Continuous Infusion of Ropivacaine Hydrochloride in Reducing Pain After Surgery in Patients With Bladder Cancer

Phase 3

Withdrawn

• Conditions: Bladder Carcinoma; Post-operative Pain
• Interventions: Other: Placebo; Drug: Ropivacaine Hydrochloride; Other: Questionnaire Administration

• Registration Number: NCT02438852
• Lead Sponsor: University of Southern California

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.

Study Timeline

• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-08
• Study Start: 2019-02-25
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-13
• Last Update Posted: 2019-04-16
• Primary Completion: 2021-02-25
• Study Completion: 2022-02-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (ropivacaine hydrochloride)	Ropivacaine Hydrochloride	Patients receive ropivacaine hydrochloride IV continuously over 72 hours after radical cystectomy.
Arm II (placebo)	Placebo	Patients receive normal saline (placebo) IV continuously over 72 hours after radical cystectomy.
Arm II (placebo)	Questionnaire Administration	Patients receive normal saline (placebo) IV continuously over 72 hours after radical cystectomy.
Arm I (ropivacaine hydrochloride)	Questionnaire Administration	Patients receive ropivacaine hydrochloride IV continuously over 72 hours after radical cystectomy.

Primary Outcome Measures

Name	Time	Method
Narcotic requirement	Up to 72 hours after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Length of hospitalization	Up to 30 days after surgery	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.

Trial Locations

Locations (1)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States