Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
NCT07922759, Phase 4, Recruiting, University Medical Centre Ljubljana
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery | ClinicalTrials.gov |
| NCT number | NCT07922759 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 20 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Medical Centre Ljubljana | ClinicalTrials.gov |
| Conditions | Head and Neck Cancer (H&N) | ClinicalTrials.gov |
| Interventions | Lidocaine HCl 1% | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Serum Interleukin-6 (IL-6) Concentration | 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. | ClinicalTrials.gov |
| Primary | Change in Serum Interleukin-8 (IL-8) Concentration | 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. | ClinicalTrials.gov |
| Primary | Change in Serum Interleukin-10 (IL-10) Concentration | 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. | ClinicalTrials.gov |
| Primary | Change in Serum Neuron-Specific Enolase (NSE) Concentration | 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. | ClinicalTrials.gov |
| Primary | Change in Serum S100 Beta (S100β) Protein Concentration | 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. | ClinicalTrials.gov |
| Primary | Change in Serum Glial Fibrillary Acidic Protein (GFAP) Concentration | 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. | ClinicalTrials.gov |
| Primary | Change in Serum Matrix Metalloproteinase-9 (MMP-9) Concentration | 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. | ClinicalTrials.gov |
| Secondary | Change in Cognitive Function Assessed by the Mini-Mental State Examination (MMSE) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)