Osteoarthritis, KneePhase 4NCT00901628
Periarticular Multimodal Drug Injections in Total Knee Arthroplasty
A Phase 4 study testing ropivacaine, morphine sulfate and ketorolac in people with Osteoarthritis, Knee, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether periarticular multimodal drug injection (PMDI) would provide additional benefits in patients after total knee arthroplasty (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block, intra-venous patient controlled analgesia (IV-PCA)and… Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- ropivacaine, morphine sulfate and ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2008to Apr 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 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary osteoarthritis
- Scheduled for elective total knee arthroplasty
- Signed written informed consent
- Spinal anesthesia
Who cannot join
- Patients refusing consents
- inability to use the outcome assessment tools
- Contraindications to regional anesthesia
- severe cardiovascular disease
- allergy or contraindication to drugs used in this study
- pre-existing neurologic disease including psychiatric disorder
- drug abuser
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Joint Reconstruction Center, Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Efficacy and Safety of Periarticular Multimodal Drug Injections in Total Knee Arthroplasty
The purpose of this study is to determine whether periarticular multimodal drug injection (PMDI) would provide additional benefits in patients after total knee arthroplasty (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block, intra-venous patient controlled analgesia (IV-PCA)and preemptive oral medications. We hypothesized that PMDI would reduce pain level and consumption of PCA and acute pain rescuer and would provide better functional recovery and patient satisfaction. We also hypothesized that the incidence of side effects and complications of the PMDI would be similar to the No-PMDI.
Read the detailed description
The preemptive multimodal approaches are regarded as a current standard pain management protocol. Recently, periarticular multimodal drug injection (PMDI) has been considered to be one of the most effective and important component in multimodal approaches. Because the contemporary pain management protocol using the regional anesthesia, continuous femoral nerve block (FNB) and intravenous patient-controlled analgesia (PCA) has been proved significantly improved analgesic effects itself, little information whether the PMDI would provide additional pain relief under this pain management protocol is available. Also, because the safety of the high dose local anesthetics and narcotics has not been clarified, a selective application should be considered to patients who were expected to show better analgesia if there were certain patient related factors to predict the additional pain relief effect of the PMDI. Thus, this prospective double-blind randomized study was conducted to determine whether PMDI would provide additional benefits in patients after total knee arthroplasty (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block, IV-PCA and preemptive oral medications in terms of pain relief, consumption of PCA and acute pain rescuer, patients satisfaction, functional recovery, side effects and complications.
- Conditions
- Osteoarthritis, Knee
- Being tested
- ropivacaine, morphine sulfate, ketorolac, epinephrine, cefuroxime
- Keywords
- periarticular multimodal drug injection
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineDrug
300mg (0.75%, 40cc) intraoperative periarticular injection
morphine sulfateDrug
10mg intraoperative periarticular injection
ketorolacDrug
30 mg intraoperative periarticular injection
epinephrineDrug
300 microgram (1:1000) intraoperative periarticular injection
cefuroximeDrug
750mg intraoperative periarticular injection
| Study group | Role | What they receive |
|---|---|---|
| Periarticular Injection group | Experimental | Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime Receives: Drug: ropivacaine; Drug: morphine sulfate; Drug: ketorolac; Drug: epinephrine; Drug: cefuroxime |
| No Injection group | No intervention | usual postoperative care without periarticular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain( Visual Analog Scale )
An independent investigator who was blinded to randomization assessed pain level using 0 to 10 visual analog scale (VAS) that ranged from 0 (no pain) to 10 (worst imaginable pain)at the night after operation.
Measured: the night after surgery
Secondary outcomes (5)
Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery
Fentanyl based PCA consumption via PCA pump (microgram)
Measured: 24 hours postoperative
Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery
An independent investigator assessed participant number of postoperative nausea and vomiting during 24 hours after surgery. Nausea was defined as a subjective unpleasant sensation associated with awareness of the urge to vomit; and vomiting, as the forceful expulsion of gastric contents from the mouth.
Measured: 24 hours after surgery
the Proportion of Patients Who Were Satisfied With the Pain Management
Measured: postoperative 7 day
The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended
Measured: 24 hours postoperative
Maximal Flexion Angle Degree on Postoperative 7 Day
An independent investigator measured the maximal flexion angle (degree) of replaced knee with 28 centimeter armed goniometer on postoperative 7 day
Measured: postoperative 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startApr 2008
- Primary completionMar 2009
- Study completionApr 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.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Kyun Kim, Seoul National University Hospital
- Investigators
- Tae Kyun Kim, MD, PhD, Principal investigator, Joint Recontruction Center, Seoul National University Bundang hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901628
- Sponsor's protocol ID
- B-0804/056-021
- Status last verified
- Dec 2012
- First submitted
- 13 May 2009
- Last updated
- 25 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Periarticular Multimodal Drug Injections in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00901628
- Acronym / sponsor ID
- B-0804/056-021
- Conditions
- Osteoarthritis, Knee
- Keywords
- periarticular multimodal drug injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 14 May 2009 (estimated)
- Results
- Posted 25 Jan 2013
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 determine whether periarticular multimodal drug injection (PMDI) would provide additional benefits in patients after total knee arthroplasty (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block, intra-venous patient controlled analgesia (IV-PCA)and preemptive oral medications. We hypothesized that PMDI would reduce pain level and consumption of PCA and acute pain rescuer and would provide better functional recovery and patient satisfaction. We also hypothesized that the incidence of side effects and complications of the PMDI would be similar to the No-PMDI.
Detailed description
The preemptive multimodal approaches are regarded as a current standard pain management protocol. Recently, periarticular multimodal drug injection (PMDI) has been considered to be one of the most effective and important component in multimodal approaches. Because the contemporary pain management protocol using the regional anesthesia, continuous femoral nerve block (FNB) and intravenous patient-controlled analgesia (PCA) has been proved significantly improved analgesic effects itself, little information whether the PMDI would provide additional pain relief under this pain management protocol is available. Also, because the safety of the high dose local anesthetics and narcotics has not been clarified, a selective application should be considered to patients who were expected to show better analgesia if there were certain patient related factors to predict the additional pain relief effect of the PMDI. Thus, this prospective double-blind randomized study was conducted to determine whether PMDI would provide additional benefits in patients after total knee arthroplasty (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block, IV-PCA and preemptive oral medications in terms of pain relief, consumption of PCA and acute pain rescuer, patients satisfaction, functional recovery, side effects and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periarticular Injection group | Experimental | Drug: ropivacaine, Drug: morphine sulfate, Drug: ketorolac, Drug: epinephrine, Drug: cefuroximePeriarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime |
| No Injection group | No intervention | –usual postoperative care without periarticular injection |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of primary osteoarthritis
- Scheduled for elective total knee arthroplasty
- Signed written informed consent
- Spinal anesthesia
Key exclusion criteria (7 listed)
- Patients refusing consents
- inability to use the outcome assessment tools
- Contraindications to regional anesthesia
- severe cardiovascular disease
- allergy or contraindication to drugs used in this study
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 |
|---|---|---|
| ropivacaine300mg (0.75%, 40cc) intraoperative periarticular injection | Drug | Periarticular Injection group |
| morphine sulfate10mg intraoperative periarticular injection | Drug | Periarticular Injection group |
| ketorolac30 mg intraoperative periarticular injection | Drug | Periarticular Injection group |
| epinephrine300 microgram (1:1000) intraoperative periarticular injection | Drug | Periarticular Injection group |
| cefuroxime750mg intraoperative periarticular injection | Drug | Periarticular Injection group |
Primary outcome
Pain( Visual Analog Scale )
Time frame: the night after surgery
An independent investigator who was blinded to randomization assessed pain level using 0 to 10 visual analog scale (VAS) that ranged from 0 (no pain) to 10 (worst imaginable pain)at the night after operation.
5 secondary outcomes
Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery
Time frame: 24 hours postoperative
Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery
Time frame: 24 hours after surgery
the Proportion of Patients Who Were Satisfied With the Pain Management
Time frame: postoperative 7 day
The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended
Time frame: 24 hours postoperative
Maximal Flexion Angle Degree on Postoperative 7 Day
Time frame: postoperative 7 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tae Kyun Kim, MD, PhD principal investigator
Joint Recontruction Center, Seoul National University Bundang 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, morphine sulfate and ketorolac in people with Osteoarthritis, Knee, run by Seoul National University Hospital at 1 site in South Korea.
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 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: finished, as of the sponsor's last update on 25 Jan 2013. 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 South Korea. 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 25 Jan 2013). 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( Visual Analog Scale ) (time frame: the night 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 25 Jan 2013.