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

Information source: University of Southern California
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bladder Carcinoma; Post-operative Pain

Intervention: Placebo (Other); Questionnaire Administration (Other); Ropivacaine Hydrochloride (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: University of Southern California

Official(s) and/or principal investigator(s):
Siamak Daneshmand, Principal Investigator, Affiliation: University of Southern California

Overall contact:
Ileana Aldana, Phone: 323-865-0702, Email: Ileana.aldana@med.usc.edu

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome:

Narcotic requirement

Visual Analog Scale (VAS) pain scores (0-10)

Secondary outcome:

Length of hospitalization

Patient satisfaction with postoperative pain control

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Ileana Aldana, Phone: 323-865-0702, Email: Ileana.aldana@med.usc.edu

USC / Norris Comprehensive Cancer Center, Los Angeles, California 90033, United States; Not yet recruiting
Ileana Aldana, Phone: 323-865-3700, Email: Ileana.aldana@med.usc.edu
Siamak Daneshmand, Principal Investigator
Additional Information

Starting date: June 2015
Last updated: May 7, 2015

Page last updated: August 23, 2015

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