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.
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.
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.
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.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||Start Date: August 2016||N/A||Interventional|
Primary Outcome 1 - Measure: Reduced pain post-operatively using verbal analog score
Primary Outcome 1 - Time Frame: 108 hours after surgery
Primary Outcome 2 - Measure: Time until Ileus resolution
Primary Outcome 2 - Time Frame: 108 hours after surgery
- Any patient undergoing a cystectomy with an American Society of Anesthesiologists
physical status classification (ASA) of 1 or 2.
- 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.
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: Accepts Healthy Volunteers
Name: Samuel G Deem, DO
Role: Principal Investigator
Affiliation: CAMC Health System
Name: Samuel G Deem, DO
|Urology center of charleston
Charleston, West Virginia 25301
Samuel Deem, D.O.