Knee ArthroplastyPhase 4NCT01225484
Perioperative Analgesia After Knee Arthroplasty
A Phase 4 study testing Continuous femoral nerve block + periarticular infiltration and Intraarticular and periarticular ropivacaine in people with Knee Arthroplasty, run by Landeskrankenhaus Feldbach at 1 site in Austria.
Trial summary
The purpose of this study is to compare two accepted methods of pain control in knee arthroplasty surgery.The first method combines the periarticular injection of ropivacaine with continuous blockade of the femoral nerve.The second method uses periarticular infiltration of ropivacaine in combination with an bolus of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- Continuous femoral nerve block + periarticular infiltration and Intraarticular and periarticular ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2010to Oct 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective primary knee arthroplasty
- ASA I,II,\&III patients
- Spinal Anaesthesia
Who cannot join
- Patients refusing consent
- Contraindications to regional anaesthesia
- Preexisting neurological disease
- Alcohol or drug abuse
- Inability to use the outcome assessment tools
- Wheel chair or walker dependent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Analgetic Therapy After Knee Arthroplasty
The purpose of this study is to compare two accepted methods of pain control in knee arthroplasty surgery.The first method combines the periarticular injection of ropivacaine with continuous blockade of the femoral nerve.The second method uses periarticular infiltration of ropivacaine in combination with an bolus of ropivacaine into an intraarticular catheter placed intraoperatively followed by a continuous intraarticular infusion of ropivacaine. All patient will also receive a sustained-release oral opioid and oral rescue opioids determined by pain severity using the Visual Analog Scale (VAS)
- Conditions
- Knee Arthroplasty
- Being tested
- Continuous femoral nerve block + periarticular infiltration, Intraarticular and periarticular ropivacaine
- Keywords
- Knee arthroplasty, perioperative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous femoral nerve block + periarticular infiltrationProcedure or surgery
Also called CFNB plus periarticular infiltration
Initial bolus of ropivacaine 5mg/ml 30mls into the femoral-nerve-catheter preoperatively. Periarticular infiltration of ropivacaine 2mg/ml 150 mls intraoperatively. Continuous perineural infusion of ropivacaine 2mg/ml at a rate of 6 mls/hr postoperatively. Rate can be adjusted to achieve optimal pain control and avoid motor blockade.
Intraarticular and periarticular ropivacaineProcedure or surgery
Also called Intraarticular ropivacaine plus periarticular ropivavaine
Periarticular infiltration of 150 mls ropivacaine 2mg/ml intraoperatively, intraarticular injection of 40 mls ropivacaine 2 mg/ml at skin closure followed by infusion of ropivacaine 2 mg/ml at a rate of 4 mls/hr delivered by an intraarticular catheter until the morning of postoperative day 3.
| Study group | Role | What they receive |
|---|---|---|
| CFNB, periarticular infiltration | Active comparator | Not described Receives: Procedure: Continuous femoral nerve block + periarticular infiltration |
| Intraarticular catheter, periarticular infiltration | Active comparator | Not described Receives: Procedure: Continuous femoral nerve block + periarticular infiltration; Procedure: Intraarticular and periarticular ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static and dynamic pain scores (VAS)
Measured: 72 h
Secondary outcomes (1)
Maximum knee flexion (active/passive)>= 90°
Measured: 72 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Landeskrankenhaus Feldbach
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Graz
- Responsible party
- Principal investigator, Karl Trauner, Landeskrankenhaus Feldbach
- Investigators
- Karl Trauner, M.D., Principal investigator, LKH Feldbach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225484
- Sponsor's protocol ID
- 21-315 ex 09/10
- Status last verified
- Apr 2015
- First submitted
- 19 Oct 2010
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Analgetic Therapy After Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01225484
- Acronym / sponsor ID
- 21-315 ex 09/10
- Conditions
- Knee Arthroplasty
- Keywords
- Knee arthroplasty, perioperative analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Landeskrankenhaus FeldbachUniversity, hospital or other
- Collaborators
- Medical University of Graz
- Study start
- Oct 2010
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 21 Oct 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.
The purpose of this study is to compare two accepted methods of pain control in knee arthroplasty surgery.The first method combines the periarticular injection of ropivacaine with continuous blockade of the femoral nerve.The second method uses periarticular infiltration of ropivacaine in combination with an bolus of ropivacaine into an intraarticular catheter placed intraoperatively followed by a continuous intraarticular infusion of ropivacaine. All patient will also receive a sustained-release oral opioid and oral rescue opioids determined by pain severity using the Visual Analog Scale (VAS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CFNB, periarticular infiltration | Active comparator | Procedure: Continuous femoral nerve block + periarticular infiltration |
| Intraarticular catheter, periarticular infiltration | Active comparator | Procedure: Continuous femoral nerve block + periarticular infiltration, Procedure: Intraarticular and periarticular ropivacaine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective primary knee arthroplasty
- ASA I,II,\&III patients
- Spinal Anaesthesia
Key exclusion criteria (7 listed)
- Patients refusing consent
- Contraindications to regional anaesthesia
- Preexisting neurological disease
- Alcohol or drug abuse
- Inability to use the outcome assessment tools
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 |
|---|---|---|
| Continuous femoral nerve block + periarticular infiltrationAlso: CFNB plus periarticular infiltrationInitial bolus of ropivacaine 5mg/ml 30mls into the femoral-nerve-catheter preoperatively. Periarticular infiltration of ropivacaine 2mg/ml 150 mls intraoperatively. Continuous perineural infusion of ropivacaine 2mg/ml at a rate of 6 mls/hr postoperatively. Rate can be adjusted to achieve optimal pain control and avoid motor blockade. | Procedure or surgery | CFNB, periarticular infiltration, Intraarticular catheter, periarticular infiltration |
| Intraarticular and periarticular ropivacaineAlso: Intraarticular ropivacaine plus periarticular ropivavainePeriarticular infiltration of 150 mls ropivacaine 2mg/ml intraoperatively, intraarticular injection of 40 mls ropivacaine 2 mg/ml at skin closure followed by infusion of ropivacaine 2 mg/ml at a rate of 4 mls/hr delivered by an intraarticular catheter until the morning of postoperative day 3. | Procedure or surgery | Intraarticular catheter, periarticular infiltration |
Primary outcome
Static and dynamic pain scores (VAS)
Time frame: 72 h
1 secondary outcome
Maximum knee flexion (active/passive)>= 90°
Time frame: 72 h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
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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.
Karl Trauner, M.D. principal investigator
LKH Feldbach
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 Continuous femoral nerve block + periarticular infiltration and Intraarticular and periarticular ropivacaine in people with Knee Arthroplasty, run by Landeskrankenhaus Feldbach at 1 site in Austria.
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 7 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 9 Apr 2015. 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 Austria. 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 Karl Trauner, M.D. (+43 3152 899 3701, karl.trauner@lkh-feldbach.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static and dynamic pain scores (VAS) (time frame: 72 h). 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 9 Apr 2015.