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Continuous Infusion of Ropivacaine Hydrochloride in Reducing Pain After Surgery in Patients With Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02438852
Recruitment Status : Withdrawn (No funding)
First Posted : May 8, 2015
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Tracking Information
First Submitted Date  ICMJE May 6, 2015
First Posted Date  ICMJE May 8, 2015
Last Update Posted Date April 16, 2019
Estimated Study Start Date  ICMJE February 25, 2019
Estimated Primary Completion Date February 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2017)		 Narcotic requirement [ Time Frame: Up to 72 hours after surgery ]
Total narcotic dose after surgery until 72 hours will be analyzed as continuous variables and will be compared with the one sided t-test in an intention-to-treat manner.
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
  • Narcotic requirement [ Time Frame: Up to 72 hours after surgery ]
    Total narcotic dose after surgery until 72 hours will be analyzed as continuous variables and will be compared with the one sided t-test in an intention-to-treat manner.
  • Visual Analog Scale (VAS) pain scores (0-10) [ Time Frame: Up to 72 hours after surgery ]
    Assessed by blinded study personnel with the patient at rest at 4 hours, 24 hours, 48 hours and 72 hours after surgery. The four VAS scores for each patient will be added to arrive at a cumulative VAS score. The VAS score will be analyzed as continuous variables and will be compared with the one sided t-test in an intention-to-treat manner.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2017)		 Length of hospitalization [ Time Frame: Up to 30 days after surgery ]
The length of hospitalization will be analyzed as continuous variables and will be compared with the one sided t-test in an intention-to-treat manner.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
  • Length of hospitalization [ Time Frame: Up to 30 days after surgery ]
    The length of hospitalization will be analyzed as continuous variables and will be compared with the one sided t-test in an intention-to-treat manner.
  • Patient satisfaction with postoperative pain control [ Time Frame: Up to 14 days ]
    The patient satisfaction outcome will measure the number of patients who rated their postoperative pain control as 'excellent'.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Continuous Infusion of Ropivacaine Hydrochloride in Reducing Pain After Surgery in Patients With Bladder Cancer
Official Title  ICMJE Efficacy of Continuous Infusion of Local Anesthesia After Radical Cystectomy: A Randomized, Double Blind, Placebo Controlled Study
Brief Summary This randomized phase IV trial studies how well the continuous infusion of ropivacaine hydrochloride works in reducing pain after surgery in patients with bladder cancer. Ropivacaine hydrochloride is an anesthetic drug used to decrease pain by numbing an area of the body without putting the patient to sleep. Continuous infusion of ropivacaine hydrochloride may reduce pain and improve the quality of life for patients after bladder surgery.
Detailed Description

PRIMARY OBJECTIVES:

I. To determine if continuous infusion of local anesthesia (CILA) decreases post-operative pain after radical cystectomy (RC).

II. To determine if CILA reduces narcotic requirements after RC.

SECONDARY OBJECTIVES:

I. To determine if CILA decreases length-of-stay after RC. II. To determine if CILA improves patients satisfaction with post-operative pain control after RC.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive ropivacaine hydrochloride intravenously (IV) continuously over 72 hours after radical cystectomy.

ARM II: Patients receive normal saline (placebo) IV continuously over 72 hours after radical cystectomy.

After completion of study, patients are followed up within 30 days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Bladder Carcinoma
  • Post-operative Pain
Intervention  ICMJE
  • Other: Placebo
    Given IV
    Other Names:
    • placebo therapy
    • PLCB
    • sham therapy
  • Other: Questionnaire Administration
    Ancillary studies
  • Drug: Ropivacaine Hydrochloride
    Given IV
    Other Names:
    • Naropin
    • Ropivacaine Hydrochloride Monohydrate
Study Arms  ICMJE
  • Experimental: Arm I (ropivacaine hydrochloride)
    Patients receive ropivacaine hydrochloride IV continuously over 72 hours after radical cystectomy.
    Interventions:
    • Other: Questionnaire Administration
    • Drug: Ropivacaine Hydrochloride
  • Placebo Comparator: Arm II (placebo)
    Patients receive normal saline (placebo) IV continuously over 72 hours after radical cystectomy.
    Interventions:
    • Other: Placebo
    • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 13, 2019)		 0
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2015)		 90
Estimated Study Completion Date  ICMJE February 25, 2022
Estimated Primary Completion Date February 25, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Undergoing elective open radical cystectomy
  • Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  • Allergy or adverse reaction to ropivacaine (ropivacaine hydrochloride) or any amide type of local anesthesia
  • Allergy or adverse reaction to local anesthesia catheter
  • Additional surgery at the same time as RC (e.g. nephroureterectomy)
  • Coagulopathy
  • Thrombocytopenia
  • Local or systemic infection
  • Pregnancy
  • Chronic hepatic disease
  • Use of type III antiarrhythmics (e.g. amiodarone)
  • History of chronic pain and/or daily opioid use
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02438852
Other Study ID Numbers  ICMJE 4B-14-4
NCI-2015-00279 ( Other Identifier: CTRP (Clinical Trial Reporting Program) )
4B-14-4 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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.: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Southern California
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Southern California
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Siamak Daneshmand University of Southern California
PRS Account University of Southern California
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP