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

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02438852

Enrollment

Registered

2015-05-08

Start date

2019-02-25

Completion date

2022-02-25

Last updated

2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Carcinoma, Post-operative Pain

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.

Interventions

OTHERPlacebo

Given IV

OTHERQuestionnaire Administration

Ancillary studies

DRUGRopivacaine Hydrochloride

Given IV

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026