Continuous Infusion of Ropivacaine Hydrochloride in Reducing Pain After Surgery in Patients With Bladder Cancer
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Post-Surgical Pain, Hospital |
| Therapuetic Areas: | Musculoskeletal, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/13/2018 |
| Start Date: | February 25, 2019 |
| End Date: | February 25, 2022 |
| Contact: | Ileana Aldana |
| Email: | Ileana.aldana@med.usc.edu |
| Phone: | 323-865-0702 |
Efficacy of Continuous Infusion of Local Anesthesia After Radical Cystectomy: A Randomized, Double Blind, Placebo Controlled Study
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.
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.
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.
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.
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
We found this trial at
1
site
1441 Eastlake Ave
Los Angeles, California 90033
Los Angeles, California 90033
(323) 865-3000
Principal Investigator: Siamak Daneshmand, MD
Phone: 323-865-3700
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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