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

Post-operative Pain Clinical Trial

Official title:

Efficacy of Continuous Infusion of Local Anesthesia After Radical Cystectomy: A Randomized, Double Blind, Placebo Controlled Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02438852
• Other study ID #: 4B-14-4
• Secondary ID: NCI-2015-002794B
• Status: Withdrawn
• Phase: Phase 3
• Start date: February 25, 2019
• Est. completion date: February 25, 2022

Study information

• Verified date: April 2019
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 25, 2022
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Carcinoma
• Pain, Postoperative
• Post-operative Pain
• Urinary Bladder Neoplasms

Intervention

Other:
• Placebo
Given IV
• Questionnaire Administration
Ancillary studies

Drug:
• Ropivacaine Hydrochloride
Given IV

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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