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

NCT03824808 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2012402
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Cancer; Prostate Cancer

Keywords

prostatectomy; partial nephrectomy; robotic surgery; intravenous lidocaine; lidocaine hydrochloride

Outcome Measures

Primary Outcomes (1)

• Difference in Post-operative Pain Scores Measured by Visual Analog Scale

  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 Outcomes (7)

• Opioid Consumption

  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

  At participant discharge, assessed up to 14 days (+/-) 7 days

• Duration of Post-operative Ileus

  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

  During hospitalization, approximately 2 hours post-surgery

• Return of Flatus

  During hospitalization at 1h, 2h, 4h, 6h, 12h, and 24h post operatively, then every 24 hours thereafter until discharge.

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

Lidocaine Hydrochloride 0.8% in Dextrose 5% Solution

Drug: Lidocaine Hydrochloride 0.8% in Dextrose 5% Solution

Control group

PLACEBO COMPARATOR

0.9% Sodium Chloride Injection

Drug: 0.9% Sodium Chloride Injection

Interventions

Lidocaine Hydrochloride 0.8% in Dextrose 5% Solution DRUG

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

Also known as: Lidocaine

Treatment group

0.9% Sodium Chloride Injection DRUG

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

Also known as: Normal Saline

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University Hospital

Columbia, Missouri, 65212, United States

Location

Related Publications (16)

• 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.

  PMID: 21168869 BACKGROUND

• Hedegaard H, Warner M, Minino AM. Drug Overdose Deaths in the United States, 1999-2016. NCHS Data Brief. 2017 Dec;(294):1-8.

  PMID: 29319475 BACKGROUND

• 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.

  PMID: 22048730 BACKGROUND

• Dunn LK, Durieux ME. Perioperative Use of Intravenous Lidocaine. Anesthesiology. 2017 Apr;126(4):729-737. doi: 10.1097/ALN.0000000000001527. No abstract available.

  PMID: 28114177 BACKGROUND

• 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.

  PMID: 22584558 BACKGROUND

• 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.

  PMID: 26530113 BACKGROUND

• 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.

  PMID: 14622770 BACKGROUND

• 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.

  PMID: 29105982 BACKGROUND

• 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.

  PMID: 25572825 BACKGROUND

• 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.

  PMID: 29398264 BACKGROUND

• 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.

  PMID: 19700296 BACKGROUND

• 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.

  PMID: 26989364 BACKGROUND

• 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.

  PMID: 24400824 BACKGROUND

• 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.

  PMID: 28442956 BACKGROUND

• 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.

  PMID: 28143397 BACKGROUND

• 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.

  PMID: 29433385 BACKGROUND

MeSH Terms

Conditions

Kidney Neoplasms; Prostatic Neoplasms

Interventions

Lidocaine; Glucose; Solutions; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hexoses; Monosaccharides; Sugars; Carbohydrates; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions

Results Point of Contact

• Title: Dr Boris Mraovic
• Organization: University of Missouri

mraovicb@health.missouri.edu

5738822568

Study Officials

• Boris Mraovic, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Anesthesiology

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: January 31, 2019
• Study Start: February 26, 2019
• Primary Completion: March 26, 2020
• Study Completion: March 26, 2020
• Last Updated: October 25, 2023
• Results First Posted: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)