Clinical trial · Interventional
Lidocaine Infusion in Pancreatic Cancer
Lidocaine Infusion in Pancreatic Cancer: Translational Studies in a Preclinical Model And Human Subjects
NCT04048278CI-TRIAL-00114822recruitingEarly Phase 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 study elucidates the effects of the intravenous (IV) lidocaine infusion on the biology of pancreatic circulating tumor cells (CTCs) isolated from patients undergoing robotic pancreatectomy for all types of pancreatic cancer. A prospective randomized controlled double blinded trial design will be used for the proposed study.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lidocaine Hydrochloride | Drug | — | UNRESOLVED |
| Saline Solution for Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lidocaine Hydrochloride
- description
- The IV bolus and infusions of lidocaine to those patients assigned to the lidocaine group will be started in the operating room and will continue until 24 h later. The group receiving the lidocaine infusion will first be administered a 1.0 - 1.5 mg/kg loading infusion over 5 minutes followed by a 1.0 - 1.5 mg/kg/h infusion for 24 h
- interventionNames
- Drug: Lidocaine Hydrochloride
- type
- PLACEBO_COMPARATOR
- label
- Saline Solution for Injection
- description
- The group receiving the saline infusion will be administered an equivalent volume of saline infused over 5 min followed by a saline infusion at the same flow rate as that used in the lidocaine group for 24 h (1.0 - 1.5 mg/kg/hr)
- interventionNames
- Drug: Saline Solution for Injection
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Has histologically or cytologically confirmed adenocarcinoma of the pancreas that is considered resectable as well as other types of pancreatic cancer (malignant endocrine and exocrine tumors) 2. Has measurable disease, defined as at least 1 tumor that fulfills the criteria 3. Patients diagnosed with resectable cancer, but upon initial phase of surgical exploration found to have metastatic disease 4. Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Independent Ethics Committee (IRB/IEC) 5. Prior systemic treatments for metastatic disease are permitted, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy. Exclusion Criteria: 1. Has American Society of Anesthesiologists (ASA) physical status \> 3 2. Has hypersensitivity or allergy to amide-linked local anesthetics 3. Has a second or third degree heart block 4. Has severe sinoatrial block 5. Is currently being treated with any of the following class I antiarrhythmic drugs; quinidine, flecainide, disopyramide, or procainamide 6. Has been treated with amiodarone in the past 7. Has Adams-Stoke syndrome 8. Has Wolff-Parkinson-White syndrome 9. Has a history of blood clots, pulmonary embolism, or deep vein thrombosis unless controlled by anticoagulant treatment 10. Has a known history of human immunodeficiency virus (HIV) positivity or untreated and uncontrolled hepatitis B or C
References
Publications (4)
- BACKGROUNDShakhar G, Ben-Eliyahu S. Potential prophylactic measures against postoperative immunosuppression: could they reduce recurrence rates in oncological patients? Ann Surg Oncol. 2003 Oct;10(8):972-92. doi: 10.1245/aso.2003.02.007. PMID 14527919
- BACKGROUNDMokbel K, Choy C, Engledow A. The effect of surgical wounding on tumour development. Eur J Surg Oncol. 2000 Mar;26(2):195. doi: 10.1053/ejso.1999.0771. No abstract available. PMID 10744945
- BACKGROUNDMissair A, Cata JP, Votta-Velis G, Johnson M, Borgeat A, Tiouririne M, Gottumukkala V, Buggy D, Vallejo R, Marrero EB, Sessler D, Huntoon MA, Andres J, Casasola OL. Impact of perioperative pain management on cancer recurrence: an ASRA/ESRA special article. Reg Anesth Pain Med. 2019 Jan;44(1):13-28. doi: 10.1136/rapm-2018-000001. PMID 30640648
- BACKGROUNDHan L, Chen W, Zhao Q. Prognostic value of circulating tumor cells in patients with pancreatic cancer: a meta-analysis. Tumour Biol. 2014 Mar;35(3):2473-80. doi: 10.1007/s13277-013-1327-5. Epub 2013 Nov 12. PMID 24218336