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The purpose of this study is to compare different medication combinations used in a periarticular injection after total knee replacement surgery(TKR). A periarticular injection is an injection that is given into the tissues surrounding the knee joint. The injection is given while the patient is still in surgery.
The study will compare the level of pain management, length of hospital stay, range of motion and side effects from subjects receiving one of four different combinations of medication in a periarticular injection. The medications used in the injections are approved medications routinely used for pain management.
Approximately 160 subjects will participate in this study. The surgeon, study personnel, and patients will be blinded to the combination of medications each patient receives. The pharmacist will prepare the 4 different combinations of medications, randomize each patient to the particular combination of medications, and maintain the study drug documentation.
Data Collection:
Data will be collected from the patient's pre-operative office visit, up to six weeks post-operatively.
Variables
Pre-operative Collection:
Intra-operative Collection:
Post-operative Collection:
Data to be Collected by Physical Therapist: POD 1, 2, 3, Numerical Rating Scale (NRS) Pain with Ambulation
Treatment Periods Screening Visit Day 0 - Day of surgery Visit Day 1, 2, 3 (Post-operative days 1, 2, and 3) 6 Week visit in Office
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROP/EPI/TOR/CLO | Active Comparator | Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml) |
|
| ROP/EPI/TOR | Active Comparator | Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) |
|
| ROP/EPI/CLO | Active Comparator | Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml) |
|
| ROP/EPI | Active Comparator | Ropivacaine 5mg/ml (49.25ml) Epinephrine 1 mg/ml (0.5 ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Ropivacaine 5mg/ml (49.25 ml) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale (NRS) Pain Scores During Hospitalization. | Patient pain was assessed during hospitalization using the VAS Pain Scale, a numerical rating scale ranging from 0 (no pain) to 10 (severe pain). A lower score represents a better outcome. Pain was assessed preoperatively, 1 hour postoperatively in the post anesthesia unit, and then every 8 hours on the Orthopedic inpatient unit, for a duration of 2 days. | 2 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Narcotic Consumption During Hospitalization | A variety of pain medications were used after surgery to keep patients comfortable. Narcotic use was recorded as morphine equivalents. We report the mean narcotic consumption for each group for the day of surgery as well as post operative day 1,2, and 3. | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David F. Dalury, MD | Towson Orthpaedic Associates | Principal Investigator |
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Before assignment to groups all participants were screened for certain exclusion criteria including; pregnant/lactating women, allergies/contraindications to study medications/spinal anesthesia, drug/alcohol abuse, psychologic disorder, diagnosis of inflammatory arthritis, previous major surgery to operative knee, and simultaneous bilateral TKR's.
All patients scheduled for Total Knee Replacement (TKR), by the investigator and considered suitable for participation,were recruited for the study from Jan 2010 through June 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | ROP/EPI/TOR/CLO | Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml) |
| FG001 | REP/EPI/TOR | Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) |
| FG002 | REP/EPI/CLO | Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml) |
| FG003 | REP/EPI | Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ROP/EPI/TOR/CLO | Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml) |
| BG001 | ROP/EPI/TOR | Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) |
| 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 | Numerical Rating Scale (NRS) Pain Scores During Hospitalization. | Patient pain was assessed during hospitalization using the VAS Pain Scale, a numerical rating scale ranging from 0 (no pain) to 10 (severe pain). A lower score represents a better outcome. Pain was assessed preoperatively, 1 hour postoperatively in the post anesthesia unit, and then every 8 hours on the Orthopedic inpatient unit, for a duration of 2 days. | Posted | Mean | Standard Deviation | scores on a scale 0-10 | 2 days after surgery |
|
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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 | ROP/EPI/TOR/CLO | Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David F. Dalury, MD | Towson Orthopaedic Associates | 410-337-7900 | 1221 | ddalury@gmail.com |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D020911 | Ketorolac Tromethamine |
| D003000 | Clonidine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Toradol | Drug | Toradol 30mg/ml (1 ml) |
|
|
| Clonidine | Drug | Clonidine 0.1 mg/ml (0.08mg - 0.8 ml) |
|
|
| Epinephrine | Drug | Epinephrine 1 mg/ml (0.5 ml) |
|
|
| Knee Society Pain Scores at 6 Week Follow-up Appointment |
Patients were assessed for pain at their 6 week follow-up appointment using the Knee Society Rating Scale. Using this scale patients are given a pain score ranging from 0 (severe pain) to 50 (No Pain). This is determined as follows: No pain/50 points, Mild or occasional pain/45 points, pain with stairs only/40 points, pain with walking and stairs/30 points, Moderate/occasional pain/ 20 points,continual pain/10 points, severe pain/0 points. We report the mean score for each group. A higher score represents a better outcome. |
| 6 weeks after surgery |
| Withdrawal by Subject |
|
| BG002 | ROP/EPI/CLO | Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml) |
| BG003 | ROP/EPI | Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) |
| BG004 | 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 |
|
| OG002 | ROP/EPI/CLO | Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml) |
| OG003 | ROP/EPI | Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) |
|
|
| Secondary | Narcotic Consumption During Hospitalization | A variety of pain medications were used after surgery to keep patients comfortable. Narcotic use was recorded as morphine equivalents. We report the mean narcotic consumption for each group for the day of surgery as well as post operative day 1,2, and 3. | Posted | Mean | Standard Deviation | mg | 4 days |
|
|
|
| Secondary | Knee Society Pain Scores at 6 Week Follow-up Appointment | Patients were assessed for pain at their 6 week follow-up appointment using the Knee Society Rating Scale. Using this scale patients are given a pain score ranging from 0 (severe pain) to 50 (No Pain). This is determined as follows: No pain/50 points, Mild or occasional pain/45 points, pain with stairs only/40 points, pain with walking and stairs/30 points, Moderate/occasional pain/ 20 points,continual pain/10 points, severe pain/0 points. We report the mean score for each group. A higher score represents a better outcome. | Posted | Mean | Full Range | Scores on a scale 0-50 | 6 weeks after surgery |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | ROP/EPI/TOR | Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) | 0 | 40 | 0 | 40 |
| EG002 | ROP/EPI/CLO | Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml) | 0 | 40 | 0 | 40 |
| EG003 | ROP/EPI | Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) | 0 | 40 | 0 | 40 |
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| D012216 |
| Rheumatic Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D000588 |
| Amines |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-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 |
| Morphine Equivalent Post Operative Day 1 |
|
| Morphine Equivalent Post Operative Day 2 |
|
| Morphine Equivalent Post Operative Day 3 |
|