Head and Neck Cancer (H&N)Phase 4NCT07922759
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
A Phase 4 study testing Lidocaine HCl 1% in people with Head and Neck Cancer (H&N), run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer (H&N)
- What is being tested?
- Lidocaine HCl 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSlovenia
- Study dates
- 20 Jun 2026to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Pregnancy or breastfeeding.
- Pre-existing neurological diseases.
- Psychiatric disorders.
- Preoperative Mini-Mental State Examination (MMSE) score < 23 points.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana, 1000
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Head and Neck Cancer (H&N)
- Being tested
- Lidocaine HCl 1%
- Keywords
- Lidocaine, Local Anesthetic Infiltration, Head and Neck Cancer Surgery, Neuroimmunomodulation, Perioperative Inflammation, Neurological Biomarkers, Postoperative Cognitive Function, Microvascular Free-Flap Reconstruction
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine HCl 1%Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Higher-Dose Lidocaine (300 mg) | Experimental | 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. Receives: Drug: Lidocaine HCl 1% |
| Lower-Dose Lidocaine (150 mg) | Experimental | 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. Receives: Drug: Lidocaine HCl 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Interleukin-6 (IL-6) Concentration
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Immediately before surgery (baseline), 6 hours after surgical incision, and at 08:00 on postoperative days 1, 2, and 6.
Secondary outcomes (1)
Change in Cognitive Function Assessed by the Mini-Mental State Examination (MMSE)
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.
Measured: Preoperatively (baseline), on postoperative day 6, and at 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 posted6 Nov 2026
- Study start20 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Cancer (H&N)Studies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This prospective, randomized, two-arm pilot study uses a parallel assignment design. Twenty adult patients undergoing head and neck cancer resection with microvascular free-flap reconstruction will be randomly assigned to one of two groups (10 participants per group). Participants will receive surgical-field infiltration with either 300 mg or 150 mg of lidocaine. Both groups will receive the same total infiltration volume (50 mL) and adrenaline dose (0.5 mg). Perioperative inflammatory and neurological biomarkers and postoperative cognitive function will be compared between the two groups.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liljana Markova, MD, PhD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922759
- Sponsor's protocol ID
- 20250227
- Status last verified
- Oct 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine and Neuroimmunomodulation: The Effect of Local Anesthetic Concentration in Head and Neck Cancer Resections
- ClinicalTrials.gov ID
- NCT07922759
- Acronym / sponsor ID
- 20250227
- Conditions
- Head and Neck Cancer (H&N)
- Keywords
- Lidocaine, Local Anesthetic Infiltration, Head and Neck Cancer Surgery, Neuroimmunomodulation, Perioperative Inflammation, Neurological Biomarkers, Postoperative Cognitive Function, Microvascular Free-Flap Reconstruction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 20 Jun 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Nov 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- This prospective, randomized, two-arm pilot study uses a parallel assignment design. Twenty adult patients undergoing head and neck cancer resection with microvascular free-flap reconstruction will be randomly assigned to one of two groups (10 participants per group). Participants will receive surgical-field infiltration with either 300 mg or 150 mg of lidocaine. Both groups will receive the same total infiltration volume (50 mL) and adrenaline dose (0.5 mg). Perioperative inflammatory and neurological biomarkers and postoperative cognitive function will be compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Higher-Dose Lidocaine (300 mg) | Experimental | Drug: Lidocaine HCl 1%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. |
| Lower-Dose Lidocaine (150 mg) | Experimental | Drug: Lidocaine HCl 1%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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Higher-Dose Lidocaine (300 mg), Lower-Dose Lidocaine (150 mg) |
Primary outcome
Change in Serum Interleukin-6 (IL-6) Concentration
Time frame: 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.
Change in Serum Interleukin-8 (IL-8) Concentration
Time frame: 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.
Change in Serum Interleukin-10 (IL-10) Concentration
Time frame: 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.
Change in Serum Neuron-Specific Enolase (NSE) Concentration
Time frame: 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.
Change in Serum S100 Beta (S100β) Protein Concentration
Time frame: 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.
Change in Serum Glial Fibrillary Acidic Protein (GFAP) Concentration
Time frame: 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.
Change in Serum Matrix Metalloproteinase-9 (MMP-9) Concentration
Time frame: 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.
1 secondary outcome
Change in Cognitive Function Assessed by the Mini-Mental State Examination (MMSE)
Time frame: Preoperatively (baseline), on postoperative day 6, and at 3 months after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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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.
Liljana Markova, MD, PhD principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine HCl 1% in people with Head and Neck Cancer (H&N), run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 6 Nov 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 Slovenia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liljana Markova, MD, PhD (+38640802662, liljana.markova@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Interleukin-6 (IL-6) Concentration (time frame: Immediately before surgery (baseline), 6 hours after surgical incision, and at 08:00 on postoperative days 1, 2, and 6.). The study lists 7 primary outcomes in all. 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 6 Nov 2026.