine-dose groups and investigate potential associations between systemic inflammatory responses, neurological biomarkers, and postoperative cognitive function.

Given the limited sample size, the study is designed as an exploratory pilot investigation rather than a definitive efficacy trial. The primary scientific purpose is to characterize perioperative biological responses, estimate the magnitude and variability of potential dose-related effects, and generate preliminary evidence to inform the selection of outcome measures and sample size for a larger randomized clinical study.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

20

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Słowenia
      • Ljubljana, Słowenia, 1000
        • Rekrutacyjny
        • University Medical Centre Ljubljana

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Higher-Dose Lidocaine (300 mg)

Participants assigned to this group will receive surgical-field infiltration with 30 mL of 1% lidocaine (300 mg), 0.5 mg of adrenaline, and 20 mL of 0.9% sodium chloride solution. The total infiltration volume will be 50 mL. The infiltration will be administered at the beginning of surgery for head and neck cancer resection with microvascular free-flap reconstruction.
Lek: Lidocaine HCl 1%

Lidocaine hydrochloride 1% solution will be administered by local infiltration into the surgical field at the beginning of head and neck cancer surgery.

Participants will be randomized to receive one of two doses:

Higher-dose group: 30 mL of 1% lidocaine (300 mg), combined with 0.5 mg of adrenaline and 20 mL of 0.9% sodium chloride solution.

Lower-dose group: 15 mL of 1% lidocaine (150 mg), combined with 0.5 mg of adrenaline and 35 mL of 0.9% sodium chloride solution.

Both groups will receive a total infiltration volume of 50 mL and an identical adrenaline dose (0.5 mg). The intervention will be administered once, at the beginning of surgery.
Eksperymentalny: Lower-Dose Lidocaine (150 mg)

Participants assigned to this group will receive surgical-field infiltration with 15 mL of 1% lidocaine (150 mg), 0.5 mg of adrenaline, and 35 mL of 0.9% sodium chloride solution. The total infiltration volume will be 50 mL. The infiltration will be administered at the beginning of surgery for head and neck cancer resection with microvascular free-flap reconstruction.
Lek: Lidocaine HCl 1%

Lidocaine hydrochloride 1% solution will be administered by local infiltration into the surgical field at the beginning of head and neck cancer surgery.

Participants will be randomized to receive one of two doses:

Higher-dose group: 30 mL of 1% lidocaine (300 mg), combined with 0.5 mg of adrenaline and 20 mL of 0.9% sodium chloride solution.

Lower-dose group: 15 mL of 1% lidocaine (150 mg), combined with 0.5 mg of adrenaline and 35 mL of 0.9% sodium chloride solution.

Both groups will receive a total infiltration volume of 50 mL and an identical adrenaline dose (0.5 mg). The intervention will be administered once, at the beginning of surgery.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Serum Interleukin-6 (IL-6) Concentration
Ramy czasowe: Immediately before surgery (baseline), 6 hours after surgical incision, and at 08:00 on postoperative days 1, 2, and 6.

Changes in serum interleukin-6 (IL-6) concentration relative to the preoperative baseline will be assessed at four postoperative time points. IL-6 concentrations and absolute changes from baseline will be expressed in picograms per milliliter (pg/mL). The magnitude and temporal pattern of changes will be compared between patients receiving 150 mg and 300 mg of infiltrated lidocaine.
Immediately before surgery (baseline), 6 hours after surgical incision, and at 08:00 on postoperative days 1, 2, and 6.
Change in Serum Interleukin-8 (IL-8) Concentration
Ramy czasowe: Immediately before surgery (baseline), 6 hours after surgical incision, and at 08:00 on postoperative days 1, 2, and 6.

Changes in serum interleukin-8 (IL-8) concentration relative to the preoperative baseline will be assessed at four postoperative time points. IL-8 concentrations and absolute changes from baseline will be expressed in picograms per milliliter (pg/mL). The magnitude and temporal pattern of changes will be compared between patients receiving 150 mg and 300 mg of infiltrated lidocaine.
Immediately before surgery (baseline), 6 hours after surgical incision, and at 08:00 on postoperative days 1, 2, and 6.
Change in Serum Interleukin-10 (IL-10) Concentration
Ramy czasowe: Immediately before surgery (baseline), 6 hours after surgical incision, and at 08:00 on postoperative days 1, 2, and 6.

Changes in serum interleukin-10 (IL-10) concentration relative to the preoperative baseline will be assessed at four postoperative time points. IL-10 is an anti-inflammatory cytokine involved in the regulation of immune responses. IL-10 concentrations and absolute changes from baseline will be expressed in picograms per milliliter (pg/mL). The magnitude and temporal pattern of changes will be compared between patients receiving 150 mg and 300 mg of infiltrated lidocaine.
Immediately before surgery (baseline), 6 hours after surgical incision, and at 08:00 on postoperative days 1, 2, and 6.
Change in Serum Neuron-Specific Enolase (NSE) Concentration
Ramy czasowe: Immediately before surgery (baseline), 6 hours after surgical incision, and at 08:00 on postoperative days 1, 2, and 6.

Changes in serum neuron-specific enolase (NSE) concentration relative to the preoperative baseline will be assessed at four postoperative time points. NSE is a biomarker associated with neuronal injury and neurological stress. NSE concentrations and absolute changes from baseline will be expressed in nanograms per milliliter (ng/mL). The magnitude and temporal pattern of changes will be compared between patients receiving 150 mg and 300 mg of infiltrated lidocaine.
Immediately before surgery (baseline), 6 hours after surgical incision, and at 08:00 on postoperative days 1, 2, and 6.
Change in Serum S100 Beta (S100β) Protein Concentration
Ramy czasowe: Immediately before surgery (baseline), 6 hours after surgical incision, and at 08:00 on postoperative days 1, 2, and 6.

Changes in serum S100 beta (S100β) protein concentration relative to the preoperative baseline will be assessed at four postoperative time points. S100β is a biomarker associated with glial cell injury and neurological stress. S100β concentrations and absolute changes from baseline will be expressed in micrograms per liter (µg/L). The magnitude and temporal pattern of changes will be compared between patients receiving 150 mg and 300 mg of infiltrated lidocaine.
Immediately before surgery (baseline), 6 hours after surgical incision, and at 08:00 on postoperative days 1, 2, and 6.
Change in Serum Glial Fibrillary Acidic Protein (GFAP) Concentration
Ramy czasowe: Immediately before surgery (baseline), 6 hours after surgical incision, and at 08:00 on postoperative days 1, 2, and 6.

Changes in serum glial fibrillary acidic protein (GFAP) concentration relative to the preoperative baseline will be assessed at four postoperative time points. GFAP is a biomarker associated with astrocytic injury and neurological stress. GFAP concentrations and absolute changes from baseline will be expressed in picograms per milliliter (pg/mL). The magnitude and temporal pattern of changes will be compared between patients receiving 150 mg and 300 mg of infiltrated lidocaine.
Immediately before surgery (baseline), 6 hours after surgical incision, and at 08:00 on postoperative days 1, 2, and 6.
Change in Serum Matrix Metalloproteinase-9 (MMP-9) Concentration
Ramy czasowe: Immediately before surgery (baseline), 6 hours after surgical incision, and at 08:00 on postoperative days 1, 2, and 6.

Changes in serum matrix metalloproteinase-9 (MMP-9) concentration relative to the preoperative baseline will be assessed at four postoperative time points. MMP-9 is involved in extracellular matrix remodeling, inflammatory processes, and neurovascular responses. MMP-9 concentrations and absolute changes from baseline will be expressed in nanograms per milliliter (ng/mL). The magnitude and temporal pattern of changes will be compared between patients receiving 150 mg and 300 mg of infiltrated lidocaine.
Immediately before surgery (baseline), 6 hours after surgical incision, and at 08:00 on postoperative days 1, 2, and 6.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Cognitive Function Assessed by the Mini-Mental State Examination (MMSE)
Ramy czasowe: Preoperatively (baseline), on postoperative day 6, and at 3 months after surgery.

Changes in cognitive function relative to the preoperative baseline will be assessed using the Mini-Mental State Examination (MMSE), with scores ranging from 0 to 30 points; higher scores indicate better cognitive performance. Assessments will be performed preoperatively, on postoperative day 6, and at 3 months. For patients unable to speak after surgery due to surgical or airway-related limitations, written responses may be accepted instead of verbal responses where feasible. Adaptations will be documented. Changes in MMSE scores will be compared between the 150 mg and 300 mg lidocaine groups.
Preoperatively (baseline), on postoperative day 6, and at 3 months after surgery.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University Medical Centre Ljubljana

Śledczy

  • Główny śledczy: Liljana Markova, MD, PhD, University Medical Centre Ljubljana

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

20 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 czerwca 2028

Ukończenie studiów (Szacowany)

1 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

2 listopada 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 listopada 2026

Pierwszy wysłany (Rzeczywisty)

6 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 20250227

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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