Total Knee ArthroplastyNCT02125903
Comparison of Continuous Femoral Nerve Block and Adductor Canal Block After Total Knee Replacement Therapy
A study testing Ropivacaine in people with Total Knee Arthroplasty and Total Knee Replacement, run by Philipps University Marburg at 1 site in Germany.
Trial summary
The blockade of the femoral nerve (FNB) is the most common postoperative pain therapy after total knee replacement. Because of motor-driven weakness of the quadriceps muscle induced by femoral nerve block mobilization of Patients is difficult even dangerous (falls) and hospital stays are extended. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty, Total Knee Replacement, Femoral Nerve Block
- What is being tested?
- Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- May 2013to Nov 2014
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with knee replacement therapy and general anaesthesia
- informed consent
- preoperative "timed up and go" test performable
Who cannot join
- emergency patients
- BMI > 40 kg/m2
- American Society of Anaesthesiologists physical status (ASA) 4-5
- severe chronic obstructive pulmonary disease (COPD)
- rheumatic arthritis, diabetic Polyneuropathy, M. Parkinson
- nerve injury of lumbosacral plexus
- coagulopathy with bleeding tendency
- not capable of speaking or understanding german or english
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Marburg Department of Anaesthesia And Intensive Care Medicine
Marburg, 35037
About this study
Official title: Randomized Controlled Study: Comparison of Continuous Femoral Nerve Block and Adductor Canal Block After Total Knee Replacement Therapy Relating to Early Mobilization and Analgesia
The blockade of the femoral nerve (FNB) is the most common postoperative pain therapy after total knee replacement. Because of motor-driven weakness of the quadriceps muscle induced by femoral nerve block mobilization of Patients is difficult even dangerous (falls) and hospital stays are extended.
An alternative method could be an adductor canal block (ACB). Anatomical studies of the adductor canal demonstrated that the adductor canal contains the saphenous nerve, a pure sensory nerve for medial and anterior aspects of the knee and the tibia without any motor function.
Read more
This prospective, double-blinded, randomized study investigates the effect of FNB and ACB on quadriceps motor weakness and analgesia determined by Numeric Rating Scale (NRS).
We expect the ACB to be superior in muscle strength but equal in pain score. Both groups receive an additional anterior sciatic nerve block for complete sensory block of the operated knee
- Conditions
- Total Knee Arthroplasty, Total Knee Replacement, Femoral Nerve Block, Adductor Canal Block
- Being tested
- Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Regional Anesthesia performed with 0.375% Ropivacaine 15ml (56,25mg)
| Study group | Role | What they receive |
|---|---|---|
| Continuous Adductor Canal Block (CACB) | Active comparator | Continuous Adductor Canal block performed with:
loading dose 0,375% Ropivacaine 15ml (56,25mg) start infusion 0,2% Ropivacaine 6ml/h
Procedure: Femoral Nerve Block. Adductor Canal Block Drug: Ropivacaine Receives: Drug: Ropivacaine |
| Continuous Femoral Nerve Block (CFNB) | Active comparator | Continuous Femoral Nerve Block performed with:
loading dose 0,375% Ropivacaine 15ml (56,25mg) start infusion 0,2% Ropivacaine 6ml/h
Procedure: Femoral Nerve Block. Adductor Canal Block Drug: Ropivacaine Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed-Up and Go-test for mobility evaluation
The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.
Measured: third postoperative day
Secondary outcomes (6)
Pain Scores
Numeric Rating Scale (NRS), 0-10 for Rest / Stress. in Addition total Body NRS Pain
Measured: 6, 24, 48, 72 hours postoperative
Quadriceps strength
Numeric Scale (0-5)
Measured: 6, 24, 28, 72 hours postoperative
Ropivacaine consumption (each catheter)
Measurement of the total amount
Measured: 24, 48, 72 hours postoperative
CAS (Cumulated Ambulation Score)
Cumulated Ambulation Score is calculated with routine data. Measurement for ambulation ability
Measured: 24,48,72 hours postoperative
Mobility Score (MoSc)
Is calculated with routine data. Measurement for overall mobilization (none- passive mobilization, sitting, standing, walking with walking device, walkin free or with crutches)
Measured: 24,48,72 hours postoperative
Analgesic regimen
Documentation of analgesic prescriptions and rescue medications during postoperative course
Measured: preop and 0, 6 , 24, 48, 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionNov 2014
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karolin Piechowiak, Philipps University Marburg
- Investigators
- Karolin Piechowiak, Dr, Study director, Dept. of Anesthesia And Intensiv Care Medicine University of MarburgThorsten Steinfeldt, Prof Dr, Study director, Dept. of Anesthesia And Intensive Care Medicine University of MarburgThomas Wiesmann, Dr, Study director, Dept. of Anesthesia And Intensive Care Medicine University of Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125903
- Sponsor's protocol ID
- AZ 06/13
- Status last verified
- Jan 2015
- First submitted
- 5 Feb 2014
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study: Comparison of Continuous Femoral Nerve Block and Adductor Canal Block After Total Knee Replacement Therapy Relating to Early Mobilization and Analgesia
- ClinicalTrials.gov ID
- NCT02125903
- Acronym / sponsor ID
- AZ 06/13
- Conditions
- Total Knee Arthroplasty, Total Knee Replacement, Femoral Nerve Block, Adductor Canal Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 29 Apr 2014 (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 blockade of the femoral nerve (FNB) is the most common postoperative pain therapy after total knee replacement. Because of motor-driven weakness of the quadriceps muscle induced by femoral nerve block mobilization of Patients is difficult even dangerous (falls) and hospital stays are extended.
An alternative method could be an adductor canal block (ACB). Anatomical studies of the adductor canal demonstrated that the adductor canal contains the saphenous nerve, a pure sensory nerve for medial and anterior aspects of the knee and the tibia without any motor function.
This prospective, double-blinded, randomized study investigates the effect of FNB and ACB on quadriceps motor weakness and analgesia determined by Numeric Rating Scale (NRS).
We expect the ACB to be superior in muscle strength but equal in pain score. Both groups receive an additional anterior sciatic nerve block for complete sensory block of the operated knee
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Adductor Canal Block (CACB) | Active comparator | Drug: RopivacaineContinuous Adductor Canal block performed with: loading dose 0,375% Ropivacaine 15ml (56,25mg) start infusion 0,2% Ropivacaine 6ml/h Procedure: Femoral Nerve Block. Adductor Canal Block Drug: Ropivacaine |
| Continuous Femoral Nerve Block (CFNB) | Active comparator | Drug: RopivacaineContinuous Femoral Nerve Block performed with: loading dose 0,375% Ropivacaine 15ml (56,25mg) start infusion 0,2% Ropivacaine 6ml/h Procedure: Femoral Nerve Block. Adductor Canal Block Drug: Ropivacaine |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with knee replacement therapy and general anaesthesia
- informed consent
- preoperative "timed up and go" test performable
Key exclusion criteria (8 listed)
- emergency patients
- BMI > 40 kg/m2
- American Society of Anaesthesiologists physical status (ASA) 4-5
- severe chronic obstructive pulmonary disease (COPD)
- rheumatic arthritis, diabetic Polyneuropathy, M. Parkinson
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 |
|---|---|---|
| RopivacaineRegional Anesthesia performed with 0.375% Ropivacaine 15ml (56,25mg) | Drug | Continuous Adductor Canal Block (CACB), Continuous Femoral Nerve Block (CFNB) |
Primary outcome
Timed-Up and Go-test for mobility evaluation
Time frame: third postoperative day
The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.
6 secondary outcomes
Pain Scores
Time frame: 6, 24, 48, 72 hours postoperative
Quadriceps strength
Time frame: 6, 24, 28, 72 hours postoperative
Ropivacaine consumption (each catheter)
Time frame: 24, 48, 72 hours postoperative
CAS (Cumulated Ambulation Score)
Time frame: 24,48,72 hours postoperative
Mobility Score (MoSc)
Time frame: 24,48,72 hours postoperative
Analgesic regimen
Time frame: preop and 0, 6 , 24, 48, 48 hours postoperative
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 26 Jan 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.
Karolin Piechowiak, Dr study director
Dept. of Anesthesia And Intensiv Care Medicine University of Marburg
Thorsten Steinfeldt, Prof Dr study director
Dept. of Anesthesia And Intensive Care Medicine University of Marburg
Thomas Wiesmann, Dr study director
Dept. of Anesthesia And Intensive Care Medicine University of Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine in people with Total Knee Arthroplasty and Total Knee Replacement, run by Philipps University Marburg at 1 site in Germany.
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 8 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 26 Jan 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 Germany. 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?
Timed-Up and Go-test for mobility evaluation (time frame: third postoperative day). 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 26 Jan 2015.