Arthroplasty, Replacement, KneeNCT00269529
Intraarticular Analgesia After Total Knee Arthroplasty, a Randomised Study
A study testing femoral nerve block and knee infiltration and injection via catheter in people with Arthroplasty, Replacement, Knee, run by University of Aarhus at 1 site in Denmark.
Trial summary
The study aims to compare two different kinds of pain treatment after total knee replacement (operation with artificial knee joint): 1) a large local injection in and around the knee, supplemented with injection the day after, or 2) the department's conventional pain treatment consisting of continuous nerve block in… Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- femoral nerve block and knee infiltration and injection via catheter
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2005to Mar 2006
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients planned for primary total knee arthroplasty due to primary arthrosis
Who cannot join
- Patients unable to provide informed consent
- patients with contraindications for spinal anesthesia
- patients with known hypersensitivity towards the used drugs
- patients with severe chronic neurogenic pain or sensitivity disorders in the leg to be operated
- patients who have undergone major bone surgery in the knee to be operated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Analgesia After Total Knee Arthroplasty. A Comparison of Continuous Femoral Block and Extensive Intraoperative Infiltration With Local Anesthetic Supplemented With Intraarticular Bolus the Following Day.
The study aims to compare two different kinds of pain treatment after total knee replacement (operation with artificial knee joint): 1) a large local injection in and around the knee, supplemented with injection the day after, or 2) the department's conventional pain treatment consisting of continuous nerve block in the groin.
Read the detailed description
Postoperative pain after total knee arthroplasty is moderate to severe and can be difficult to treat. The current use of femoral nerve block by ropivacain pump for 48 hours provides considerable analgesia, but patients often experience slight motor block, inhibiting rehabilitation, and pain in the posterior part of the knee, innervated by the sciatic nerve. This study compares femoral nerve block to a new technique, where ropivacaine, ketorolac and adrenalin is used to infiltrate the tissue in and around the knee joint during surgery, and is injected by an intraarticular catheter at 10 pm on the day of surgery and again at 10 am the day after. Data of pain scores, analgesia consumption, adverse effects and mobilisation is collected for the first four postoperative days.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- femoral nerve block, knee infiltration and injection via catheter
- Keywords
- postoperative pain, knee arthroplasty, analgesia, infiltration, femoral nerve block
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
femoral nerve blockProcedure or surgery
knee infiltration and injection via catheterProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
pain, by numeric rating scale
pain, by consumption of analgesics
side effects
return of function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startFeb 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies 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
- 80 participants
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Medical Research Council, Aarhus University Hospital
- Investigators
- Else Tønnesen, Professor, Principal investigator, Department of Anesthesiology, Aarhus University Hospital, Aarhus, DenmarkKjeld Søballe, Professor, Principal investigator, Orthopedic Center, Aarhus University Hospital, Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269529
- Sponsor's protocol ID
- 20050003
- Status last verified
- Oct 2006
- First submitted
- 22 Dec 2005
- Last updated
- 13 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia After Total Knee Arthroplasty. A Comparison of Continuous Femoral Block and Extensive Intraoperative Infiltration With Local Anesthetic Supplemented With Intraarticular Bolus the Following Day.
- ClinicalTrials.gov ID
- NCT00269529
- Acronym / sponsor ID
- 20050003
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- postoperative pain, knee arthroplasty, analgesia, infiltration, femoral nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Danish Medical Research Council, Aarhus University Hospital
- Study start
- Feb 2005
- Study completion
- Mar 2006
- First posted
- 23 Dec 2005 (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 study aims to compare two different kinds of pain treatment after total knee replacement (operation with artificial knee joint): 1) a large local injection in and around the knee, supplemented with injection the day after, or 2) the department's conventional pain treatment consisting of continuous nerve block in the groin.
Detailed description
Postoperative pain after total knee arthroplasty is moderate to severe and can be difficult to treat. The current use of femoral nerve block by ropivacain pump for 48 hours provides considerable analgesia, but patients often experience slight motor block, inhibiting rehabilitation, and pain in the posterior part of the knee, innervated by the sciatic nerve. This study compares femoral nerve block to a new technique, where ropivacaine, ketorolac and adrenalin is used to infiltrate the tissue in and around the knee joint during surgery, and is injected by an intraarticular catheter at 10 pm on the day of surgery and again at 10 am the day after. Data of pain scores, analgesia consumption, adverse effects and mobilisation is collected for the first four postoperative days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients planned for primary total knee arthroplasty due to primary arthrosis
Key exclusion criteria (5 listed)
- Patients unable to provide informed consent
- patients with contraindications for spinal anesthesia
- patients with known hypersensitivity towards the used drugs
- patients with severe chronic neurogenic pain or sensitivity disorders in the leg to be operated
- patients who have undergone major bone surgery in the knee to be operated
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 nerve block | Procedure or surgery | – |
| knee infiltration and injection via catheter | Procedure or surgery | – |
Primary outcome
pain, by numeric rating scale
pain, by consumption of analgesics
side effects
return of function
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 13 Oct 2006.
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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.
Else Tønnesen, Professor principal investigator
Department of Anesthesiology, Aarhus University Hospital, Aarhus, Denmark
Kjeld Søballe, Professor principal investigator
Orthopedic Center, Aarhus University Hospital, Aarhus, Denmark
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 nerve block and knee infiltration and injection via catheter in people with Arthroplasty, Replacement, Knee, run by University of Aarhus at 1 site in Denmark.
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 1 inclusion and 5 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 13 Oct 2006. 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 Denmark. 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?
pain, by numeric rating scale. The study lists 4 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 13 Oct 2006.