Bladder CarcinomaPhase 3NCT02438852
Continuous Infusion of Ropivacaine Hydrochloride in Reducing Pain After Surgery in Patients With Bladder Cancer
A Phase 3 study testing Questionnaire Administration and Ropivacaine Hydrochloride in people with Bladder Carcinoma and Post-operative Pain, run by University of Southern California at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Carcinoma, Post-operative Pain
- What is being tested?
- Questionnaire Administration and Ropivacaine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2019to 25 Feb 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing elective open radical cystectomy
- Ability to understand and the willingness to sign a written informed consent
Who cannot join
- 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
Show all 10Show fewer
- Pregnancy
- Chronic hepatic disease
- Use of type III antiarrhythmics (e.g. amiodarone)
- History of chronic pain and/or daily opioid use
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Bladder Carcinoma, Post-operative Pain
- Being tested
- Placebo, Questionnaire Administration, Ropivacaine Hydrochloride
- Medical subject headings
- Urinary Bladder Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given IV
Questionnaire AdministrationOther
Ancillary studies
Ropivacaine HydrochlorideDrug
Also called Naropin, Ropivacaine Hydrochloride Monohydrate
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (ropivacaine hydrochloride) | Experimental | Patients receive ropivacaine hydrochloride IV continuously over 72 hours after radical cystectomy. Receives: Other: Questionnaire Administration; Drug: Ropivacaine Hydrochloride |
| Arm II (placebo) | Placebo comparator | Patients receive normal saline (placebo) IV continuously over 72 hours after radical cystectomy. Receives: Other: Placebo; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 72 hours after surgery
Secondary outcomes (1)
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.
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study start25 Feb 2019 (estimated)
- Primary completion25 Feb 2021 (estimated)
- Study completion25 Feb 2022 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Siamak Daneshmand, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438852
- Sponsor's protocol ID
- 4B-14-4
- Other IDs
- NCI-2015-00279, 4B-14-4, P30CA014089
- Status last verified
- Apr 2019
- First submitted
- 6 May 2015
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Continuous Infusion of Local Anesthesia After Radical Cystectomy: A Randomized, Double Blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT02438852
- Acronym / sponsor ID
- 4B-14-4
- Conditions
- Bladder Carcinoma, Post-operative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Feb 2019 (estimated)
- Primary completion
- 25 Feb 2021 (estimated)
- Study completion
- 25 Feb 2022 (estimated)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (ropivacaine hydrochloride) | Experimental | Other: Questionnaire Administration, Drug: Ropivacaine HydrochloridePatients receive ropivacaine hydrochloride IV continuously over 72 hours after radical cystectomy. |
| Arm II (placebo) | Placebo comparator | Other: Placebo, Other: Questionnaire AdministrationPatients receive normal saline (placebo) IV continuously over 72 hours after radical cystectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing elective open radical cystectomy
- Ability to understand and the willingness to sign a written informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven IV | Other | Arm II (placebo) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (ropivacaine hydrochloride), Arm II (placebo) |
| Ropivacaine HydrochlorideAlso: Naropin, Ropivacaine Hydrochloride MonohydrateGiven IV | Drug | Arm I (ropivacaine hydrochloride) |
Primary outcome
Narcotic requirement
Time frame: 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.
1 secondary outcome
Length of hospitalization
Time frame: Up to 30 days after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
Related trials for Bladder Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siamak Daneshmand principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Questionnaire Administration and Ropivacaine Hydrochloride in people with Bladder Carcinoma and Post-operative Pain, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Narcotic requirement (time frame: Up to 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.