Intravenous Lidocaine for Cystectomy Procedures (Lidocaine)

Intravenous Lidocaine in the Perioperative Setting and the Effects on Postoperative Pain and Bowel Function Following Cystectomy: A Pilot Study

Patients scheduled for a cystectomy at Charleston Area Medical Center (CAMC) will be enrolled into a randomized, double blinded clinical trial to assess if postoperative pain and ileus are reduced by perioperative intravenous lidocaine infusion versus placebo. The hypothesis is that patients receiving the lidocaine infusion will experience better pain control and ileus resolution. It is believed that lidocaine patients will also have less opioid requirement, less mortality, a shorter length of stay, less nausea /vomiting, and fewer adverse events.

Study Overview

• Status: Completed
• Conditions: Invasive Bladder Cancer
• Intervention / Treatment: Procedure: Cystectomy; Drug: Lidocaine; Drug: Saline

Detailed Description

Design

The design will be a randomized, double blinded, single institute prospective study with patients undergoing Open or Robotic Assisted cystectomy procedures at Charleston Area Medical Center in Charleston, West Virginia. All patients following informed consent that meet the inclusion criteria are eligible to participate in the study.

Procedures and Protocol

This study will have two groups. Each group will follow a standardized post cystectomy protocol to reduce confounding factors in regards to postoperative management.

Study Group

Group A: The lidocaine infusion group will receive the lidocaine bolus 30 minutes prior to skin incision and the infusion will continue until 60 minutes after skin closure.

Control Group

Group B: Patients will be randomized to the control group and receive a normal saline bolus and infusion in the same procedure as the study arm.

All patients in both groups will have pain scores documented at the time of the surgery. A baseline level of abdominal pain will be assessed using a 0 to 10 verbal analog scale (VAS), in which a rating of "0" indicates "no pain" and a score of "10" indicates the "worst pain imaginable". This data, which is the baseline preoperative pain score, will be used by statistician for data analysis.

After surgery, nursing staffs will record the exact time the patient passes first flatus and have first bowel movements; nurses will also routinely asked each patients of these bowel activities during the patient assessments. Postoperative nausea and/or vomiting will be assessed in a similar fashion by the nursing staff. From Postoperative Day 1 until discharge (or up to 108 hours), at specified time intervals patients will be asked to score the average pain on a scale of O-10 (0 = none; 10 = worst pain imaginable) and any nausea/vomiting was experienced. The numeric rating scale is being used in this study because it is used commonly in patients post-operatively and due to its common use in other pain assessment studies. This information along with medication use during the same time intervals will be recorded by the nursing staffs at Charleston Area Medical Center.

The American Pain Society Patient Outcome Questionnaire (APS-POQ-R) will be used to assess pain management during the first 24 hours after surgery. This questionnaire measures six aspects of pain including: pain severity and relief; impact of pain on activity, sleep, and negative emotions; side effects of treatment; helpfulness of information about pain treatment; ability to participate in pain treatment decisions; and use of nonpharmacological strategies. This has been validated in multiple studies to assess pain of patients and can be used in reference to other literature in regards to pain management previously published.

In order to compare each arm for primary outcomes, namely improved pain control, decreased opioid consumption, and improved resolution of ileus, a descriptive analysis will be performed with means, standard deviations, ranges and percentages being reported for the prospective variables. In addition subgroup analysis will be conducted using statistical tests between study and control group to examine the differences between medication use, pain relief satisfaction, and post procedure pain scores. Continuous variables will be analyzed using the Student's t-test and categorical variables using chi-square or Fisher's Exact Test. Logistic regression will be used if needed to determine if any the variables are associated with study group. A p < 0.05 will be considered statistically significant.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Charleston, West Virginia, United States, 25301
      • Urology center of charleston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any patient undergoing a cystectomy with an American Society of Anesthesiologists physical status classification (ASA) of 1 or 2.

Exclusion Criteria:

• Any patients with a history of substance abuse, allergy to amides, and current treatment with antiarrhythmic medications (due to lidocaine being a class 1b antiarrhythmic agent) will be excluded.
• Patients will also be excluded if they are pregnant or have a history of chronic pain syndrome, chronic bowel or liver dysfunction.
• Patients with chronic opioid use, and therefore opioid tolerance, and history of opioid addiction will also be excluded due to likely increased opioid needs for equivalent pain control.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lidocaine Study Group; Intravenous Lidocaine for Cystectomy Procedures: During the surgery, the lidocaine infusion group will receive the lidocaine bolus (1.5mg/kg bolus followed by a 2mg/kg/h infusion) 30 minutes prior to skin incision and the infusion will continue until 60 minutes after skin closure.	Procedure: Cystectomy; Drug: Lidocaine; Patients will receive lidocaine infusion during surgery
Placebo Comparator: Placebo Study Group; Intravenous Saline for Cystectomy Procedures: During the surgery, patients will be randomized to the control group and receive a normal saline bolus 30 minutes prior to skin incision and the infusion will continue until 60 minutes after skin closure.	Procedure: Cystectomy; Drug: Saline; Patients will receive saline infusion during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced pain post-operatively using verbal analog score	Use verbal analog score to assess patients pain and compare between study and control groups. This will determine if patients in the lidocaine study arm experience less pain than those in the placebo group.	108 hours after surgery
Time until Ileus resolution	Time to ileus resolution will be compared between study and control groups using the end of surgery time to the time of first bowl movement. This should determine if those in the lidocaine study arm experience quicker Ileus resolution compared to those in the placebo study arm.	108 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain management during the first 24 hours after surgery using the American Pain Society Patient Outcome Questionnaire (APS-POQ-R)	The American Pain Society Patient Outcome Questionnaire (APS-POQ-R) will be used to assess pain management during the first 24 hours after surgery. This questionnaire measures six aspects of pain including: pain severity and relief; impact of pain on activity, sleep, and negative emotions; side effects of treatment; helpfulness of information about pain treatment; ability to participate in pain treatment decisions; and use of nonpharmacological strategies. These results will be compared between the lidocaine study group and the placebo study group to determine if the lidocaine study group experienced better pain management within the first 24 hours after surgery.	24 hours post-operatively

Collaborators and Investigators

• Sponsor: CAMC Health System
• Investigators: Principal Investigator: Samuel G Deem, DO, CAMC Health System

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2016
• Primary Completion (Actual): June 17, 2020
• Study Completion (Actual): June 17, 2020

Study Registration Dates

• First Submitted: October 3, 2016
• First Submitted That Met QC Criteria: October 4, 2016
• First Posted (Estimate): October 5, 2016

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: cystectomy; invasive bladder cancer; high grade bladder cancer
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder 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: 16-247

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED