Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
46 participants
INTERVENTIONAL
2018-11-08
2026-01-01
Brief Summary
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A prospective randomized controlled double blinded trial design will be used for the proposed study.
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Detailed Description
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A prospective randomized controlled double blinded trial design will be used for the proposed study.
Patients undergoing robotic pancreatectomy for pancreatic cancer will be randomized (ratio 1:1) into two groups: one group will receive a 24-h normal saline infusion and the second group will receive a 24-h lidocaine infusion. Blood samples will be collected in different times perioperatively in order to evaluate the objectives of the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lidocaine Hydrochloride
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
Lidocaine Hydrochloride
IV Lidocaine a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
Saline Solution for Injection
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)
Saline Solution for Injection
IV Saline a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
Interventions
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Lidocaine Hydrochloride
IV Lidocaine a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
Saline Solution for Injection
IV Saline a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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University of Illinois at Chicago
OTHER
Responsible Party
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Effrossyni Votta-Velis
Associate Professor
Principal Investigators
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Gina E. Votta-Velis, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Associate Professor
Locations
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University of Illnois at Chicago
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Shakhar 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.
Mokbel 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.
Missair 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.
Han 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.
Other Identifiers
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2017-1365
Identifier Type: -
Identifier Source: org_study_id
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