Total Knee ReplacementPhase 1/2TKRNCT00910013
Femoral Block With or Without Ropivacaine for Analgesia After Total Knee Replacement (TKR)
A Phase 1/2 study testing Ropivacaine in people with Total Knee Replacement, run by Hopital de l'Enfant-Jesus at 1 site in Canada.
Trial summary
Total knee replacement is a painful procedure. Many solutions have been proposed to diminish the post-operative doses of narcotics, including nerve blocks. The purpose of the study is to compare if the adjunction of intra-articular ropivacaine to a femoral block is more effective on narcotics consumption than the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Ropivacaine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2006to Mar 2008
- Phase
- Phase 1/2
- 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
- Primary total knee replacement
- Age > 18 years old
- Accept the study
Who cannot join
- Revision surgery
- Use of anticoagulants drugs
- Neurologic disorder
- Unable to sign consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial Comparing the Efficacy on Post-operative Analgesia of Intra-articular Ropivacaine Added to a Femoral Block After Total Knee Replacement
Total knee replacement is a painful procedure. Many solutions have been proposed to diminish the post-operative doses of narcotics, including nerve blocks.
The purpose of the study is to compare if the adjunction of intra-articular ropivacaine to a femoral block is more effective on narcotics consumption than the block alone after TKR.
- Conditions
- Total Knee Replacement
- Being tested
- Ropivacaine
- Keywords
- TKR, Femoral block, Ropivacaïne, intra-articular ropivacaïne, post-operative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
0.5% intra-articular ropivacaïne (20cc)
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine + femoral block | Experimental | After the surgery is proceeded and after the closure of the joint capsule, 20 cc of ropivacaine 0.5% is inserted intra-articular through a catheter. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narcotic consumption per 24 hours after surgery (mg/kg)
Measured: 48 hours
Secondary outcomes (1)
VAS score at 24 hours
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study startApr 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital de l'Enfant-Jesus
- Sponsor type
- University, hospital or other
- Investigators
- Dr Stéphane Pelet, MD,PhD, Principal investigator, Hôpital Enfant-Jésus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910013
- Sponsor's protocol ID
- PEJ-340
- Acronym
- TKR
- Status last verified
- May 2009
- First submitted
- 28 May 2009
- Last updated
- 28 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing the Efficacy on Post-operative Analgesia of Intra-articular Ropivacaine Added to a Femoral Block After Total Knee Replacement
- ClinicalTrials.gov ID
- NCT00910013
- Acronym / sponsor ID
- TKR / PEJ-340
- Conditions
- Total Knee Replacement
- Keywords
- TKR, Femoral block, Ropivacaïne, intra-articular ropivacaïne, post-operative analgesia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hopital de l'Enfant-JesusUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 29 May 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.
Total knee replacement is a painful procedure. Many solutions have been proposed to diminish the post-operative doses of narcotics, including nerve blocks.
The purpose of the study is to compare if the adjunction of intra-articular ropivacaine to a femoral block is more effective on narcotics consumption than the block alone after TKR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine + femoral block | Experimental | Drug: RopivacaineAfter the surgery is proceeded and after the closure of the joint capsule, 20 cc of ropivacaine 0.5% is inserted intra-articular through a catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary total knee replacement
- Age > 18 years old
- Accept the study
Key exclusion criteria (4 listed)
- Revision surgery
- Use of anticoagulants drugs
- Neurologic disorder
- Unable to sign consent form
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 |
|---|---|---|
| Ropivacaine0.5% intra-articular ropivacaïne (20cc) | Drug | Ropivacaine + femoral block |
Primary outcome
Narcotic consumption per 24 hours after surgery (mg/kg)
Time frame: 48 hours
1 secondary outcome
VAS score at 24 hours
Time frame: 48 hours
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 28 Feb 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.
Dr Stéphane Pelet, MD,PhD principal investigator
Hôpital Enfant-Jésus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ropivacaine in people with Total Knee Replacement, run by Hopital de l'Enfant-Jesus at 1 site in Canada.
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 4 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 28 Feb 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 Canada. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Narcotic consumption per 24 hours after surgery (mg/kg) (time frame: 48 hours). 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 28 Feb 2011.