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

Sponsor

University of Missouri-Columbia (Other)

Overall Status

Recruiting

CT.gov ID

NCT03824808

Collaborator

(none)

Enrollment

Location

Arms

47.1

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer Prostate Cancer	Drug: Lidocaine Hydrochloride 0.8% in Dextrose 5% Solution Drug: 0.9% Sodium Chloride Injection	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will receive either intraoperative 0.8% lidocaine or normal saline at 1 mg/kg/h when younger than 65 years and 0.5 mg/kg/h when greater than or equal to the age of 65 to be delivered by continuous infusion for 24 hours.Participants will receive either intraoperative 0.8% lidocaine or normal saline at 1 mg/kg/h when younger than 65 years and 0.5 mg/kg/h when greater than or equal to the age of 65 to be delivered by continuous infusion for 24 hours.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

The surgeon, anesthesiologist, operating room staff, participant, personnel in the postanesthesia care unit (PACU) as well as the investigators collecting the postoperative data will be blinded to the group allocation. Study medication is prepared and masked by an unblinded investigation drug pharmacist who is not involved in clinical care.

Primary Purpose:

Treatment

Official Title:

A Prospective, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial Evaluating the Use of Perioperative Intravenous Lidocaine Infusion to Decrease Pain Scores and Opioid Consumption After Robotic-Assisted Prostatectomy and Robotic-Assisted Partial Nephrectomy

Actual Study Start Date :

Feb 26, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment group Lidocaine Hydrochloride 0.8% in Dextrose 5% Solution	Drug: Lidocaine Hydrochloride 0.8% in Dextrose 5% Solution Lidocaine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution prepared from lidocaine hydrochloride and dextrose in water for injection. Other Names: Lidocaine
Placebo Comparator: Control group 0.9% Sodium Chloride Injection	Drug: 0.9% Sodium Chloride Injection Sodium Chloride Injection USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. Other Names: Normal Saline

Arm

Intervention/Treatment

Active Comparator: Treatment group

Lidocaine Hydrochloride 0.8% in Dextrose 5% Solution

Drug: Lidocaine Hydrochloride 0.8% in Dextrose 5% Solution

Lidocaine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution prepared from lidocaine hydrochloride and dextrose in water for injection.

Other Names:

Lidocaine

Placebo Comparator: Control group

0.9% Sodium Chloride Injection

Drug: 0.9% Sodium Chloride Injection

Sodium Chloride Injection USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents.

Other Names:

Normal Saline

Outcome Measures

Primary Outcome Measures

Difference in post-operative pain scores measured by Visual Analog Scale [Through study completion, assessed up to 14 days (+/-) 7 days]
10-cm Visual Analog Scale (VAS), score of 0 "no pain" to a score of 10 "worst pain ever"

Secondary Outcome Measures

Opioid consumption [Through study completion, assessed up to 14 days (+/-) 7 days]
Difference in opioid consumption in first 24 hours, discharge and 14 days post-operatively (morphine equivalents)
Length of hospital stay [At participant discharge, assessed up to 14 days (+/-) 7 days]
Difference in length of hospital stay determined by surgeon excluding social factors that may delay discharge
Duration of post-operative Ileus [During hospitalization, assessed up to 14 days (+/-) 7 days]
Difference in post-operative Ileus duration
Post-operative PACU time [During hospitalization, approximately 2 hours post-surgery]
Difference in time in the Post Anesthesia Care Unit (PACU) after surgery
Return of flatus [During hospitalization, assessed up to 14 days (+/-) 7 days]
Difference in return of flatus after surgery
Time to out of bed [During hospitalization, assessed up to 14 days (+/-) 7 days]
Difference in time to out of bed to chair after surgery
First ambulation in the hallway [During hospitalization, assessed up to 14 days (+/-) 7 days]
Difference in time to first ambulation in the hallway after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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