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

Primary Purpose

Bladder Carcinoma, Post-operative Pain

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placebo
Questionnaire Administration
Ropivacaine Hydrochloride
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bladder Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC / Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I (ropivacaine hydrochloride)

Arm II (placebo)

Arm Description

Patients receive ropivacaine hydrochloride IV continuously over 72 hours after radical cystectomy.

Patients receive normal saline (placebo) IV continuously over 72 hours after radical cystectomy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 6, 2015
Last Updated
April 13, 2019
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02438852
Brief Title
Continuous Infusion of Ropivacaine Hydrochloride in Reducing Pain After Surgery in Patients With Bladder Cancer
Official Title
Efficacy of Continuous Infusion of Local Anesthesia After Radical Cystectomy: A Randomized, Double Blind, Placebo Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
February 25, 2019 (Anticipated)
Primary Completion Date
February 25, 2021 (Anticipated)
Study Completion Date
February 25, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Carcinoma, Post-operative Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (ropivacaine hydrochloride)
Arm Type
Experimental
Arm Description
Patients receive ropivacaine hydrochloride IV continuously over 72 hours after radical cystectomy.
Arm Title
Arm II (placebo)
Arm Type
Placebo Comparator
Arm Description
Patients receive normal saline (placebo) IV continuously over 72 hours after radical cystectomy.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo therapy, PLCB, sham therapy
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Drug
Intervention Name(s)
Ropivacaine Hydrochloride
Other Intervention Name(s)
Naropin, Ropivacaine Hydrochloride Monohydrate
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Narcotic requirement
Description
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
Secondary Outcome Measure Information:
Title
Length of hospitalization
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siamak Daneshmand
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

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

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