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

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.

Study Overview

• Status: Withdrawn
• Conditions: Bladder Carcinoma; Post-operative Pain
• Intervention / Treatment: Other: Questionnaire Administration; Drug: Ropivacaine Hydrochloride; Other: Placebo

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.

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC / Norris Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Undergoing elective open radical cystectomy
• Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (ropivacaine hydrochloride); Patients receive ropivacaine hydrochloride IV continuously over 72 hours after radical cystectomy.	Other: Questionnaire Administration; Ancillary studies; Drug: Ropivacaine Hydrochloride; Given IV; Other Names: Naropin; Ropivacaine Hydrochloride Monohydrate
Placebo Comparator: Arm II (placebo); Patients receive normal saline (placebo) IV continuously over 72 hours after radical cystectomy.	Other: Questionnaire Administration; Ancillary studies; Other: Placebo; Given IV; Other Names: placebo therapy; PLCB; sham therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Siamak Daneshmand, University of Southern California

Study record dates

Study Major Dates

• Study Start (Anticipated): February 25, 2019
• Primary Completion (Anticipated): February 25, 2021
• Study Completion (Anticipated): February 25, 2022

Study Registration Dates

• First Submitted: May 6, 2015
• First Submitted That Met QC Criteria: May 7, 2015
• First Posted (Estimate): May 8, 2015

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 13, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Urinary Bladder Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 4B-14-4 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2015-00279 (Other Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes