Arthropathy of Knee JointNCT01198340
Evaluation of Optimal Dose of Local Anesthetics for Patient Controlled Continuous Femoral Nerve Block
A study testing PC-FNB with basal administration of local anesthetics and PC-FNB without basal local anesthetics in people with Arthropathy of Knee Joint, run by Okayama University at 1 site in Japan.
Trial summary
To evaluate an analgesic effect without basal administration of local anesthetics for patient-controlled femoral nerve block (with sciatic nerve block) after total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Arthropathy of Knee Joint
- What is being tested?
- PC-FNB with basal administration of local anesthetics and PC-FNB without basal local anesthetics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2010to Jun 2012
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients older than 20 yrs old scheduled for total knee arthroplasty
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Anesthesiology and Resuscitology, Okayama University Hospital
Okayama, Okayama-ken, 700-8558
Hideki Taninishi, MD, PhD, 81-86-235-7327, tanishi@ops.dti.ne.jp
Hideki Taninishi, MD, PhD
About this study
Official title: Evaluation of Optimal Dose of Local Anesthetics for Patient Controlled Continuous Femoral Nerve Block With Sciatic Nerve Block After Total Knee Arthroplasty
To evaluate an analgesic effect without basal administration of local anesthetics for patient-controlled femoral nerve block (with sciatic nerve block) after total knee arthroplasty.
- Conditions
- Arthropathy of Knee Joint
- Being tested
- PC-FNB with basal administration of local anesthetics, PC-FNB without basal local anesthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC-FNB with basal administration of local anestheticsProcedure or surgery
Also called PC-FNB with basal ropivacaine administration
Administration of 0.2% ropivacaine for femoral nerve block with 3 ml/h of basal dose, 5ml bolus by the patient, 60 minutes of lock out time.
PC-FNB without basal local anestheticsProcedure or surgery
Also called PC-FAB without basal ropivacaine administration
Administration of 0.2% ropivacaine for femoral nerve block without basal dose, with 8 ml bolus by the patient, 60 minutes of lockout time.
| Study group | Role | What they receive |
|---|---|---|
| With basal local anesthetics | Active comparator | Not described Receives: Procedure: PC-FNB with basal administration of local anesthetics |
| Without basal local anesthetics | Experimental | Not described Receives: Procedure: PC-FNB without basal local anesthetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores by use of numerous rating scale (NRS)
Measured: 4 days after the surgery
Secondary outcomes (1)
dose of local anesthetics
Measured: 4 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of Knee JointStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Okayama University
- Sponsor type
- University, hospital or other
- Investigators
- Hideki Taninishi, MD, PhD, Principal investigator, Okayama University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198340
- Sponsor's protocol ID
- TKAFEMORAL-2010
- Other IDs
- UMIN000004155
- Status last verified
- Aug 2010
- First submitted
- 8 Sep 2010
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Optimal Dose of Local Anesthetics for Patient Controlled Continuous Femoral Nerve Block With Sciatic Nerve Block After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01198340
- Acronym / sponsor ID
- TKAFEMORAL-2010
- Conditions
- Arthropathy of Knee Joint
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Okayama UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 10 Sep 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.
To evaluate an analgesic effect without basal administration of local anesthetics for patient-controlled femoral nerve block (with sciatic nerve block) after total knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With basal local anesthetics | Active comparator | Procedure: PC-FNB with basal administration of local anesthetics |
| Without basal local anesthetics | Experimental | Procedure: PC-FNB without basal local anesthetics |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients older than 20 yrs old scheduled for total knee arthroplasty
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| PC-FNB with basal administration of local anestheticsAlso: PC-FNB with basal ropivacaine administrationAdministration of 0.2% ropivacaine for femoral nerve block with 3 ml/h of basal dose, 5ml bolus by the patient, 60 minutes of lock out time. | Procedure or surgery | With basal local anesthetics |
| PC-FNB without basal local anestheticsAlso: PC-FAB without basal ropivacaine administrationAdministration of 0.2% ropivacaine for femoral nerve block without basal dose, with 8 ml bolus by the patient, 60 minutes of lockout time. | Procedure or surgery | Without basal local anesthetics |
Primary outcome
pain scores by use of numerous rating scale (NRS)
Time frame: 4 days after the surgery
1 secondary outcome
dose of local anesthetics
Time frame: 4 days after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
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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.
Hideki Taninishi, MD, PhD principal investigator
Okayama University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PC-FNB with basal administration of local anesthetics and PC-FNB without basal local anesthetics in people with Arthropathy of Knee Joint, run by Okayama University at 1 site in Japan.
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 1 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 22 Jul 2011. 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 Japan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hideki Taninishi, MD, PhD (81-86-235-7327, tanishi@ops.dti.ne.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain scores by use of numerous rating scale (NRS) (time frame: 4 days after the 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 22 Jul 2011.