Postoperative PaincpnbNCT00653133
Multicenter Continuous Peripheral Nerve Block Surveillance Study
A study testing Ultrasound imaging and Peripheral nerve stimulator in people with Postoperative Pain, run by Halyard Health at 16 sites in United States.
Trial summary
This two tiered study is a multi-center, open label, surveillance study of the use of continuous nerve blocks with the ON-Q® C-bloc and either nerve stimulator or ultrasound guided continuous nerve block techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ultrasound imaging and Peripheral nerve stimulator
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,821 participants
- Where
- 16 sitesUnited States
- Study dates
- May 2007to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients having elective orthopedic surgery who are candidates for CPNB as part of their management program for postoperative pain
- Age >18
- Able to give consent
Who cannot join
- Morbid obesity (BMI> 40)
- Uncooperative or having psychological or linguistic difficulties
- Previous damage to the nerve or plexus
- Significant comorbidities which the primary investigator feels would limit the quality and collection of data
- Allergy to local anesthetic agents including ropivacaine, bupivacaine and lidocaine
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Kennestone Hospital
Atlanta, Georgia, 30060
The Medical Center of Bowling Green
Bowling Green, Kentucky, 42101
Arizona Joint and Spine
Chandler, Arizona, 85224
Roper Hospital
Charleston, South Carolina, 29403
Charlotte Medical Center
Charlotte, North Carolina, 28203
Miami Valley Hospital
Dayton, Ohio, 45459
Wesley Medical Center
Hattiesburg, Mississippi, 39402
Memorial Herman Hospital
Houston, Texas, 77030
Avista Adventist Hospital
Louisville, Colorado, 80027
Titus Regional Medical Center
Mount Pleasant, Texas, 75455
St. Vincents Catholic Medical Center
New York, New York, 10011
Bailey Medical Center
Owasso, Oklahoma, 74055
Virginia Commonwealth University
Richmond, Virginia, 25298
Santa Clara Valley Medical Center
San Jose, California, 4088855230
DesPeres Hospital
St Louis, Missouri, 63131
Caritas Good Samaritan
Stoughton, Massachusetts, 02072
About this study
Official title: Multicenter Continuous Peripheral Nerve Block Surveillance Study Comparing Ultrasound Guided Catheter Placement to Non Ultrasound Guided Catheter Placement Techniques
This two tiered study is a multi-center, open label, surveillance study of the use of continuous nerve blocks with the ON-Q® C-bloc and either nerve stimulator or ultrasound guided continuous nerve block techniques. This study was developed to investigate specific aspects of complication rates related to continuous nerve block techniques in patients undergoing orthopedic surgical procedures.
Read the detailed description
Continuous peripheral nerve block techniques require the placement of catheters near target peripheral nerves. The placement of these catheters is guided by either ultrasound visualization, nerve stimulation or a combination of the two.
This surveillance study was designed to look at the rates of catheter placement related complications with the two techniques.
- Conditions
- Postoperative Pain
- Being tested
- Ultrasound imaging, Peripheral nerve stimulator
- Keywords
- ultrasonography, peripheral nerve block, peripheral nerve stimulation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound imagingDevice
Ultrasound guided techniques for placement of peripheral nerve block catheters for continuous infusion of local anesthetic
Peripheral nerve stimulatorDevice
either stimulating needle or stimulating catheter used for placement of catheter for continuous infusion of local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| USPNB | Active comparator | Ultrasound imaging guided peripheral nerve block Receives: Device: Ultrasound imaging |
| NSPNB | Active comparator | Peripheral nerve stimulator guided peripheral nerve block catheter placement for continuous infusion of local anesthetic Receives: Device: Peripheral nerve stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications of Peripheral Nerve Block
Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic
Measured: Preoperative through 3 days post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startMay 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,821 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halyard Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joe Rodrigo, MD, Principal investigator, Roper Hospital, Charleston, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653133
- Sponsor's protocol ID
- iflocpnb2007
- Acronym
- cpnb
- Status last verified
- Dec 2014
- First submitted
- 28 Mar 2008
- Last updated
- 2 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Continuous Peripheral Nerve Block Surveillance Study Comparing Ultrasound Guided Catheter Placement to Non Ultrasound Guided Catheter Placement Techniques
- ClinicalTrials.gov ID
- NCT00653133
- Acronym / sponsor ID
- cpnb / iflocpnb2007
- Conditions
- Postoperative Pain
- Keywords
- ultrasonography, peripheral nerve block, peripheral nerve stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,821 participants (actual)
- Lead sponsor
- Halyard HealthIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 4 Apr 2008 (estimated)
- Results
- Posted 19 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This two tiered study is a multi-center, open label, surveillance study of the use of continuous nerve blocks with the ON-Q® C-bloc and either nerve stimulator or ultrasound guided continuous nerve block techniques. This study was developed to investigate specific aspects of complication rates related to continuous nerve block techniques in patients undergoing orthopedic surgical procedures.
Detailed description
Continuous peripheral nerve block techniques require the placement of catheters near target peripheral nerves. The placement of these catheters is guided by either ultrasound visualization, nerve stimulation or a combination of the two.
This surveillance study was designed to look at the rates of catheter placement related complications with the two techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| USPNB | Active comparator | Device: Ultrasound imagingUltrasound imaging guided peripheral nerve block |
| NSPNB | Active comparator | Device: Peripheral nerve stimulatorPeripheral nerve stimulator guided peripheral nerve block catheter placement for continuous infusion of local anesthetic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients having elective orthopedic surgery who are candidates for CPNB as part of their management program for postoperative pain
- Age >18
- Able to give consent
Key exclusion criteria (5 listed)
- Morbid obesity (BMI> 40)
- Uncooperative or having psychological or linguistic difficulties
- Previous damage to the nerve or plexus
- Significant comorbidities which the primary investigator feels would limit the quality and collection of data
- Allergy to local anesthetic agents including ropivacaine, bupivacaine and lidocaine
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 |
|---|---|---|
| Ultrasound imagingUltrasound guided techniques for placement of peripheral nerve block catheters for continuous infusion of local anesthetic | Device | USPNB |
| Peripheral nerve stimulatoreither stimulating needle or stimulating catheter used for placement of catheter for continuous infusion of local anesthetic | Device | NSPNB |
Primary outcome
Complications of Peripheral Nerve Block
Time frame: Preoperative through 3 days post operative
Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joe Rodrigo, MD principal investigator
Roper Hospital, Charleston, SC
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound imaging and Peripheral nerve stimulator in people with Postoperative Pain, run by Halyard Health at 16 sites 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 3 inclusion and 5 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 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Complications of Peripheral Nerve Block (time frame: Preoperative through 3 days post operative). 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 2 Oct 2018.