- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03824808
Effect of Perioperative Intravenous Lidocaine Infusion in Robotic-Assisted Urologic Surgery
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Katie Murray, DO
- Phone Number: 573-884-4057
- Email: murraykat@health.missouri.edu
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65212
- University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment group
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:
|
Placebo Comparator: Control group
0.9% Sodium Chloride Injection
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Sodium Chloride Injection USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Post-operative Pain Scores Measured by Visual Analog Scale
Time Frame: 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.
|
10-cm Visual Analog Scale (VAS), score of 0 "no pain" to a score of 10 "worst pain ever"
|
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid Consumption
Time Frame: Through study completion, assessed for first 24-hours post operatively, then every 24 hours until discharge, and at the post operative visit which occurred within 21-days post-operatively.
|
Difference in opioid consumption in first 24 hours, discharge and 21 days post-operatively (morphine equivalents)
|
Through study completion, assessed for first 24-hours post operatively, then every 24 hours until discharge, and at the post operative visit which occurred within 21-days post-operatively.
|
Length of Hospital Stay
Time Frame: 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
|
At participant discharge, assessed up to 14 days (+/-) 7 days
|
Duration of Post-operative Ileus
Time Frame: 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.
|
Difference in post-operative Ileus duration
|
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.
|
Post-operative PACU Time
Time Frame: During hospitalization, approximately 2 hours post-surgery
|
Difference in time in the Post Anesthesia Care Unit (PACU) after surgery
|
During hospitalization, approximately 2 hours post-surgery
|
Return of Flatus
Time Frame: During hospitalization at 1h, 2h, 4h, 6h, 12h, and 24h post operatively, then every 24 hours thereafter until discharge.
|
Difference in return of flatus after surgery
|
During hospitalization at 1h, 2h, 4h, 6h, 12h, and 24h post operatively, then every 24 hours thereafter until discharge.
|
Time to Out of Bed
Time Frame: During hospitalization regular intervals for the first 24 hours, then every 24 hours until discharge.
|
Difference in time to out of bed to chair after surgery
|
During hospitalization regular intervals for the first 24 hours, then every 24 hours until discharge.
|
First Ambulation in the Hallway
Time Frame: During hospitalization at 1h, 2h, 4h, 6h, 12h, and 24h post operatively, then every 24 hours until discharge.
|
Difference in time to first ambulation in the hallway after surgery
|
During hospitalization at 1h, 2h, 4h, 6h, 12h, and 24h post operatively, then every 24 hours until discharge.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Boris Mraovic, MD, University of Missouri-Columbia
Publications and helpful links
General Publications
- Bates C, Laciak R, Southwick A, Bishoff J. Overprescription of postoperative narcotics: a look at postoperative pain medication delivery, consumption and disposal in urological practice. J Urol. 2011 Feb;185(2):551-5. doi: 10.1016/j.juro.2010.09.088. Epub 2010 Dec 18.
- Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers---United States, 1999--2008. MMWR Morb Mortal Wkly Rep. 2011 Nov 4;60(43):1487-92.
- Woldu SL, Weinberg AC, Bergman A, Shapiro EY, Korets R, Motamedinia P, Badani KK. Pain and analgesic use after robot-assisted radical prostatectomy. J Endourol. 2014 May;28(5):544-8. doi: 10.1089/end.2013.0783. Epub 2014 Jan 30.
- Hedegaard H, Warner M, Minino AM. Drug Overdose Deaths in the United States, 1999-2016. NCHS Data Brief. 2017 Dec;(294):1-8.
- Dunn LK, Durieux ME. Perioperative Use of Intravenous Lidocaine. Anesthesiology. 2017 Apr;126(4):729-737. doi: 10.1097/ALN.0000000000001527. No abstract available.
- De Oliveira GS Jr, Fitzgerald P, Streicher LF, Marcus RJ, McCarthy RJ. Systemic lidocaine to improve postoperative quality of recovery after ambulatory laparoscopic surgery. Anesth Analg. 2012 Aug;115(2):262-7. doi: 10.1213/ANE.0b013e318257a380. Epub 2012 May 14.
- Joshi GP, Jaschinski T, Bonnet F, Kehlet H; PROSPECT collaboration. Optimal pain management for radical prostatectomy surgery: what is the evidence? BMC Anesthesiol. 2015 Nov 4;15:159. doi: 10.1186/s12871-015-0137-2.
- Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002 Jun;3(3):159-80. doi: 10.1054/jpai.2002.123652. No abstract available.
- Marcus HJ, Hughes-Hallett A, Payne CJ, Cundy TP, Nandi D, Yang GZ, Darzi A. Trends in the diffusion of robotic surgery: A retrospective observational study. Int J Med Robot. 2017 Dec;13(4):e1870. doi: 10.1002/rcs.1870. Epub 2017 Nov 6.
- Choi JE, You JH, Kim DK, Rha KH, Lee SH. Comparison of perioperative outcomes between robotic and laparoscopic partial nephrectomy: a systematic review and meta-analysis. Eur Urol. 2015 May;67(5):891-901. doi: 10.1016/j.eururo.2014.12.028. Epub 2015 Jan 6.
- Avulova S, Smith JA Jr. Is Comparison of Robotic to Open Radical Prostatectomy Still Relevant? Eur Urol. 2018 May;73(5):672-673. doi: 10.1016/j.eururo.2018.01.011. Epub 2018 Feb 3. No abstract available.
- D'Alonzo RC, Gan TJ, Moul JW, Albala DM, Polascik TJ, Robertson CN, Sun L, Dahm P, Habib AS. A retrospective comparison of anesthetic management of robot-assisted laparoscopic radical prostatectomy versus radical retropubic prostatectomy. J Clin Anesth. 2009 Aug;21(5):322-8. doi: 10.1016/j.jclinane.2008.09.005. Epub 2009 Aug 22.
- Batley SE, Prasad V, Vasdev N, Mohan-S G. Post-Operative Pain Management in Patients Undergoing Robotic Urological Surgery. Curr Urol. 2016 Feb;9(1):5-11. doi: 10.1159/000442843. Epub 2016 Feb 10.
- Jendoubi A, Naceur IB, Bouzouita A, Trifa M, Ghedira S, Chebil M, Houissa M. A comparison between intravenous lidocaine and ketamine on acute and chronic pain after open nephrectomy: A prospective, double-blind, randomized, placebo-controlled study. Saudi J Anaesth. 2017 Apr-Jun;11(2):177-184. doi: 10.4103/1658-354X.203027.
- Naik BI, Tsang S, Knisely A, Yerra S, Durieux ME. Retrospective case-control non-inferiority analysis of intravenous lidocaine in a colorectal surgery enhanced recovery program. BMC Anesthesiol. 2017 Jan 31;17(1):16. doi: 10.1186/s12871-017-0306-6.
- Nakhli MS, Kahloul M, Guizani T, Zedini C, Chaouch A, Naija W. Intravenous lidocaine as adjuvant to general anesthesia in renal surgery. Libyan J Med. 2018 Dec;13(1):1433418. doi: 10.1080/19932820.2018.1433418.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- 2012402
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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