Pain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEpain 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
DEVICEsaline 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
DRUGropivacaine, ketorolac , morphine sulfate
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
Sponsors
University of South Alabama
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All subjects who underwent: * knee arthroscopy + synovectomy * knee arthroscopy + partial or complete meniscectomy * knee arthroscopy + chondroplasty * knee arthroscopy + microfracture * knee arthroscopy + autologous osteoarticular transplantation
Exclusion criteria
* A surgical procedure that required an incision other then an arthroscopic portal * A surgical procedure within the same joint within ninety days * A acute or chronic knee infection * Any diagnosis of complex regional pain syndrome * A known allergy to one of the study drugs * A documented history of narcotic use * A score of less than two standard deviation on the SF-12 mental component * Any major systemic or cardiac illness (heart failure, uncontrolled angina, bifascicular blocks, renal insufficiency, or liver disease) * Under the age of eighteen years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score 8 Hours Post-operativley | 8 hours post surgery | 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). |
| Pain Scale | 24 hours post surgery | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Narcotic Pills and Morphine Sulfate Used | In recovery room | Pill count |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 16 |
| 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 | 17 |
| 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 | 15 |
| Total | 48 |
Baseline characteristics
| Characteristic | Saline Pain Pump , Injectable Medication | Injectable Medication Only | Total | Pain Pump , Injectable Medication |
|---|---|---|---|---|
| Age, Continuous | 51 years STANDARD_DEVIATION 0.9 | 49.9 years STANDARD_DEVIATION 0.9 | 51 years STANDARD_DEVIATION 0.9 | 51 years STANDARD_DEVIATION 0.9 |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment United States | 17 participants | 15 participants | 48 participants | 16 participants |
| Sex/Gender, Customized Female | 10 participants | 8 participants | 24 participants | 6 participants |
| Sex/Gender, Customized Male | 7 participants | 7 participants | 24 participants | 10 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 17 | 0 / 15 |
| other Total, other adverse events | 0 / 16 | 0 / 17 | 0 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 17 | 0 / 15 |
Outcome results
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).
Time frame: 24 hours post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pain Pump , Injectable Medication | Pain Scale | 1.75 units on a scale | Standard Deviation 0.16 |
| Saline Pain Pump , Injectable Medication | Pain Scale | 3.23 units on a scale | Standard Deviation 0.16 |
| Injectable Medication Only | Pain Scale | 3.06 units on a scale | Standard Deviation 0.16 |
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).
Time frame: 48 hours post-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pain Pump , Injectable Medication | Pain Scale | 1.81 units on a scale | Standard Deviation 0.14 |
| Saline Pain Pump , Injectable Medication | Pain Scale | 3.17 units on a scale | Standard Deviation 0.14 |
| Injectable Medication Only | Pain Scale | 2.26 units on a scale | Standard Deviation 0.14 |
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).
Time frame: 72 hours post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pain Pump , Injectable Medication | Pain Scale | 3.3 units on a scale | Standard Deviation 0.46 |
| Saline Pain Pump , Injectable Medication | Pain Scale | 4.05 units on a scale | Standard Deviation 0.46 |
| Injectable Medication Only | Pain Scale | 3.13 units on a scale | Standard Deviation 0.46 |
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).
Time frame: 8 hours post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pain Pump , Injectable Medication | Pain Score 8 Hours Post-operativley | 2.5 units on a scale | Standard Deviation 0.3282 |
| Saline Pain Pump , Injectable Medication | Pain Score 8 Hours Post-operativley | 1.8 units on a scale | Standard Deviation 0.3282 |
| Injectable Medication Only | Pain Score 8 Hours Post-operativley | 1.06 units on a scale | Standard Deviation 0.3282 |
Secondary
Number of Narcotic Pills and Morphine Sulfate Used
Time frame: Post surgery day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pain Pump , Injectable Medication | Number of Narcotic Pills and Morphine Sulfate Used | 2.1 number of pills | Standard Deviation 0.16 |
| Saline Pain Pump , Injectable Medication | Number of Narcotic Pills and Morphine Sulfate Used | 2.7 number of pills | Standard Deviation 0.16 |
| Injectable Medication Only | Number of Narcotic Pills and Morphine Sulfate Used | 1.7 number of pills | Standard Deviation 0.16 |
Secondary
Number of Narcotic Pills and Morphine Sulfate Used
Pill count
Time frame: In recovery room
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pain Pump , Injectable Medication | Number of Narcotic Pills and Morphine Sulfate Used | 2.2 Pills | Standard Deviation 0.61 |
| Saline Pain Pump , Injectable Medication | Number of Narcotic Pills and Morphine Sulfate Used | 1.8 Pills | Standard Deviation 0.61 |
| Injectable Medication Only | Number of Narcotic Pills and Morphine Sulfate Used | 1.3 Pills | Standard Deviation 0.61 |
Secondary
Number of Narcotic Pills and Morphine Sulfate Used
Pill Count
Time frame: Post surgery day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pain Pump , Injectable Medication | Number of Narcotic Pills and Morphine Sulfate Used | 3.41 Number of pills | Standard Deviation 0.87 |
| Saline Pain Pump , Injectable Medication | Number of Narcotic Pills and Morphine Sulfate Used | 3.8 Number of pills | Standard Deviation 0.87 |
| Injectable Medication Only | Number of Narcotic Pills and Morphine Sulfate Used | 3.8 Number of pills | Standard Deviation 0.87 |
Secondary
Number of Narcotic Pills and Morphine Sulfate Used
Time frame: Post surgery day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pain Pump , Injectable Medication | Number of Narcotic Pills and Morphine Sulfate Used | 1.1 Number of pills | Standard Deviation 0.08 |
| Saline Pain Pump , Injectable Medication | Number of Narcotic Pills and Morphine Sulfate Used | 1.5 Number of pills | Standard Deviation 0.08 |
| Injectable Medication Only | Number of Narcotic Pills and Morphine Sulfate Used | 0.8 Number of pills | Standard Deviation 0.08 |