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 range18 Years

SexALL

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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

What they're measuring

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.

Trial details

NCT IDNCT03824808

SponsorUniversity of Missouri-Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-26

Results submitted2023-07-10