PROPER Trial of Pain and Inflammation After Knee Arthroscopy

NCT ID: NCT05149287

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-28
• Study Completion Date: 2022-04-29

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.

Conditions

Meniscus Tear; Meniscus Lesion; Cartilage Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental

The experimental group will receive a single intravenous dose of 1 g of ceftriaxone immediately postoperative in the operating room.

Group Type: EXPERIMENTAL

Ceftriaxone

Intervention Type: DRUG

single intravenous dose of 1 g of ceftriaxone

Placebo

The placebo group will receive a single intravenous dose of 1% lidocaine and saline immediately postoperative in the operating room.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

1% lidocaine and saline

Interventions

Ceftriaxone

single intravenous dose of 1 g of ceftriaxone

Intervention Type: DRUG

Placebo

1% lidocaine and saline

Intervention Type: OTHER

Other Intervention Names

Lidocaine and Saline

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Austin V Stone

OTHER

Sponsor Role: lead

Responsible Party

Austin V Stone

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Austin V Stone, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

63476

Identifier Type: -

Identifier Source: org_study_id