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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periarticular Injection group | Experimental | Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime |
|
| No Injection group | No Intervention | usual postoperative care without periarticular injection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ropivacaine | Drug | 300mg (0.75%, 40cc) intraoperative periarticular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | the night after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery | Fentanyl based PCA consumption via PCA pump (microgram) | 24 hours postoperative |
| Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tae Kyun Kim, MD, PhD | Joint Recontruction Center, Seoul National University Bundang hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joint Reconstruction Center, Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
no participant was excluded before assignment
101 patients who were scheduled for unilateral total knee arthroplasty recruitment at Joint Reconstruction Center, Seoul National University Bundang hospital from April 2008 to March 2009 were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | Periarticular Injection Group | Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime |
| FG001 | No Injection Group | usual postoperative care using the continuous femoral nerve block, IV-PCA and preemptive oral medications without periarticular injection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Periarticular Injection Group | Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime |
| BG001 | No Injection Group | usual postoperative care without periarticular injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | the night after surgery |
|
within postoperative 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Periarticular Injection Group | Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| participant number of postoperative wound infection | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | A blinded investigator evaluated postoperative wound at 1 month after surgery, and assessed incidence of postoperative wound complication. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tae Kyun Kim | Joint Reconstruction Center, Seoul National University Bundang Hospital | 82-31-787-7196 | osktk@snubh.org |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D009020 | Morphine |
| D020910 | Ketorolac |
| D004837 | Epinephrine |
| D002444 | Cefuroxime |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| morphine sulfate | Drug | 10mg intraoperative periarticular injection |
|
| ketorolac | Drug | 30 mg intraoperative periarticular injection |
|
| epinephrine | Drug | 300 microgram (1:1000) intraoperative periarticular injection |
|
| cefuroxime | Drug | 750mg intraoperative periarticular injection |
|
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. |
| 24 hours after surgery |
| the Proportion of Patients Who Were Satisfied With the Pain Management | postoperative 7 day |
| The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended | 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 | postoperative 7 day |
| peroneal nerve palsy |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery | Fentanyl based PCA consumption via PCA pump (microgram) | Posted | Mean | Standard Deviation | microgram | 24 hours postoperative |
|
|
|
| Secondary | 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. | Posted | Number | participants | 24 hours after surgery |
|
|
|
| Secondary | the Proportion of Patients Who Were Satisfied With the Pain Management | Posted | Number | participants | postoperative 7 day |
|
|
|
| Secondary | The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended | Posted | Number | participants | 24 hours postoperative |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | degree | postoperative 7 day |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | No Injection Group | usual postoperative care without periarticular injection | 0 | 52 | 0 | 52 |
|
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| D012216 |
| Rheumatic Diseases |
| D000588 |
| Amines |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |