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

University of Southern California

Status and phase: Withdrawn; Phase 3

Conditions: Post-operative Pain; Bladder Carcinoma

Treatments: Other: Questionnaire Administration; Drug: Ropivacaine Hydrochloride; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02438852

NCI-2015-00279 (Other Identifier)

4B-14-4 (Other Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Arm I (ropivacaine hydrochloride)

Experimental group

Description:

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

Treatment:

Other: Questionnaire Administration

Drug: Ropivacaine Hydrochloride

Arm II (placebo)

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Other: Questionnaire Administration