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

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ClinicalTrials.gov Identifier: NCT02438852
Recruitment Status : Not yet recruiting
First Posted : May 8, 2015
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

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.

Condition or disease Intervention/treatment Phase
Bladder Carcinoma Post-operative Pain Other: Placebo Other: Questionnaire Administration Drug: Ropivacaine Hydrochloride Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Efficacy of Continuous Infusion of Local Anesthesia After Radical Cystectomy: A Randomized, Double Blind, Placebo Controlled Study
Estimated Study Start Date : February 25, 2019
Estimated Primary Completion Date : February 25, 2021
Estimated Study Completion Date : February 25, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Arm I (ropivacaine hydrochloride)
Patients receive ropivacaine hydrochloride IV continuously over 72 hours after radical cystectomy.
Other: Questionnaire Administration
Ancillary studies

Drug: Ropivacaine Hydrochloride
Given IV
Other Names:
  • Naropin
  • Ropivacaine Hydrochloride Monohydrate

Placebo Comparator: Arm II (placebo)
Patients receive normal saline (placebo) IV continuously over 72 hours after radical cystectomy.
Other: Placebo
Given IV
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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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 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

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): NCT02438852


Contacts
Contact: Ileana Aldana 323-865-0702 Ileana.aldana@med.usc.edu

Locations
United States, California
USC / Norris Comprehensive Cancer Center Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Ileana Aldana    323-865-3700    Ileana.aldana@med.usc.edu   
Principal Investigator: Siamak Daneshmand, MD         
Sub-Investigator: Brian Hu, MD         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
Principal Investigator: Siamak Daneshmand University of Southern California

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02438852     History of Changes
Other Study ID Numbers: 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 )
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

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

Additional relevant MeSH terms:
Pain, Postoperative
Urinary Bladder Neoplasms
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents