Study Stopped
No funding
Continuous Infusion of Ropivacaine Hydrochloride in Reducing Pain After Surgery in Patients With Bladder Cancer
Efficacy of Continuous Infusion of Local Anesthesia After Radical Cystectomy: A Randomized, Double Blind, Placebo Controlled Study
3 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2019
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2015
CompletedFirst Posted
Study publicly available on registry
May 8, 2015
CompletedStudy Start
First participant enrolled
February 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2022
CompletedApril 16, 2019
April 1, 2019
2 years
May 6, 2015
April 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Length of hospitalization
Up to 30 days after surgery
Study Arms (2)
Arm I (ropivacaine hydrochloride)
EXPERIMENTALPatients receive ropivacaine hydrochloride IV continuously over 72 hours after radical cystectomy.
Arm II (placebo)
PLACEBO COMPARATORPatients receive normal saline (placebo) IV continuously over 72 hours after radical cystectomy.
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- Undergoing elective open radical cystectomy
- Ability to understand and the willingness to sign a written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Californialead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Siamak Daneshmand
University of Southern California
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2015
First Posted
May 8, 2015
Study Start
February 25, 2019
Primary Completion
February 25, 2021
Study Completion
February 25, 2022
Last Updated
April 16, 2019
Record last verified: 2019-04