Effect of Perioperative Intravenous Lidocaine Infusion in Robotic-Assisted Urologic Surgery

In recent years, the risk of opioids in the post-operative period has gained interest due to
the growing epidemic of addiction, dependence, and overdose. The rate of drug overdose
secondary to opioids has continued to increase at an alarming rate. This has been a primary
point of concern in all fields of medicine and Urology has not been an exception. This is
also a nationwide government and public health concern. This has generated an increased focus
on the use of non-opioid analgesics after surgery such as intravenous lidocaine.

Opioids remain the primary source of relief for postoperative pain and have the potential to
lead to significant morbidity. Opioids may delay recovery following surgery and have many
well-known adverse effects including, but not limited to, nausea, vomiting and prolonged
post-operative ileus. Furthermore, in one study, they inadequately provided pain control in
50-60% of postoperative participants. This is a frequent report of participants because of
the less than optimal utilization of the medications in fear of their dose dependent adverse
effects and various contraindications. On the other hand, surplus medication following
surgery is another prominent component of the opioid problem in Urologic practices. Bates et
al. found that of the 586 participants that underwent a urological procedure that they
reviewed, 67% of them had collected surplus medication. It is both necessary and beneficial
for surgeons and participants to utilize dose-sparing strategies following surgery to
decrease overall opioid usage and outpatient requirement.

One mechanism that has already been employed for overall improvement in prostatectomies and
partial nephrectomies is the use of the robotic assisted approach. Robot assisted partial
nephrectomies (RALPN) and robotic assisted laparoscopic prostatectomies (RALP) are becoming a
mainstay in urologic surgery and increasing annually. This coincides with a continuous
downward trend of laparoscopic and open urologic procedures. RALPN has been shown in a
meta-analysis to be more favorable than laparoscopic partial nephrectomies and will continue
to be the surgical procedure of choice in the near future. RALP is also now the dominant
surgical approach while open and laparoscopic prostatectomies becoming less frequent. Robotic
assisted surgery is associated with improved functional outcomes, pain scores, shorter
hospital stays, and increases in participants satisfaction in many studies.

While there has been a pronounced increase in robotic surgery over the past 10 years that has
demonstrated benefits for participants, there has been limited studies regarding the pain
management for these participants. Robotic assisted surgery itself decreases pain levels
compared to other approaches, but participants continue to experience mild to moderate pain
levels in the postoperative period, which are classically managed with NSAIDs and opioids.

Recently, Enhanced Recovery after Surgery protocols (ERAS) have been implemented in an
attempt to decrease pain and opioid use as one outcome. ERAS utilizes multimodal analgesia
and has shown improvement of participant satisfaction and perioperative opioid use. Systemic
lidocaine is becoming more popular and regularly applied through this protocol and, other
practices, in due to its analgesic, anti-hyperalgesia and anti-inflammatory properties that
it contains. Systemic lidocaine mechanism of action is not fully understood, but it appears
to be multifaceted. Systemic lidocaine inhibits voltage-gated sodium channels in both the
peripheral and central nervous system. This is believed to cause an additive effect when
combined with inhaled anesthetics which also work on the voltage-gated sodium channels in the
central nervous system. Despite this summative effect, this is likely not the primary
mechanism of action. Instead, it is believed to predominantly act on anti-inflammatory
signaling and through inhibiting neuronal effects. Additionally, it reduces nociception and
cardiovascular response to surgical stress and pain.

This is a prospective, randomized, double-blinded, placebo-controlled clinical trial on
lidocaine infusion for pain control and opioid consumption in participants undergoing either
robotic-assisted laparoscopic prostatectomy or robotic-assisted laparoscopic partial
nephrectomy at University of Missouri Hospital. Participants will be randomized in a 1:1
fashion and stratified by the type of surgery to receive a perioperative intravenous 0.8%
lidocaine infusion at 1 mg/kg/h if < age 65 and 0.5 mg/kg/h if ≥ age 65 or an equal volume
and rate of normal saline as a placebo. The infusion will be started 15 minutes after
endotracheal intubation and continue for 24 hours.

The study that the investigators propose targets an area of urology that is underrepresented
in the current literature despite its increasing importance. To the best of the
investigator's knowledge, this has not been directly studied before, although it has been
utilized numerous times in the ERAS protocol at the University of Missouri Hospital
throughout the Division of Urology and Anesthesiology & Perioperative Medicine in
participants undergoing robotic surgery. The benefits of intravenous lidocaine have been
demonstrated in other areas and these results warrant a prospective, randomized,
double-blinded, placebo controlled study to assess the lidocaine infusion effects for robot
assisted laparoscopic prostatectomies and partial nephrectomies. As the number of robotic
assisted surgeries and emphasis on opioid reduction continues, the evaluation of systemic
lidocaine will be important in improving outcomes in urology.

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