Paravertebral Catheter InsertionPhase 4NCT01231204
Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks
A Phase 4 study testing Ropivicaine 0.4% Continuous Infusion in people with Paravertebral Catheter Insertion and Mastectomy, run by University of California, San Diego at 1 site in United States.
Trial summary
Research study to determine if putting local anesthetic-or numbing medication-through a tiny tube placed next to the nerves that go to a breast prior to and following a mastectomy will decrease subsequent pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Paravertebral Catheter Insertion, Mastectomy, Breast Cancer
- What is being tested?
- Ropivicaine 0.4% Continuous Infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Mar 2016
- Phase
- Phase 4
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing unilateral or bilateral mastectomy
- desiring analgesia with a paravertebral nerve block(s)
- age 18 years or older
- female
Who cannot join
- morbid obesity as defined by a body mass index > 40
- renal insufficiency
- chronic opioid use
- history of opioid abuse
- any comorbidity which results in moderate or severe functional limitation
- inability to communicate with the investigators or hospital staff
- pregnancy
- incarceration
Trial locations and contacts
1 site in 1 country.
About this study
Research study to determine if putting local anesthetic-or numbing medication-through a tiny tube placed next to the nerves that go to a breast prior to and following a mastectomy will decrease subsequent pain.
Read the detailed description
Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of a multiple-day ambulatory continuous paravertebral block decreases the incidence and severity of post-mastectomy pain.
Hypothesis 1: Following mastectomy, the incidence and severity of breast pain will be significantly decreased in the week following surgery with a multiple-day ambulatory continuous paravertebral block as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).
Hypothesis 2: Following mastectomy, the incidence and severity of chronic pain will be significantly decreased three months following multiple-day ambulatory continuous paravertebral blocks as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).
- Conditions
- Paravertebral Catheter Insertion, Mastectomy, Breast Cancer
- Being tested
- Placebo (normal saline) Continuous Infusion, Ropivicaine 0.4% Continuous Infusion
- Keywords
- Breast Cancer, Mastectomy, UCSD, Surgery, PVB Catheter, Paravertebral Catheter, Breast Pain, Mastectomy Pain, Postoperative Pain
- Medical subject headings
- Breast Neoplasms, Mastodynia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (normal saline) Continuous InfusionProcedure or surgery
Patients randomized to this group will receive an initial catheter placement using the standard Ultrasound-guided Technique. For the surgical procedure they will receive 15cc of 0.5%Ropivicaine. Following the surgical procedure they will receive a pain pump filled with normal saline. The normal saline infusion will continue for the 3 days following surgery. All patients will have access to other pain relievers for break-through pain. All patients will have the outcome measures assessed.
Ropivicaine 0.4% Continuous InfusionProcedure or surgery
Patients randomized to this group will receive an initial catheter placement using the standard Ultrasound-guided Technique. For the surgical procedure they will receive 15cc of 0.5%Ropivicaine. Following the surgical procedure they will receive a pain pump filled with 0.4%Ropivicaine. The 0.4%Ropivicaine infusion will continue for the 3 days following surgery. All patients will have access to other pain relievers for break-through pain. All patients will have the outcome measures assessed.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Infusion | Placebo comparator | Patients will be randomized to receive a continuous infusion of Normal Saline via a Paravertebral Nerve Block. Receives: Procedure: Placebo (normal saline) Continuous Infusion |
| Ropivicaine 0.4% Infusion | Active comparator | Patients will be randomized to receive a continuous infusion of 0.4% Ropivicaine via a Paravertebral Nerve Block. Receives: Procedure: Ropivicaine 0.4% Continuous Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores (NRS)
Pain score on the 0-10 Numeric Rating Scale given as part of the Brief Pain Inventory
Measured: Day following Surgery
Secondary outcomes (6)
Pain scores
Measured on the NRS (defined above) during the first 4 postoperative days
Measured: First 4 postoperative days
Opioid Requirements
Both in and out of the hospital during the first 3 postoperative days
Measured: First 4 postoperative days
Opioid-related side effects
Both in and out of the hospital during the first 4 postoperative days
Measured: First 4 postoperative days
Sleep Disturbances
Due to breast pain during the first 4 postoperative days
Measured: First 4 postoperative days
Cancer Recurrence
Patients' records will be investigated for indications of cancer recurrence up to 3 years following catheter placement (including estrogen receptor status as + or -). Patients may be contacted by phone if records suggest that the patient has not returned to the original surgeon within the previous 12 months
Measured: One Year following Surgery
Pain and Physical Functioning
Brief Pain Inventory given by phone on postop day 1, 4, 8; and weeks 4, 12; and months 3 and 12
Measured: Within first year of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2012
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paravertebral Catheter InsertionStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian M. Ilfeld, MD, MS, University of California, San Diego
- Investigators
- Brian M Ilfeld, M.D., M.S., Principal investigator, University of California, San Diego, Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231204
- Sponsor's protocol ID
- PVB Catheter Study
- Status last verified
- Apr 2016
- First submitted
- 27 Oct 2010
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks
- ClinicalTrials.gov ID
- NCT01231204
- Acronym / sponsor ID
- PVB Catheter Study
- Conditions
- Paravertebral Catheter Insertion, Mastectomy, Breast Cancer
- Keywords
- Breast Cancer, Mastectomy, UCSD, Surgery, PVB Catheter, Paravertebral Catheter, Breast Pain, Mastectomy Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Nov 2010 (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.
Research study to determine if putting local anesthetic-or numbing medication-through a tiny tube placed next to the nerves that go to a breast prior to and following a mastectomy will decrease subsequent pain.
Detailed description
Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of a multiple-day ambulatory continuous paravertebral block decreases the incidence and severity of post-mastectomy pain.
Hypothesis 1: Following mastectomy, the incidence and severity of breast pain will be significantly decreased in the week following surgery with a multiple-day ambulatory continuous paravertebral block as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).
Hypothesis 2: Following mastectomy, the incidence and severity of chronic pain will be significantly decreased three months following multiple-day ambulatory continuous paravertebral blocks as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Infusion | Placebo comparator | Procedure: Placebo (normal saline) Continuous InfusionPatients will be randomized to receive a continuous infusion of Normal Saline via a Paravertebral Nerve Block. |
| Ropivicaine 0.4% Infusion | Active comparator | Procedure: Ropivicaine 0.4% Continuous InfusionPatients will be randomized to receive a continuous infusion of 0.4% Ropivicaine via a Paravertebral Nerve Block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- undergoing unilateral or bilateral mastectomy
- desiring analgesia with a paravertebral nerve block(s)
- age 18 years or older
- female
Key exclusion criteria (8 listed)
- morbid obesity as defined by a body mass index > 40
- renal insufficiency
- chronic opioid use
- history of opioid abuse
- any comorbidity which results in moderate or severe functional limitation
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 |
|---|---|---|
| Placebo (normal saline) Continuous InfusionPatients randomized to this group will receive an initial catheter placement using the standard Ultrasound-guided Technique. For the surgical procedure they will receive 15cc of 0.5%Ropivicaine. Following the surgical procedure they will receive a pain pump filled with normal saline. The normal saline infusion will continue for the 3 days following surgery. All patients will have access to other pain relievers for break-through pain. All patients will have the outcome measures assessed. | Procedure or surgery | Placebo Infusion |
| Ropivicaine 0.4% Continuous InfusionPatients randomized to this group will receive an initial catheter placement using the standard Ultrasound-guided Technique. For the surgical procedure they will receive 15cc of 0.5%Ropivicaine. Following the surgical procedure they will receive a pain pump filled with 0.4%Ropivicaine. The 0.4%Ropivicaine infusion will continue for the 3 days following surgery. All patients will have access to other pain relievers for break-through pain. All patients will have the outcome measures assessed. | Procedure or surgery | Ropivicaine 0.4% Infusion |
Primary outcome
Pain Scores (NRS)
Time frame: Day following Surgery
Pain score on the 0-10 Numeric Rating Scale given as part of the Brief Pain Inventory
6 secondary outcomes
Pain scores
Time frame: First 4 postoperative days
Opioid Requirements
Time frame: First 4 postoperative days
Opioid-related side effects
Time frame: First 4 postoperative days
Sleep Disturbances
Time frame: First 4 postoperative days
Cancer Recurrence
Time frame: One Year following Surgery
Pain and Physical Functioning
Time frame: Within first year of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
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.
Brian M Ilfeld, M.D., M.S. principal investigator
University of California, San Diego, Department of Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivicaine 0.4% Continuous Infusion in people with Paravertebral Catheter Insertion and Mastectomy, run by University of California, San Diego 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 11 Apr 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain Scores (NRS) (time frame: Day following 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 11 Apr 2016.