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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-25

Study Completion Date

2022-02-25

Brief Summary

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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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Detailed Description

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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.

Conditions

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Bladder Carcinoma Post-operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Arm I (ropivacaine hydrochloride)

Patients receive ropivacaine hydrochloride IV continuously over 72 hours after radical cystectomy.

Group Type EXPERIMENTAL

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Ropivacaine Hydrochloride

Intervention Type DRUG

Given IV

Arm II (placebo)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Given IV

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Placebo

Given IV

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Ropivacaine Hydrochloride

Given IV

Intervention Type DRUG

Other Intervention Names

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placebo therapy PLCB sham therapy Naropin Ropivacaine Hydrochloride Monohydrate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No