MorbidityNCT01631799
Outcome of Patients After Total Knee Replacement: A Comparison of Femoral Nerve Block and Epidural Anesthesia
A study testing Femoral catheter and Epidural catheter in people with Morbidity and Mortality, run by University of Rostock at 1 site in Germany.
Trial summary
Total knee replacement is very common in Germany. After surgery patients have severe pain in the knee; initiation of the physiotherapy, however, is important in the first three days after surgery. Continuous femoral blockade and continuous (lumbar) epidural analgesia are commonly used after surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Morbidity, Mortality, Complications
- What is being tested?
- Femoral catheter and Epidural catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2008to Dec 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 -80 years
- ASA I-III
- Surgery: total knee replacement
- informed consent
Who cannot join
- obesity
- contraindication for epidural anesthesia
- coagulation disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome of Patients After Total Knee Replacement: A Comparison of Femoral Nerve Block and Epidural Anesthesia. A Randomized, Controlled Trial
Total knee replacement is very common in Germany. After surgery patients have severe pain in the knee; initiation of the physiotherapy, however, is important in the first three days after surgery. Continuous femoral blockade and continuous (lumbar) epidural analgesia are commonly used after surgery. Both methods are used in Germany. Both methods have advantages and disadvantages. We wanted to answer the question which method of analgesia - after total knee replacement - is better concerning complications and function (after 3 months) ?
- Conditions
- Morbidity, Mortality, Complications, Function
- Being tested
- Femoral catheter, Epidural catheter
- Keywords
- epidural anesthesia, femoral block, patient control analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral catheterDevice
Femoral catheter was inserted at the beginning of surgery. After surgery ropivacaine was administered continuously for three days. In addition, patients received piritramide via patient-controlled analgesia. The amount of ropivacaine was measured.
Epidural catheterDevice
The epidural catheter was inserted at the beiginning of surgery. After surgery ropivacaine was applied continuously for three days. In addition, patients received piritramide via patient controlled analgesia. The amount of ropivacaine was measured.
| Study group | Role | What they receive |
|---|---|---|
| Femoral Block | Active comparator | One group received a femoral block for analgesia after surgery. Ropivacain was administered continuously for three days. Receives: Device: Femoral catheter |
| Epidural Analgesia | Active comparator | One group received an epidural analgesia after surgery for three days. Receives: Device: Epidural catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function
3 months after surgery the function of the total knee replacement is testd
Measured: 3 months after surgery
Secondary outcomes (2)
Mortality
Measured: 28 days after surgery
Morbidity
Measured: 28 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startOct 2008
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MorbidityStudies 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
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Mencke, University of Rostock
- Investigators
- Thomas Mencke, PD Dr., Principal investigator, Dep. of Anesthesia, University of Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631799
- Sponsor's protocol ID
- A 40 2008
- Status last verified
- Jun 2012
- First submitted
- 27 Jun 2012
- Last updated
- 29 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Patients After Total Knee Replacement: A Comparison of Femoral Nerve Block and Epidural Anesthesia. A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01631799
- Acronym / sponsor ID
- A 40 2008
- Conditions
- Morbidity, Mortality, Complications, Function
- Keywords
- epidural anesthesia, femoral block, patient control analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Jun 2012 (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 very common in Germany. After surgery patients have severe pain in the knee; initiation of the physiotherapy, however, is important in the first three days after surgery. Continuous femoral blockade and continuous (lumbar) epidural analgesia are commonly used after surgery. Both methods are used in Germany. Both methods have advantages and disadvantages. We wanted to answer the question which method of analgesia - after total knee replacement - is better concerning complications and function (after 3 months) ?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral Block | Active comparator | Device: Femoral catheterOne group received a femoral block for analgesia after surgery. Ropivacain was administered continuously for three days. |
| Epidural Analgesia | Active comparator | Device: Epidural catheterOne group received an epidural analgesia after surgery for three days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 -80 years
- ASA I-III
- Surgery: total knee replacement
- informed consent
Key exclusion criteria (3 listed)
- obesity
- contraindication for epidural anesthesia
- coagulation disorders
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 |
|---|---|---|
| Femoral catheterFemoral catheter was inserted at the beginning of surgery. After surgery ropivacaine was administered continuously for three days. In addition, patients received piritramide via patient-controlled analgesia. The amount of ropivacaine was measured. | Device | Femoral Block |
| Epidural catheterThe epidural catheter was inserted at the beiginning of surgery. After surgery ropivacaine was applied continuously for three days. In addition, patients received piritramide via patient controlled analgesia. The amount of ropivacaine was measured. | Device | Epidural Analgesia |
Primary outcome
Function
Time frame: 3 months after surgery
3 months after surgery the function of the total knee replacement is testd
2 secondary outcomes
Mortality
Time frame: 28 days after surgery
Morbidity
Time frame: 28 days 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 29 Jun 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.
Thomas Mencke, PD Dr. principal investigator
Dep. of Anesthesia, University of Rostock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral catheter and Epidural catheter in people with Morbidity and Mortality, run by University of Rostock 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 4 inclusion and 3 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 29 Jun 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 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?
Function (time frame: 3 months after 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 29 Jun 2012.