PROPER Trial of Pain and Inflammation After Knee Arthroscopy

Study Overview
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Brief Summary
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The purpose of this study is to determine if ceftriaxone administered postoperatively via intravenous injection reduces postoperative visual analog scale (VAS) pain scores and narcotic consumption in patients undergoing knee arthroscopy for a cartilage or meniscal injury.

Detailed Description
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Arthroscopic surgery for cartilage and meniscus injuries are some of the most common orthopaedic procedures currently performed. Post-surgical pain is initiated through an inflammatory response to surgery. The pain response leads to sleep disruption and a further increase in pain and additional sleep disruption. Opioid medications are often used after surgery to treat pain despite the side effect profile. These medications also contribute to poor sleep quality and duration. Early pain and narcotic use can be controlled by mitigating the effects of post-surgical inflammation. Ceftriaxone is a readily available antibiotic and may have the desirable anti-inflammatory and analgesic effects, but without the side effects caused by other medications. Since it is highly selective in its inhibition, ceftriaxone is an excellent candidate for reducing immediate post-operative pain and heightened inflammatory response. By doing this study, the investigators hope to learn about the anti-inflammatory effectiveness of the antibiotic ceftriaxone. Ceftriaxone has been shown to inhibit a key enzyme in the post-operative inflammatory process and has been safely used for treatment of infections for years. The investigators would like to gather information about whether ceftriaxone helps reduce pain and inflammation after surgery. Participation in this research will last about 2 months.

Official Title
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Early Reduction of Post-opeRative Pain and Inflammation to Expedite Return to Function After KNEE Arthroscopy

Conditions
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Meniscus Tear, Meniscus Lesion, Cartilage Injury

Intervention / Treatment
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* Drug: Ceftriaxone
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written consent to participate in the study Male or female greater than or equal to 18 years of age and less than 55 years of age Is indicated for knee arthroscopy for cartilage or meniscal procedure Ambulatory and in good general health Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions. Willing to abstain from use of protocol-restricted medications during the study Exclusion Criteria: Known allergic reactions to cephalosporins Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease History of infection in either knee joint Clinical signs and symptoms of active knee infection or crystal disease in either knee within 1 month of Screening Other surgery or arthroscopy of either knee within 6 months of Screening Intraarticular treatment of any joint with any of the following agents within six (6) months of Screening: any corticosteroid preparation or any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection; investigational or marketed). Intraarticular treatment in either knee with hyaluronic acid (investigational or marketed) within 6 months of Screening Parenteral or oral corticosteroids (investigational or marketed) within 3 months of Screening Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening Females who are pregnant or nursing or plan to become pregnant during the study; men whose female partner plans to conceive during the study Radiographic osteoarthritic changes defined as Kellgren-Lawrence grade 2 or greater (as determined by PI from patient's preoperative X-rays) Inability to read and understand English Any prior diagnosis of antibiotic-resistant diarrhea

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: After providing informed consent, patients undergoing arthroscopy of the knee for meniscal or cartilage injuries will be randomized into one of two groups. At the time of surgery, while the patient is under anesthesia, one group will receive a single intravenous dose of 1 gram of ceftriaxone and the other will receive a single intravenous dose of 1% lidocaine in saline.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>The experimental group will receive a single intravenous dose of 1 g of ceftriaxone immediately postoperative in the operating room. | Drug: Ceftriaxone<br>* single intravenous dose of 1 g of ceftriaxone<br>|
| Placebo Comparator: Placebo<br>The placebo group will receive a single intravenous dose of 1% lidocaine and saline immediately postoperative in the operating room. | Other: Placebo<br>* 1% lidocaine and saline<br>* Other names: Lidocaine and Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Scale (VAS) Pain Score | The Visual analog scale scores range from 0 to 10 with greater scores indicative of greater pain. | Pre-operative, 2 months post-operative | 
| Change in RU SATED Score | The Regularity, Sleep Quality, Alertness, Timing, Efficiency, Duration scale for sleep (RU SATED) ranges from 0 to 30, with higher scores indicating better sleep health. | Pre-operative, 2 months post-operative | 
| Post-operative Narcotic Use | Post-operative narcotic use will be monitored with self-reported medication consumption at the first post-operative visit, which will take place 5-12 days post-operative. The milligrams of morphine equivalent (MME) will be calculated based on patient responses with greater MME indicative of increased postoperative use of narcotic pain medications. | 5-12 days post-operative |