Cartilage Injury, Meniscus Lesion, Meniscus Tear
Conditions
Brief summary
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
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.
Interventions
DRUGCeftriaxone
single intravenous dose of 1 g of ceftriaxone
OTHERPlacebo
1% lidocaine and saline
Sponsors
Austin V Stone
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
One group will receive an intravenous dose of ceftriaxone and the other will receive an intravenous dose of lidocaine in saline. The syringes will be blinded to ensure that both the investigator administering the injection and the patient will be blinded to the group assignment.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Written consent to participate in the study 2. Male or female greater than or equal to 18 years of age and less than 55 years of age 3. Is indicated for knee arthroscopy for cartilage or meniscal procedure 4. Ambulatory and in good general health 5. Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions. 6. Willing to abstain from use of protocol-restricted medications during the study
Exclusion criteria
1. Known allergic reactions to cephalosporins 2. Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease 3. History of infection in either knee joint 4. Clinical signs and symptoms of active knee infection or crystal disease in either knee within 1 month of Screening 5. Other surgery or arthroscopy of either knee within 6 months of Screening 6. 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). 7. Intraarticular treatment in either knee with hyaluronic acid (investigational or marketed) within 6 months of Screening 8. Parenteral or oral corticosteroids (investigational or marketed) within 3 months of Screening 9. Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening 10. Females who are pregnant or nursing or plan to become pregnant during the study; men whose female partner plans to conceive during the study 11. Radiographic osteoarthritic changes defined as Kellgren-Lawrence grade 2 or greater (as determined by PI from patient's preoperative X-rays) 12. Inability to read and understand English 13. Any prior diagnosis of antibiotic-resistant diarrhea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog Scale (VAS) Pain Score | Pre-operative, 2 months post-operative | The Visual analog scale scores range from 0 to 10 with greater scores indicative of greater pain. |
| Change in RU SATED Score | Pre-operative, 2 months post-operative | 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. |
| Post-operative Narcotic Use | 5-12 days post-operative | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental The experimental group will receive a single intravenous dose of 1 g of ceftriaxone immediately postoperative in the operating room.
Ceftriaxone: single intravenous dose of 1 g of ceftriaxone | 3 |
| Placebo The placebo group will receive a single intravenous dose of 1% lidocaine and saline immediately postoperative in the operating room.
Placebo: 1% lidocaine and saline | 2 |
| Total | 5 |
Baseline characteristics
| Characteristic | Placebo | Total | Experimental |
|---|---|---|---|
| Age, Continuous | 45.5 years STANDARD_DEVIATION 9.1 | 43.8 years STANDARD_DEVIATION 4.9 | 42.7 years STANDARD_DEVIATION 1.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 4 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 2 |
| other Total, other adverse events | 0 / 3 | 0 / 2 |
| serious Total, serious adverse events | 0 / 3 | 0 / 2 |
Outcome results
Primary
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.
Time frame: Pre-operative, 2 months post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Change in RU SATED Score | 1 units on a scale | Standard Deviation 0 |
| Placebo | Change in RU SATED Score | -0.5 units on a scale | Standard Deviation 2.1 |
Primary
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.
Time frame: Pre-operative, 2 months post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Change in Visual Analog Scale (VAS) Pain Score | -2.67 units on a scale | Standard Deviation 1.11 |
| Placebo | Change in Visual Analog Scale (VAS) Pain Score | -2.1 units on a scale | Standard Deviation 2.97 |
Primary
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.
Time frame: 5-12 days post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Post-operative Narcotic Use | 15 milligrams of morphine equivalent (MME) | Standard Deviation 4.4 |
| Placebo | Post-operative Narcotic Use | 5.5 milligrams of morphine equivalent (MME) | Standard Deviation 2.1 |