NCT02438852

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Carcinoma
• Post-operative Pain

Interventions

Type	Name	Description
OTHER	Placebo	Given IV
OTHER	Questionnaire Administration	Ancillary studies
DRUG	Ropivacaine Hydrochloride	Given IV

Timeline

• Start date: 2019-02-25
• Primary completion: 2021-02-25
• Completion: 2022-02-25
• First posted: 2015-05-08
• Last updated: 2019-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study