A Phase 2 interventional study of Ceftriaxone and Placebo in Meniscus Tear, Meniscus Lesion and Cartilage Injury, sponsored by Austin V Stone. Terminated at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-05.
Sponsored by Austin V Stone · Phase 2, Interventional, and Treatment
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.
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.
Austin V Stone is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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The experimental group will receive a single intravenous dose of 1 g of ceftriaxone immediately postoperative in the operating room.
Drug: Ceftriaxone
The placebo group will receive a single intravenous dose of 1% lidocaine and saline immediately postoperative in the operating room.
Other: Placebo
single intravenous dose of 1 g of ceftriaxone
1% lidocaine and saline
Also known as: Lidocaine and Saline
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
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
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
| Milestone | Experimental | Placebo |
|---|---|---|
| Started | 3 | 2 |
| Completed | 3 | 2 |
| Not completed | 0 | 0 |
The Visual analog scale scores range from 0 to 10 with greater scores indicative of greater pain.
| units on a scale | Experimental | Placebo |
|---|---|---|
| Change in Visual Analog Scale (VAS) Pain Score | -2.67 ± 1.11 | -2.1 ± 2.97 |
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.
| units on a scale | Experimental | Placebo |
|---|---|---|
| Change in RU SATED Score | 1 ± 0 | -0.5 ± 2.1 |
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.
| milligrams of morphine equivalent (MME) | Experimental | Placebo |
|---|---|---|
| Post-operative Narcotic Use | 15 ± 4.4 | 5.5 ± 2.1 |
Collected over 2 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Placebo | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Continuous(years) | Experimental | Placebo | Total |
|---|---|---|---|
| Mean | 42.7 ± 1.5 | 45.5 ± 9.1 | 43.8 ± 4.9 |
| Sex: Female, Male(Participants) | Experimental | Placebo | Total |
|---|---|---|---|
| Female | 3 | 1 | 4 |
| Male | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Experimental | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 3 | 1 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Experimental | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 3 | 2 | 5 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — With the participant's approval and as approved by local Institutional Review Boards (IRBs), de-identified biological samples will be stored at the University of Kentucky Orthopedic Biomarker Repository. These samples could be used to research the causes of osteoarthritis after cartilage or meniscus injury, its complications and other conditions for which individuals with cartilage or meniscus injuries are at increased risk, and to improve treatment. Before sharing biomarker samples, we will ensure that the participant has given previous consent to the sharing of the information or samples. When we confirm that the previously provided consent is still in effect we will remove identifiers such as (e.g., name, medical record number, or date of birth). We will use a secure electronic log to track information shared without releasing the individual participant's identity.
Supporting information: Study protocol
Time frame: Access to individual participant data will be available 1 year after the final study follow-up has been completed, and will be available until 5 years after the final study follow-up has been completed.
Access criteria: The researchers requesting access to participant information or samples must complete a questionnaire describing why they need information or samples for their research and how they will use the information or samples. The researchers who receive the information or samples will sign an agreement to use the data responsibly.
Ran from Dec 2021 to primary completion in Apr 2022, 4 months.
Results were first posted in Sep 2023, 1 year 4 months after primary completion.
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This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ceftriaxone
Austin V Stone