A Phase 3 interventional study of Placebo and Questionnaire Administration in Bladder Carcinoma and Post-operative Pain, sponsored by University of Southern California. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by University of Southern California · Phase 3, Interventional, and Supportive care
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.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
Browse Urinary Bladder Neoplasms studies →University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive ropivacaine hydrochloride IV continuously over 72 hours after radical cystectomy.
Other: Questionnaire Administration · Drug: Ropivacaine Hydrochloride
Patients receive normal saline (placebo) IV continuously over 72 hours after radical cystectomy.
Other: Placebo · Other: Questionnaire Administration
Given IV
Also known as: placebo therapy, PLCB, sham therapy
Ancillary studies
Given IV
Also known as: Naropin, Ropivacaine Hydrochloride Monohydrate
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.
Time frame: Up to 72 hours after surgery
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.
Time frame: Up to 30 days after surgery
This study is withdrawn, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Southern California