Total Knee ArthroplastyNCT01111513
The Influence of the Femoral Nerve Block on Quadriceps Strength
A study testing 48-hour ropivacaine infusions and Single dose ropivacaine in people with Total Knee Arthroplasty, run by Hopital de l'Enfant-Jesus at 1 site in Canada.
Trial summary
Total knee replacement is a frequent procedure in Québec's hospitals and the muscular strength of the quadriceps is the best indicator of the patient's functional recovery post surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- 48-hour ropivacaine infusions and Single dose ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years old
- men or women needing an elective total knee replacement surgery
Who cannot join
- unicompartmental arthroplasty
- revision surgery for knee arthroplasty
- previous surgery on same knee
- previous fracture of femur/patella with functional after-effects
- allergies or contraindication to any medication used during study or to local anaesthesia technique
- preexisting neurological deficit
Show all 13Show fewer
- severe anomaly of intracardiac conduction
- previous vascular surgery near the site of introduction of the catheter
- pregnancy or breastfeeding
- ASA IV or V14 class
- Men or women > 18 years old unfit to consent
- < 18 years old
- Refusal to sign consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of the Femoral Nerve Block on the Quadriceps Strength After Total Knee Replacement
Total knee replacement is a frequent procedure in Québec's hospitals and the muscular strength of the quadriceps is the best indicator of the patient's functional recovery post surgery. Thus, the importance of the patient's recovery leads to the evaluation of the influence of the femoral nerve block on the muscle strength.
The purpose of the study is to compare the short term and long term recuperation of the quadriceps' motor strength of after a total knee arthroplasty using different types of analgesics such as the continuous femoral nerve block, the single dose femoral nerve block and the systemic analgesic, a patient controlled analgesic pump.
- Conditions
- Total Knee Arthroplasty
- Being tested
- 48-hour ropivacaine infusions, Single dose ropivacaine, Patient controlled analgesics
- Keywords
- knee surgery, total knee arthroplasty, total knee replacement, ropivacaine, femoral nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
48-hour ropivacaine infusionsDrug
Also called ropivacaine, femoral block
Patients receive 20 ml of ropivacaine 0.5 % pre-operation through femoral block catheter, followed by ropivacaine infusions from 0.1 % to 0.1 ml/kg/hour for 48 hours.
Single dose ropivacaineDrug
Also called ropivacaine
Patients receive 20 ml of ropivacaine 0.5% pre-operation
Patient controlled analgesicsDrug
Also called analgesics
Patient controlled analgesics alone, no femoral block
| Study group | Role | What they receive |
|---|---|---|
| Continuous femoral block | Active comparator | Patients receive a continuous femoral block for 48 hours and they have patient controlled analgesics. Receives: Drug: 48-hour ropivacaine infusions |
| Single dose femoral block | Active comparator | Patients receive a single dose femoral block and have patient controlled analgesics. Receives: Drug: Single dose ropivacaine |
| Patient controlled analgesics | Active comparator | Patients do not receive a femoral block. They only have patient controlled analgesics. Receives: Drug: Patient controlled analgesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps strength measurement with Cybex machine
Evidence of the influence of the different types of analgesics on the strength of the quadriceps post surgery. Quadriceps strength will be evaluated in open chain and closed chain with the help of the Cybex machine.
Measured: 6 weeks after surgery
Quadriceps strength measurement with Cybex machine
Evidence of the influence of the different types of analgesics on the strength of the quadriceps post surgery. Quadriceps strength will be evaluated in open chain and closed chain with the help of the Cybex machine.
Measured: 6 months after surgery
Quadriceps strength measurements with Cybex machine
Evidence of the influence of the different types of analgesics on the strength of the quadriceps post surgery. Quadriceps strength will be evaluated in open chain and closed chain with the help of the Cybex machine.
Measured: 12 months after surgery
Secondary outcomes (5)
Overall functional recovery
The overall functional recovery of the patient will be evaluated considering the analgesic type using SF-36 and WOMAC questionnaires.
Measured: 6 weeks after surgery
Pain score on Visual Analog Scale (VAS)
Evaluation of the effectiveness of the analgesics on pain with VAS .
Measured: every 6 hour for the 48 hours following surgery
Hospital stay length
Evaluation of the hospital stay length after total knee replacement taking into account the different types of analgesics.
Measured: 4 to 7 days after surgery
Overall functional recovery
The overall functional recovery of the patient will be evaluated considering the analgesic type using SF-36 and WOMAC questionnaires.
Measured: 6 months after surgery
Overall functional recovery
The overall functional recovery of the patient will be evaluated considering the analgesic type using SF-36 and WOMAC questionnaires.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startNov 2007
- Primary completionMar 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital de l'Enfant-Jesus
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Pelet Stephane, Hopital de l'Enfant-Jesus
- Investigators
- Stéphane Pelet, MD, PhD, Principal investigator, Hôpital Enfant-JésusMichèle Angers, PhD, Principal investigator, Hôpital Enfant-Jésus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111513
- Sponsor's protocol ID
- PEJ-413
- Status last verified
- Dec 2012
- First submitted
- 21 Apr 2010
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Femoral Nerve Block on the Quadriceps Strength After Total Knee Replacement
- ClinicalTrials.gov ID
- NCT01111513
- Acronym / sponsor ID
- PEJ-413
- Conditions
- Total Knee Arthroplasty
- Keywords
- knee surgery, total knee arthroplasty, total knee replacement, ropivacaine, femoral nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Hopital de l'Enfant-JesusUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Nov 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 27 Apr 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.
Total knee replacement is a frequent procedure in Québec's hospitals and the muscular strength of the quadriceps is the best indicator of the patient's functional recovery post surgery. Thus, the importance of the patient's recovery leads to the evaluation of the influence of the femoral nerve block on the muscle strength.
The purpose of the study is to compare the short term and long term recuperation of the quadriceps' motor strength of after a total knee arthroplasty using different types of analgesics such as the continuous femoral nerve block, the single dose femoral nerve block and the systemic analgesic, a patient controlled analgesic pump.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous femoral block | Active comparator | Drug: 48-hour ropivacaine infusionsPatients receive a continuous femoral block for 48 hours and they have patient controlled analgesics. |
| Single dose femoral block | Active comparator | Drug: Single dose ropivacainePatients receive a single dose femoral block and have patient controlled analgesics. |
| Patient controlled analgesics | Active comparator | Drug: Patient controlled analgesicsPatients do not receive a femoral block. They only have patient controlled analgesics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- > 18 years old
- men or women needing an elective total knee replacement surgery
Key exclusion criteria (13 listed)
- unicompartmental arthroplasty
- revision surgery for knee arthroplasty
- previous surgery on same knee
- previous fracture of femur/patella with functional after-effects
- allergies or contraindication to any medication used during study or to local anaesthesia technique
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 |
|---|---|---|
| 48-hour ropivacaine infusionsAlso: ropivacaine, femoral blockPatients receive 20 ml of ropivacaine 0.5 % pre-operation through femoral block catheter, followed by ropivacaine infusions from 0.1 % to 0.1 ml/kg/hour for 48 hours. | Drug | Continuous femoral block |
| Single dose ropivacaineAlso: ropivacainePatients receive 20 ml of ropivacaine 0.5% pre-operation | Drug | Single dose femoral block |
| Patient controlled analgesicsAlso: analgesicsPatient controlled analgesics alone, no femoral block | Drug | Patient controlled analgesics |
Primary outcome
Quadriceps strength measurement with Cybex machine
Time frame: 6 weeks after surgery
Evidence of the influence of the different types of analgesics on the strength of the quadriceps post surgery. Quadriceps strength will be evaluated in open chain and closed chain with the help of the Cybex machine.
Quadriceps strength measurement with Cybex machine
Time frame: 6 months after surgery
Evidence of the influence of the different types of analgesics on the strength of the quadriceps post surgery. Quadriceps strength will be evaluated in open chain and closed chain with the help of the Cybex machine.
Quadriceps strength measurements with Cybex machine
Time frame: 12 months after surgery
Evidence of the influence of the different types of analgesics on the strength of the quadriceps post surgery. Quadriceps strength will be evaluated in open chain and closed chain with the help of the Cybex machine.
5 secondary outcomes
Overall functional recovery
Time frame: 6 weeks after surgery
Pain score on Visual Analog Scale (VAS)
Time frame: every 6 hour for the 48 hours following surgery
Hospital stay length
Time frame: 4 to 7 days after surgery
Overall functional recovery
Time frame: 6 months after surgery
Overall functional recovery
Time frame: 12 months after surgery
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 20 Dec 2012.
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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.
Stéphane Pelet, MD, PhD principal investigator
Hôpital Enfant-Jésus
Michèle Angers, 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 study testing 48-hour ropivacaine infusions and Single dose ropivacaine in people with Total Knee Arthroplasty, 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 2 inclusion and 13 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 20 Dec 2012. 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.
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?
Quadriceps strength measurement with Cybex machine (time frame: 6 weeks after surgery). The study lists 3 primary outcomes in all. 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 20 Dec 2012.