Clinical trial · Interventional
Systemic and Local Levels of Lidocaine During Surgery for the Removal of Glioblastoma
Assessing Systemic and Local Levels of Lidocaine During Surgery for Glioblastoma
NCT04716699CI-TRIAL-00105108completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial measures the amount and effect of lidocaine injected into patients with glioblastoma while they are undergoing surgical removal of their brain tumors. Lidocaine is a substance used to relieve pain by blocking signals at the nerve endings in skin. Information gained from this study may help researchers come up with new treatments to help patients with glioblastomas in the future.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Lidocaine | Drug | — | UNRESOLVED |
| Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Health services research (lidocaine, surgery)
- description
- Patients receive bolus lidocaine IV per standard of care. After intubation, patients receive another infusion of lidocaine IV over 4 hours or until the end of surgery. Patients also undergo collection of blood and tumor samples at the start of surgery and hourly afterwards until a total of 4 samples are collected.
- interventionNames
- Procedure: Biospecimen Collection
- Drug: Lidocaine
- Procedure: Resection
Primary outcomes (1)
- measure
- Difference between the concentrations of lidocaine in the tumor tissue and in the blood (baseline level)
- timeFrame
- At start of surgery up until completion of surgery, assessed up to 4 hours after starting surgery
- description
- Analysis is mainly descriptive and will be mainly done by Lidocaine analysis lab. Will report the mean and standard deviation of concentration of lidocaine in the tumor and blood at 3 time points. The pharmacokinetics of lidocaine within the tumor will be summarized using the means, and standard pharmacokinetics parameters will be reported (maximum concentration, time of maximum concentration, and area under the curve). If applicable, will use mixed effects model to summarize trajectories of change for concentration measured at multiple time points, which will account for correlation between repeated measures within patient.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \>= 18 years of age * Preoperative imaging characteristics consistent with brain glioblastoma (magnetic resonance imaging \[MRI\] brain) * Patients who are undergoing neurosurgical resection for treatment of glioblastoma * Ability to understand and willingness to sign an informed consent form * Ability to adhere to the study visit schedule and other protocol requirements Exclusion Criteria: * Prior treatment for glioblastoma * Glioblastoma size less than 5 cm\^3 * Known allergy against amide type of local anesthetics * History of severe cardiac failure (determined by clinical history of less the 3 Metabolic Equivalent of Tasks \[METs\]) * 2nd or 3rd degree heart block (exception: patients with pacemaker) * Concurrent treatment with class I or III antiarrhythmics (phenytoin, procainamide, propranolol, quinidine) or amiodarone use =\< 3 months * History of Wolff-Parkinson-White syndrome, Stokes Adams syndrome, or active dysrhythmia * History of bradycardia * Prior clinical history of severe hepatic impairment or alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 1.55 times of upper normal limit * Prior clinical history of severe renal impairment or estimated glomerular filtration rate (EGFR) \< 30ml/min * Uncontrolled seizure disorder * Acute porphyria * Patients requiring an awake fiberoptic intubation due to administration of additional lidocaine * Pregnant or lactating women * Any condition that would prohibit the understanding or rendering of informed consent * Any medical condition including additional malignancies, laboratory abnormalities, or psychiatric illness that in the opinion of the investigator would prevent the subject from participating and adhering to study related procedures * Uncontrolled concomitant disease that in the opinion of the investigator would interfere with the patient's safety or compliance on trial
References
Publications (1)
- DERIVEDRiestenberg RA, Goodarzi A, Goodrich D, Clouse J, Ling S, Lechpammer M, Schloemerkemper N, Chen S, Chen Y, Bloch O, Shahlaie K. Pharmacokinetics of lidocaine infusion during surgery for glioblastoma. Clin Neurol Neurosurg. 2025 Dec;259:109218. doi: 10.1016/j.clineuro.2025.109218. Epub 2025 Oct 26. PMID 41177142