PainPhase 4NCT00980577
Stimulating Catheter With or Without Ultrasound Guidance
A Phase 4 study testing NUUS in people with Pain, run by Peking University Third Hospital at 1 site in China.
Trial summary
To study whether the combination of ultrasound guidance and stimulating catheter could reduce the time for needle and catheter insertion compared with using stimulating catheter alone. Secondary outcomes: analgesic effects after the surgery. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Pain
- What is being tested?
- NUUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Nov 2009
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective primary total knee replacement surgery under neuraxial anesthesia ASA<=4
- Able to give informed consent
- Able to cooperate with sensory and motor testing of lower limb function
Who cannot join
- coagulopathy
- Allergy to local anaesthetic or postanalgesic rescue regimen
- Signs, symptoms or laboratory evidence of local infection or systemic sepsis
- No pre-existing neurological deficit (sensory or motor) affecting lower limb
- Patients with lower limb amputations
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hosptial
Beijing, 100191
About this study
Official title: Phase 2 Study of Stimulating Catheter for Continuous Femoral Nerve Block in Total Knee Replacement
To study whether the combination of ultrasound guidance and stimulating catheter could reduce the time for needle and catheter insertion compared with using stimulating catheter alone. Secondary outcomes: analgesic effects after the surgery.
- Conditions
- Pain
- Being tested
- NUUS
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUUSDevice
Also called stimulating catheter will be inserted under stimulator and ungrasoud guidance
Sonosite Micro Maxx
| Study group | Role | What they receive |
|---|---|---|
| NS | Active comparator | stimulating catheter will be inserted using stimulator Receives: Device: NUUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
time and number of attempts to perform block, the efficacy of the block
Measured: during the block procedure
Secondary outcomes (1)
postoperative analgesic effect
Measured: pod 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startJan 2008
- Primary completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980577
- Sponsor's protocol ID
- PUTH7275
- Status last verified
- Sep 2009
- First submitted
- 18 Sep 2009
- Last updated
- 10 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Stimulating Catheter for Continuous Femoral Nerve Block in Total Knee Replacement
- ClinicalTrials.gov ID
- NCT00980577
- Acronym / sponsor ID
- PUTH7275
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Nov 2009 (estimated)
- First posted
- 21 Sep 2009 (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.
To study whether the combination of ultrasound guidance and stimulating catheter could reduce the time for needle and catheter insertion compared with using stimulating catheter alone. Secondary outcomes: analgesic effects after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NS | Active comparator | Device: NUUSstimulating catheter will be inserted using stimulator |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective primary total knee replacement surgery under neuraxial anesthesia ASA<=4
- Able to give informed consent
- Able to cooperate with sensory and motor testing of lower limb function
Key exclusion criteria (5 listed)
- coagulopathy
- Allergy to local anaesthetic or postanalgesic rescue regimen
- Signs, symptoms or laboratory evidence of local infection or systemic sepsis
- No pre-existing neurological deficit (sensory or motor) affecting lower limb
- Patients with lower limb amputations
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 |
|---|---|---|
| NUUSAlso: stimulating catheter will be inserted under stimulator and ungrasoud guidanceSonosite Micro Maxx | Device | NS |
Primary outcome
time and number of attempts to perform block, the efficacy of the block
Time frame: during the block procedure
1 secondary outcome
postoperative analgesic effect
Time frame: pod 1-3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2010.
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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.
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 NUUS in people with Pain, run by Peking University Third Hospital at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 10 Nov 2010. 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 China. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Li, MD (86-10-82266688 ext. 8799, liminanesth@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time and number of attempts to perform block, the efficacy of the block (time frame: during the block procedure). 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 10 Nov 2010.