Ignite Creation Date:
2024-05-06 @ 4:02 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02438852
Status:
WITHDRAWN
Last Update Posted:
2019-04-16
First Post:
2015-05-06
Brief Title:
Continuous Infusion of Ropivacaine Hydrochloride in Reducing Pain After Surgery in Patients With Bladder Cancer
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Efficacy of Continuous Infusion of Local Anesthesia After Radical Cystectomy A Randomized Double Blind Placebo Controlled Study
Status:
WITHDRAWN
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2015-00279 | OTHER | None | None |
| 4B-14-4 | OTHER | None | None |
| P30CA014089 | NIH | USC Norris Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA014089 |