Comparison of a Pain Pump Versus Injectable Medication for Analgesia in Knee Arthroscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of a Pain Pump Versus Injectable Medication for Analgesia in Knee Arthroscopy

Conditions
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Pain

Intervention / Treatment
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* Device: pain pump containing ropivacaine
* Device: saline pain pump with injectable medication
* Drug: ropivacaine, ketorolac , morphine sulfate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pain pump , injectable medication<br>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; | Device: pain pump containing ropivacaine<br>* 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<br>* Other names: pump;|
| Active Comparator: saline pain pump , injectable medication<br>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 | Device: saline pain pump with injectable medication<br>* 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<br>* Other names: saline;|
| Active Comparator: injectable medication only<br>30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump. | Drug: ropivacaine, ketorolac , morphine sulfate<br>* 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected<br>* Other names: sulfate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |