Knee Arthritis DiseasePhase 4NCT01978275
Stimulating Catheter for Lumbar Plexus
A Phase 4 study testing stimulong 100, pajunk, germany and plexolong 100, pajunk, germany in people with Knee Arthritis Disease, run by ASST Gaetano Pini-CTO at 1 site in Italy.
Trial summary
Stimulating catheters have been introduced to reduce the incidence of secondary failure after continuous peripheral nerve blocks, but they effectiveness over traditional nonstimulating catheters is still controversial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthritis Disease
- What is being tested?
- stimulong 100, pajunk, germany and plexolong 100, pajunk, germany
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2013to Dec 2013
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing total knee arthroplasty
Who cannot join
- diabetes
- coagulation disorders
- allergy to local anesthetic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Are Stimulating Catheters More Efficacy for Lumbar Plexus Block Compared With Traditional Non-stimulating Ones? A Randomized, Prospective, Blinded, up and Down Study.
Stimulating catheters have been introduced to reduce the incidence of secondary failure after continuous peripheral nerve blocks, but they effectiveness over traditional nonstimulating catheters is still controversial. Furthermore no volume-response study has compared the success rates of the two techniques for continuous lumbar plexus block. The aim of this prospective, randomized, blinded study is to detect if stimulating catheters decrease the minimal effective volume (MEAV) of 1.5% mepivacaine required for successful lumbar plexus block (LPB) in 50% of patients compared with conventional non-stimulating catheters.
- Conditions
- Knee Arthritis Disease
- Being tested
- stimulong 100, pajunk, germany, plexolong 100, pajunk, germany
- Keywords
- total knee arthroplasty, lumbar plexus block, stimulating catheters, peripheral nerve blocks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stimulong 100, pajunk, germanyDevice
simulating catheter
plexolong 100, pajunk, germanyDevice
nonstimulating catheter
| Study group | Role | What they receive |
|---|---|---|
| stimulating catheters group | Experimental | Lumbar plexus block performed through stimulating catheter Receives: Device: stimulong 100, pajunk, germany |
| nonstimulating catheters | Active comparator | lumbar plexus block through nonstimulating catheters Receives: Device: plexolong 100, pajunk, germany |
What is being measured
The primary outcome is the main question the study is designed to answer.
minimum effective anesthetic volume in 50% of patients
Measured: thirty minutes after local anesthetic injection
Secondary outcomes (1)
morphine requirement
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthritis DiseaseStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASST Gaetano Pini-CTO
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Cappelleri, ASST Gaetano Pini-CTO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978275
- Sponsor's protocol ID
- IOGPGC02-13
- Status last verified
- Dec 2013
- First submitted
- 25 Oct 2013
- Last updated
- 17 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Stimulating Catheters More Efficacy for Lumbar Plexus Block Compared With Traditional Non-stimulating Ones? A Randomized, Prospective, Blinded, up and Down Study.
- ClinicalTrials.gov ID
- NCT01978275
- Acronym / sponsor ID
- IOGPGC02-13
- Conditions
- Knee Arthritis Disease
- Keywords
- total knee arthroplasty, lumbar plexus block, stimulating catheters, peripheral nerve blocks
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- ASST Gaetano Pini-CTOUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Nov 2013 (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.
Stimulating catheters have been introduced to reduce the incidence of secondary failure after continuous peripheral nerve blocks, but they effectiveness over traditional nonstimulating catheters is still controversial. Furthermore no volume-response study has compared the success rates of the two techniques for continuous lumbar plexus block. The aim of this prospective, randomized, blinded study is to detect if stimulating catheters decrease the minimal effective volume (MEAV) of 1.5% mepivacaine required for successful lumbar plexus block (LPB) in 50% of patients compared with conventional non-stimulating catheters.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stimulating catheters group | Experimental | Device: stimulong 100, pajunk, germanyLumbar plexus block performed through stimulating catheter |
| nonstimulating catheters | Active comparator | Device: plexolong 100, pajunk, germanylumbar plexus block through nonstimulating catheters |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing total knee arthroplasty
Key exclusion criteria (3 listed)
- diabetes
- coagulation disorders
- allergy to local anesthetic
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 |
|---|---|---|
| stimulong 100, pajunk, germanysimulating catheter | Device | stimulating catheters group |
| plexolong 100, pajunk, germanynonstimulating catheter | Device | nonstimulating catheters |
Primary outcome
minimum effective anesthetic volume in 50% of patients
Time frame: thirty minutes after local anesthetic injection
1 secondary outcome
morphine requirement
Time frame: intraoperatively
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 17 Feb 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 stimulong 100, pajunk, germany and plexolong 100, pajunk, germany in people with Knee Arthritis Disease, run by ASST Gaetano Pini-CTO at 1 site in Italy.
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 1 inclusion and 3 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 17 Feb 2014. 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 Italy. 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?
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?
minimum effective anesthetic volume in 50% of patients (time frame: thirty minutes after local anesthetic injection). 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 17 Feb 2014; AzTrials last refreshed its copy on 27 Oct 2026.