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

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ClinicalTrials.gov Identifier: NCT03824808
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Katie Murray, University of Missouri-Columbia

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : February 26, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2021


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 Name: 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 Name: Normal Saline




Primary Outcome Measures :
  1. Difference in post-operative pain scores measured by Visual Analog Scale [ Time Frame: 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 :
  1. Opioid consumption [ Time Frame: 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)

  2. 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

  3. Duration of post-operative Ileus [ Time Frame: During hospitalization, assessed up to 14 days (+/-) 7 days ]
    Difference in post-operative Ileus duration

  4. 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

  5. Return of flatus [ Time Frame: During hospitalization, assessed up to 14 days (+/-) 7 days ]
    Difference in return of flatus after surgery

  6. Time to out of bed [ Time Frame: During hospitalization, assessed up to 14 days (+/-) 7 days ]
    Difference in time to out of bed to chair after surgery

  7. First ambulation in the hallway [ Time Frame: During hospitalization, assessed up to 14 days (+/-) 7 days ]
    Difference in time to first ambulation in the hallway after surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824808


Contacts
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Contact: Katie Murray, DO 573-884-4057 murraykat@health.missouri.edu
Contact: Boris Mraovic, MD 573-882-2568 mraovicb@health.missouri.edu

Locations
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United States, Missouri
University Hospital Recruiting
Columbia, Missouri, United States, 65212
Contact: Katie Murray, DO    573-884-4057    murraykat@health.missouri.edu   
Contact: Boris Mraovic, MD    573-882-2568    mraovicb@health.missouri.edu   
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Katie Murray, DO University of Missouri-Columbia

Publications:

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Responsible Party: Katie Murray, Assistant Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03824808     History of Changes
Other Study ID Numbers: IRB # 2012402
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Katie Murray, University of Missouri-Columbia:
prostatectomy
partial nephrectomy
robotic surgery
intravenous lidocaine
lidocaine hydrochloride

Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action