Effect of Perioperative Intravenous Lidocaine Infusion in Robotic-Assisted Urologic Surgery (NCT03824808) | Clinical Trial Compass
TerminatedPhase 4
Effect of Perioperative Intravenous Lidocaine Infusion in Robotic-Assisted Urologic Surgery
Stopped: Challenges with recruitment of surgical research subjects in the target population.
United States21 participantsStarted 2019-02-26
Plain-language summary
Controlling pain is fundamental during and after surgical procedures. This study examines pain associated with robotic assisted surgery on prostate cancer or a kidney mass. In recent years, the risk of opioids in the postoperative period has gained interest due to the growing epidemic of addiction, dependence, and overdose. In this study, the investigators expect a continuous infusion of intravenous lidocaine during the perioperative period to result in less pain and less opioid use.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Undergoing robotic assisted prostatectomy or robotic assisted partial nephrectomy at University of Missouri Hospital for prostate cancer or kidney mass
* Age ≥ 18 years
* ASA I-III
Exclusion Criteria:
* Inability to obtain written informed consent
* Allergy to lidocaine or other amide local anesthetics
* Atrioventricular conduction blocks
* CV instability and concomitant use of alpha agonists or beta blockers
* Recent myocardial infarction (≤ 6 months ago)
* Cardiac arrhythmia disorders
* Stokes-Adams syndrome
* Wolff-Parkinson-White syndrome
* Seizure disorders
* Liver failure or hepatic dysfunction
* Significant renal disease with a serum creatinine ≥ 2 mg/dl
* A family history of malignant hyperthermia
* Current use of opioids or documented history of opioid abuse
* Typically, have less than 3 bowel movement per week
* Combined surgical cases that include robotic prostatectomy or robotic partial nephrectomy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in Post-operative Pain Scores Measured by Visual Analog Scale
Timeframe: Through study completion, assessed at 1h, 2h, 4h, 6h, 12h and 24h post operatively, then every 24 hours until discharge, and at the post operative visit which occurred within 21-days post-operatively.