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Recruitment Status : Withdrawn (No funding)
First Posted : May 8, 2015
Last Update Posted : April 16, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Bladder Carcinoma Post-operative Pain||Other: Placebo Other: Questionnaire Administration Drug: Ropivacaine Hydrochloride||Phase 3|
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.
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)|
|Actual Enrollment :||0 participants|
|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|
Experimental: Arm I (ropivacaine hydrochloride)
Patients receive ropivacaine hydrochloride IV continuously over 72 hours after radical cystectomy.
Other: Questionnaire Administration
Drug: Ropivacaine Hydrochloride
Placebo Comparator: Arm II (placebo)
Patients receive normal saline (placebo) IV continuously over 72 hours after radical cystectomy.
Other: Questionnaire Administration
- 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.
- 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|
- Undergoing elective open radical cystectomy
- Ability to understand and the willingness to sign a written informed consent
- 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)
- Local or systemic infection
- Chronic hepatic disease
- Use of type III antiarrhythmics (e.g. amiodarone)
- History of chronic pain and/or daily opioid use
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
|United States, California|
|USC / Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Siamak Daneshmand||University of Southern California|
|Responsible Party:||University of Southern California|
|Other Study ID Numbers:||
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:||April 16, 2019|
|Last Verified:||April 2019|
|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|
Urinary Bladder Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents