Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Hypothesis: Ropivacaine, morphine and ketorolac injected after knee arthroscopy is as effective as this solution plus ropivacaine administered intra-articularly for twenty-four hours.
Three groups were assigned random patients, each group provided a different method of pain medication in order to determine the effectiveness of each treatment.
Arthroscopic knee patients were randomized to 1 of 3 groups. A) 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; B) an identical solution plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour; C) an identical solution and no pain pump. Pain level, the amount of pain medication used and time to discharge were recorded. Clinical and radiographic evaluation was performed at nine months after surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pain pump , injectable medication | Experimental | 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; |
|
| saline pain pump , injectable medication | Active Comparator | 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour |
|
| injectable medication only | Active Comparator | 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pain pump containing ropivacaine | Device | 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score 8 Hours Post-operativley | Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). | 8 hours post surgery |
| Pain Scale | Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). | 24 hours post surgery |
| Pain Scale | Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). | 48 hours post-surgery |
| Pain Scale | Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). | 72 hours post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Narcotic Pills and Morphine Sulfate Used | Pill count | In recovery room |
| Number of Narcotic Pills and Morphine Sulfate Used | Pill Count |
Not provided
Inclusion Criteria: All subjects who underwent:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Albert W Pearsall, MD | University of South Alabama | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pain Pump , Injectable Medication | 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour |
| FG001 | Saline Pain Pump , Injectable Medication | 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour |
| FG002 | Injectable Medication Only | 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump. ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pain Pump , Injectable Medication | 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Score 8 Hours Post-operativley | Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). | Posted | Mean | Standard Deviation | units on a scale | 8 hours post surgery |
|
At 12 months post-operatively
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pain Pump , Injectable Medication | 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Office of Research Compliance | University of South Alabama | 251-460-7573 | swhite@southalabama.edu |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D010147 | Pain Measurement |
| D000077212 | Ropivacaine |
| D020910 | Ketorolac |
| D009020 | Morphine |
| D013431 | Sulfates |
| ID | Term |
|---|---|
| D009460 | Neurologic Examination |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| saline pain pump with injectable medication | Device | 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour |
|
|
| ropivacaine, ketorolac , morphine sulfate | Drug | 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected |
|
|
| Post surgery day 1 |
| Number of Narcotic Pills and Morphine Sulfate Used | Post surgery day 2 |
| Number of Narcotic Pills and Morphine Sulfate Used | Post surgery day 3 |
| BG001 | Saline Pain Pump , Injectable Medication | 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour |
| BG002 | Injectable Medication Only | 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump. ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Saline Pain Pump , Injectable Medication |
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour |
| OG002 | Injectable Medication Only | 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump. ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected |
|
|
| Primary | Pain Scale | Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). | Posted | Mean | Standard Deviation | units on a scale | 24 hours post surgery |
|
|
|
| Primary | Pain Scale | Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). | Posted | Mean | Standard Deviation | units on a scale | 48 hours post-surgery |
|
|
|
| Primary | Pain Scale | Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). | Posted | Mean | Standard Deviation | units on a scale | 72 hours post surgery |
|
|
|
| Secondary | Number of Narcotic Pills and Morphine Sulfate Used | Pill count | Posted | Mean | Standard Deviation | Pills | In recovery room |
|
|
|
| Secondary | Number of Narcotic Pills and Morphine Sulfate Used | Pill Count | Posted | Mean | Standard Deviation | Number of pills | Post surgery day 1 |
|
|
|
| Secondary | Number of Narcotic Pills and Morphine Sulfate Used | Posted | Mean | Standard Deviation | Number of pills | Post surgery day 2 |
|
|
|
| Secondary | Number of Narcotic Pills and Morphine Sulfate Used | Posted | Mean | Standard Deviation | number of pills | Post surgery day 3 |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Saline Pain Pump , Injectable Medication | 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | Injectable Medication Only | 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump. ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected | 0 | 15 | 0 | 15 | 0 | 15 |
Not provided
Not provided
Not provided
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| Title | Measurements |
|---|---|
|