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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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No funding
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (ropivacaine hydrochloride) | Experimental | Patients receive ropivacaine hydrochloride IV continuously over 72 hours after radical cystectomy. |
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| Arm II (placebo) | Placebo Comparator | Patients receive normal saline (placebo) IV continuously over 72 hours after radical cystectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Given IV |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siamak Daneshmand | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
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| Questionnaire Administration | Other | Ancillary studies |
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| Ropivacaine Hydrochloride | Drug | Given IV |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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