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

Study Overview
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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.

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.

Official Title
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Efficacy of Continuous Infusion of Local Anesthesia After Radical Cystectomy: A Randomized, Double Blind, Placebo Controlled Study

Conditions
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Bladder Carcinoma, Post-operative Pain

Intervention / Treatment
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* Other: Placebo
* Other: Questionnaire Administration
* Drug: Ropivacaine Hydrochloride


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (ropivacaine hydrochloride)<br>Patients receive ropivacaine hydrochloride IV continuously over 72 hours after radical cystectomy. | Other: Questionnaire Administration<br>* Ancillary studies<br>Drug: Ropivacaine Hydrochloride<br>* Given IV<br>* Other names: Ropivacaine Hydrochloride Monohydrate;|
| Placebo Comparator: Arm II (placebo)<br>Patients receive normal saline (placebo) IV continuously over 72 hours after radical cystectomy. | Other: Placebo<br>* Given IV<br>* Other names: sham therapy;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotic requirement | 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. | Up to 72 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospitalization | 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. | Up to 30 days after surgery |