Osteoarthritis of the KneePhase 4NCT00562627
Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty
A Phase 4 study testing ropivacaine, adrenaline and ketorolac in people with Osteoarthritis of the Knee, run by Asker & Baerum Hospital at 1 site in Norway.
Trial summary
Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge. The aim of this study is to: 1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- ropivacaine, adrenaline and ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2007to Jul 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- patients at least 18 years of age
- scheduled for elective total knee arthroplasty
- ASA I-III
- signed written informed consent
Who cannot join
- age < 18
- ASA > III
- moderate or severe cardiac disease, bronchial asthma
- allergy against ropivacaine, ketorolac or morphine
- analgetic abuse
- pregnancy or nursing women
- severe psychiatric disease
- moderate to severe dementia
Trial locations and contacts
1 site in 1 country.
About this study
Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.
The aim of this study is to:
- Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
- Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.
Read the detailed description
Total knee arthroplasty (TKA) is increasingly common in the treatment of knee osteoarthritis. TKA is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.
Continuous epidural analgesia is often used for controlling pain after TKA. Recent studies describe a new method for pain control after total knee arthroplasty which consists of local infiltration with local anesthetics and adrenaline. This infiltrations can be combined with ketorolac and/or morphine. The aim of this study is to:
- Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
- Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- ropivacaine, adrenaline, ketorolac, morphine, fentanyl
- Keywords
- osteoarthritis, knee arthroplasty, local infiltration analgesia, TKA, epidural analgesia, operation, surgery
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineDrug
Also called Naropin
intraoperative and 1. postoperative day
adrenalineDrug
Also called Adrenalin, (epinephrine)
intraoperative LIA (IV and IA) and continuous EDA
ketorolacDrug
Also called Toradol
intraoperative and 1. postoperative day
morphineDrug
Also called Morfin
intraoperative
fentanylDrug
continuous postoperatively
bupivacaineDrug
Also called Marcain
continuous postoperatively
| Study group | Role | What they receive |
|---|---|---|
| LIA IV | Experimental | Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine Receives: Drug: ropivacaine; Drug: adrenaline; Drug: ketorolac; Drug: morphine |
| LIA IA | Experimental | Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine Receives: Drug: ropivacaine; Drug: adrenaline; Drug: ketorolac; Drug: morphine |
| EDA | Active comparator | standard continuous epidural analgesia Receives: Drug: adrenaline; Drug: fentanyl; Drug: bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at Rest (VAS)
VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain.
Measured: 48 hours postoperative
Secondary outcomes (2)
Opioid Use
Morphine used by patient controlled analgesia. Amount of used morphine during the first 48 hours after surgery were documented in the CRF by the pain nurses.
Measured: 48 hours postoperative
Time to Readiness for Discharge
Each postoperative day, discharge readiness was assessed by an orthopaedic surgeon, a pain nurse, a ward nurse, and a physiotherapist according to the following criteria: no evidence for surgical complications, VAS pain at rest ≤30 mm which is controlled by oral analgesics, ability to eat and drink, ability to walk with elbow crutches, and ability to climb ≥8 stairs.
Measured: up to 10 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionJun 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asker & Baerum Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ulrich J Spreng, MD, Principal investigator, Asker and Baerum Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562627
- Sponsor's protocol ID
- 2007-003030-41
- Other IDs
- EudraCT 2007-003030-41, REK 1.2007.1603
- Status last verified
- Aug 2011
- First submitted
- 21 Nov 2007
- Last updated
- 8 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Spreng UJ, Dahl V, Hjall A, Fagerland MW, Raeder J. High-volume local infiltration analgesia combined with intravenous or local ketorolac+morphine compared with epidural analgesia after total knee arthroplasty. Br J Anaesth. 2010 Nov;105(5):675-82. doi: 10.1093/bja/aeq232. Epub 2010 Aug 24.
PubMed 20736233
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00562627
- Acronym / sponsor ID
- 2007-003030-41
- Conditions
- Osteoarthritis of the Knee
- Keywords
- osteoarthritis, knee arthroplasty, local infiltration analgesia, TKA, epidural analgesia, operation, surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Asker & Baerum HospitalUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 22 Nov 2007 (estimated)
- Results
- Posted 8 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.
The aim of this study is to:
- Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
- Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.
Detailed description
Total knee arthroplasty (TKA) is increasingly common in the treatment of knee osteoarthritis. TKA is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.
Continuous epidural analgesia is often used for controlling pain after TKA. Recent studies describe a new method for pain control after total knee arthroplasty which consists of local infiltration with local anesthetics and adrenaline. This infiltrations can be combined with ketorolac and/or morphine. The aim of this study is to:
- Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
- Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LIA IV | Experimental | Drug: ropivacaine, Drug: adrenaline, Drug: ketorolac, Drug: morphineLocal infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine |
| LIA IA | Experimental | Drug: ropivacaine, Drug: adrenaline, Drug: ketorolac, Drug: morphineLocal infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine |
| EDA | Active comparator | Drug: adrenaline, Drug: fentanyl, Drug: bupivacainestandard continuous epidural analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients at least 18 years of age
- scheduled for elective total knee arthroplasty
- ASA I-III
- signed written informed consent
Key exclusion criteria (8 listed)
- age < 18
- ASA > III
- moderate or severe cardiac disease, bronchial asthma
- allergy against ropivacaine, ketorolac or morphine
- analgetic abuse
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 |
|---|---|---|
| ropivacaineAlso: Naropinintraoperative and 1. postoperative day | Drug | LIA IA, LIA IV |
| adrenalineAlso: Adrenalin, (epinephrine)intraoperative LIA (IV and IA) and continuous EDA | Drug | EDA, LIA IA, LIA IV |
| ketorolacAlso: Toradolintraoperative and 1. postoperative day | Drug | LIA IA, LIA IV |
| morphineAlso: Morfinintraoperative | Drug | LIA IA, LIA IV |
| fentanylcontinuous postoperatively | Drug | EDA |
| bupivacaineAlso: Marcaincontinuous postoperatively | Drug | EDA |
Primary outcome
Pain at Rest (VAS)
Time frame: 48 hours postoperative
VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain.
2 secondary outcomes
Opioid Use
Time frame: 48 hours postoperative
Time to Readiness for Discharge
Time frame: up to 10 days postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20736233Spreng UJ, Dahl V, Hjall A, Fagerland MW, Raeder J. High-volume local infiltration analgesia combined with intravenous or local ketorolac+morphine compared with epidural analgesia after total knee arthroplasty. Br J Anaesth. 2010 Nov;105(5):675-82. doi: 10.1093/bja/aeq232. Epub 2010 Aug 24.
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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.
Ulrich J Spreng, MD principal investigator
Asker and Baerum Hospital
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 ropivacaine, adrenaline and ketorolac in people with Osteoarthritis of the Knee, run by Asker & Baerum Hospital at 1 site in Norway.
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 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 8 Aug 2011. 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 Norway. 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?
Yes. Results are posted in the registry (first posted 8 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 at Rest (VAS) (time frame: 48 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00562627, which also lists 1 linked publication.
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 8 Aug 2011.