Bladder Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Study ID:

NCT02438852

Recruitment Status:

Withdrawn

Sponsor:

University of Southern California

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There is 1 Location for this study

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USC / Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Study ID:

NCT02438852

Recruitment Status:

Withdrawn

Sponsor:


University of Southern California

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