Invasive Bladder CancerLidocaineNCT02924480
Intravenous Lidocaine for Cystectomy Procedures
A study testing Cystectomy, Lidocaine and Saline in people with Invasive Bladder Cancer, run by CAMC Health System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Invasive Bladder Cancer
- What is being tested?
- Cystectomy, Lidocaine and Saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2016to 17 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient undergoing a cystectomy with an American Society of Anesthesiologists physical status classification (ASA) of 1 or 2.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Urology center of charleston
Charleston, West Virginia, 25301
About this study
Official title: 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.
Read the 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.
- Conditions
- Invasive Bladder Cancer
- Being tested
- Cystectomy, Lidocaine, Saline
- Keywords
- invasive bladder cancer, cystectomy, high grade bladder cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CystectomyProcedure or surgery
LidocaineDrug
Patients will receive lidocaine infusion during surgery
SalineDrug
Patients will receive saline infusion during surgery
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Study Group | Active comparator | 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. Receives: Procedure: Cystectomy; Drug: Lidocaine |
| Placebo Study Group | Placebo comparator | 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. Receives: Procedure: Cystectomy; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 108 hours after surgery
Secondary outcomes (1)
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.
Measured: 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start12 Oct 2016
- Primary completion17 Jun 2020
- Study completion17 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Deem, DO, CAMC Health System
- Investigators
- Samuel G Deem, DO, Principal investigator, CAMC Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924480
- Sponsor's protocol ID
- 16-247
- Acronym
- Lidocaine
- Status last verified
- Mar 2022
- First submitted
- 3 Oct 2016
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Lidocaine in the Perioperative Setting and the Effects on Postoperative Pain and Bowel Function Following Cystectomy: A Pilot Study
- ClinicalTrials.gov ID
- NCT02924480
- Acronym / sponsor ID
- Lidocaine / 16-247
- Conditions
- Invasive Bladder Cancer
- Keywords
- invasive bladder cancer, cystectomy, high grade bladder cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Study start
- 12 Oct 2016 (actual)
- Primary completion
- 17 Jun 2020 (actual)
- Study completion
- 17 Jun 2020 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Study Group | Active comparator | Procedure: Cystectomy, Drug: LidocaineIntravenous 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. |
| Placebo Study Group | Placebo comparator | Procedure: Cystectomy, Drug: SalineIntravenous 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient undergoing a cystectomy with an American Society of Anesthesiologists physical status classification (ASA) of 1 or 2.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cystectomy | Procedure or surgery | Lidocaine Study Group, Placebo Study Group |
| LidocainePatients will receive lidocaine infusion during surgery | Drug | Lidocaine Study Group |
| SalinePatients will receive saline infusion during surgery | Drug | Placebo Study Group |
Primary outcome
Reduced pain post-operatively using verbal analog score
Time frame: 108 hours after surgery
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.
Time until Ileus resolution
Time frame: 108 hours after surgery
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.
1 secondary outcome
Pain management during the first 24 hours after surgery using the American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
Time frame: 24 hours post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Invasive Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
Non-muscle Invasive Bladder Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingPhase 1
FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
Urinary Bladder Neoplasms, Neoplasm Metastasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel G Deem, DO principal investigator
CAMC Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cystectomy, Lidocaine and Saline in people with Invasive Bladder Cancer, run by CAMC Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced pain post-operatively using verbal analog score (time frame: 108 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.