Corticosteroid + Anesthetic Injection for Knee Osteoarthritis

(Injections Trial)

Overseen By Debbi Warren, RN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Foundation for Orthopaedic Research and Education

Must not be taking: Narcotics

Disqualifiers: Inflammatory arthritis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

75 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have been using narcotics in the past 6 months, you cannot participate.

What data supports the effectiveness of the drug Kenalog with bupivacaine Injection for knee osteoarthritis?

Research shows that injecting triamcinolone, a component of Kenalog, into the knee can significantly reduce pain and improve function in people with knee osteoarthritis for up to six weeks. This suggests that Kenalog, when combined with bupivacaine, may also be effective in managing knee osteoarthritis symptoms. ^{1 2 3 4 5}

Is the combination of corticosteroid and anesthetic injection generally safe for humans?

The combination of triamcinolone acetonide (a corticosteroid) and anesthetics like bupivacaine has been used in various treatments, but it can have side effects. Some reported side effects include weight gain, changes in menstruation, increased blood pressure, and rare allergic reactions. It's important to discuss potential risks with a healthcare provider. ^{6 7 8 9 10}

How is the drug Kenalog with bupivacaine injection unique for knee osteoarthritis?

Kenalog with bupivacaine injection combines a corticosteroid (triamcinolone acetonide) with a local anesthetic (bupivacaine) to provide both immediate pain relief and longer-term reduction of inflammation in knee osteoarthritis, which is different from using corticosteroids alone. ^{1 2 3 9 11}

What is the purpose of this trial?

To evaluate pain relief from corticosteroid injection with and without anesthetic as well as with variable volume of anesthetic. Pain relief will be measured using the VAS pain score at the time of the injection as well as several time points following the injection to capture pain relief longevity. The investigators intend to evaluate how well the patients tolerate corticosteroid mixtures without anesthetic as well as with different volumes of anesthetic. Primary measure will be the time from procedure when postoperative status is considered success (as measured by global perceived improvement score).

Eligibility Criteria

This trial is for adults over 18 with moderate osteoarthritis (Kellgren Lawrence Stage II or III) who can give consent. It's not suitable for those outside this group.

Inclusion Criteria

My arthritis is moderate to severe.

I have been diagnosed with primary osteoarthritis.

Exclusion Criteria

I have a type of arthritis that causes joint inflammation.

History of narcotic use for the past 6 months

My arthritis is either mild or very severe.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one intra-articular knee injection of synthetic corticosteroid (Kenalog) with variable amounts of anesthetic

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain relief and adverse events using the VAS pain score and other assessments

12 weeks

Multiple assessments (virtual or in-person)

Treatment Details

Interventions

• Kenalog with bupivacaine Injection

Trial Overview The study tests pain relief from corticosteroid injections, both with and without anesthetic, in knee osteoarthritis patients. Pain levels are tracked over time to see how long relief lasts and how well different mixtures work.

Participant Groups

Group I: Kenalog with 4ml bupivacaine Experimental Treatment 1 Intervention

The intervention in this study is one intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic,4ml of bupivacaine. The patients will be randomized into this group.

Group II: Kenalog with 0ml bupivacaine Experimental Treatment 1 Intervention

The intervention in this study is one intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic,0ml of bupivacaine. The patients will be randomized into this group.

Group III: Kenalog with 0.25% bupivacaine Experimental Treatment 1 Intervention

The intervention in this study is one intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic,0.25% of bupivacaine. The patients will be randomized into this group.

Kenalog with bupivacaine Injection is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Kenalog for:

• Osteoarthritis
• Rheumatoid arthritis
• Bursitis
• Tendinitis
• Gouty arthritis

Approved in European Union as Kenalog for:

• Rheumatoid arthritis
• Osteoarthritis
• Bursitis
• Tendinitis
• Gouty arthritis

Approved in Canada as Kenalog for:

• Rheumatoid arthritis
• Osteoarthritis
• Bursitis
• Tendinitis
• Gouty arthritis

Who Is Running the Clinical Trial?

Foundation for Orthopaedic Research and Education

Lead Sponsor

Trials

16

Recruited

1,000+

Florida Orthopaedic Institute

Collaborator

Trials

9

Recruited

480+

Findings from Research

In a study involving 100 patients with knee osteoarthritis, both triamcinolone hexacetonide (TH) and methylprednisolone acetate (MA) injections significantly reduced pain at 4 weeks, with sustained improvements observed up to 24 weeks.

There was no significant difference in efficacy between TH and MA, as both treatments showed similar outcomes in pain relief and functional improvement, indicating that either corticosteroid can be effectively used for managing knee OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Triamcinolone Hexacetonide versus Methylprednisolone Acetate Intraarticular Injections in Knee Osteoarthritis: A Randomized, Double-blinded, 24-week Study. Lomonte, AB., de Morais, MG., de Carvalho, LO., et al.[2022]

In a randomized double-blind placebo-controlled trial involving 117 patients with knee osteoarthritis, Triamcinolone acetenoid injections provided significant pain relief at two and six weeks, with effects lasting up to twelve weeks, compared to placebo.

The study demonstrated that Triamcinolone not only alleviated pain but also significantly improved functional outcomes in patients, with no major complications reported, indicating it is a safe and effective treatment option for knee osteoarthritis in community health settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcome following Intra-articular Triamcinolone Injection in Osteoarthritic Knee at the Community: A Randomized Double Blind Placebo Controlled Trial. [2019]

In a study involving 84 patients with symptomatic knee osteoarthritis, a 10-mg dose of triamcinolone acetonide was found to be non-inferior to a 40-mg dose in reducing pain after 12 weeks, indicating that lower doses can be just as effective.

Both the 10-mg and 40-mg doses significantly improved pain and quality of life for patients, suggesting that lower doses may provide a safer option without compromising efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of intra-articular triamcinolone acetonide 10 mg vs. 40 mg in patients with knee osteoarthritis: a non-inferiority, randomized, controlled, double-blind, multicenter study. Utamawatin, K., Phruetthiphat, OA., Apinyankul, R., et al.[2023]

In a randomized controlled trial involving 84 patients undergoing total knee arthroplasty (TKA), the addition of either high or low doses of corticosteroids to local anesthetic injections did not significantly reduce post-operative pain or improve range of motion.

The study suggests that peri-articular corticosteroids do not provide additional benefits in managing pain or recovery after TKA for patients with osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peri-articular steroid injection in total knee arthroplasty: a prospective, double blinded, randomized controlled trial. Chia, SK., Wernecke, GC., Harris, IA., et al.[2022]

Intraarticular triamcinolone acetonide significantly reduced acute pain after arthroscopic knee surgery, with lower pain scores observed from 6 to 24 hours post-surgery compared to the saline control group.

Patients receiving triamcinolone required significantly less rescue analgesia, with none requesting additional pain relief compared to 53% in the saline group, highlighting its efficacy as a local pain management option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraarticular triamcinolone acetonide for pain control after arthroscopic knee surgery. Wang, JJ., Ho, ST., Lee, SC., et al.[2022]

In a study of 145 patients with severe bronchial asthma, repeated intramuscular injections of triamcinolone acetonide (Kenalog) resulted in excellent or good outcomes in 88.3% of cases, indicating its high efficacy for patients who did not respond to other treatments.

While Kenalog was effective, 13.8% of patients experienced side effects such as weight gain and increased blood pressure, highlighting the need for careful monitoring during prolonged steroid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. Romański, B., Pawlik, K., Wilewska-Klubo, T.[2013]

In a study of 81 patients receiving intravitreal Kenalog injections, 12.3% developed presumed sterile endophthalmitis, indicating a significant risk associated with this treatment.

While all cases of inflammation resolved with treatment, two patients experienced serious complications that led to a loss of best corrected visual acuity, highlighting the potential for severe outcomes despite the generally benign nature of sterile endophthalmitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Presumed Sterile Endophthalmitis Afer Intravitreal Triamcinolone (Kenalog)-More Common and Less Benign Than We Thought? Fong, AH., Chan, CK.[2017]

In a study involving 30 children with non-infectious uveitis, subtenon triamcinolone acetonide (STA) injections showed significant efficacy, with 85.4% of eyes experiencing inflammation improvement and 77.8% resolution of macular edema at the 3-month follow-up.

The procedure was safe, with no immediate complications reported, and only a 12.5% incidence of ocular hypertension at 6 months, indicating that STA injections are a well-tolerated treatment option for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subtenon Triamcinolone Acetonide Injection with Topical Anesthesia in Pediatric Non-Infectious Uveitis. Jung, JL., Harasawa, M., Patnaik, JL., et al.[2023]

The study found that combining 1% lidocaine or 0.25% bupivacaine with betamethasone sodium phosphate or betamethasone acetate significantly increased chondrotoxicity in human chondrocytes after 14 days, indicating potential harm to joint cartilage.

Methylprednisolone acetate and triamcinolone acetonide also showed significant chondrotoxic effects when used with 1% lidocaine, but not with 0.25% bupivacaine, suggesting that the choice of local anesthetic can influence the safety of corticosteroid injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of local anesthetic and corticosteroid combinations on chondrocyte viability. Braun, HJ., Wilcox-Fogel, N., Kim, HJ., et al.[2021]

A 24-year-old woman experienced an immediate hypersensitivity reaction to intralesional triamcinolone acetonide after 10 years of successful treatment for keloid scars, highlighting that such reactions, while uncommon, can occur even after multiple prior injections without issues.

Allergy testing confirmed a positive reaction specifically to triamcinolone acetonide, indicating that IgE-mediated hypersensitivity should be considered in patients receiving repeated injections of this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaphylaxis following intralesional triamcinolone acetonide (Kenacort) injection. Laisuan, W., Wongsa, C., Dchapaphapeaktak, N., et al.[2020]

The study found that combining local anesthetics (lidocaine, ropivacaine, and bupivacaine) with the novel triamcinolone acetonide extended-release (TA-ER) formulation does not negatively affect its physical or chemical properties, ensuring its efficacy remains intact.

This compatibility suggests that in clinical practice, local anesthetics can be safely added to TA-ER injections for knee osteoarthritis pain without compromising the treatment's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical and Chemical Compatibility of Extended-Release Triamcinolone Acetonide (TA-ER) with Common Local Anesthetics. Jackson, JD., Cotton, L., Turkington, M., et al.[2020]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Efficacy of Triamcinolone Hexacetonide versus Methylprednisolone Acetate Intraarticular Injections in Knee Osteoarthritis: A Randomized, Double-blinded, 24-week Study. [2022]

2. Nepal pubmed.ncbi.nlm.nih.gov

Clinical Outcome following Intra-articular Triamcinolone Injection in Osteoarthritic Knee at the Community: A Randomized Double Blind Placebo Controlled Trial. [2019]

3. England pubmed.ncbi.nlm.nih.gov

The efficacy of intra-articular triamcinolone acetonide 10 mg vs. 40 mg in patients with knee osteoarthritis: a non-inferiority, randomized, controlled, double-blind, multicenter study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Peri-articular steroid injection in total knee arthroplasty: a prospective, double blinded, randomized controlled trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Intraarticular triamcinolone acetonide for pain control after arthroscopic knee surgery. [2022]

6. Singapore pubmed.ncbi.nlm.nih.gov

The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. [2013]

7. China pubmed.ncbi.nlm.nih.gov

Presumed Sterile Endophthalmitis Afer Intravitreal Triamcinolone (Kenalog)-More Common and Less Benign Than We Thought? [2017]

8. England pubmed.ncbi.nlm.nih.gov

Subtenon Triamcinolone Acetonide Injection with Topical Anesthesia in Pediatric Non-Infectious Uveitis. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

The effect of local anesthetic and corticosteroid combinations on chondrocyte viability. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Anaphylaxis following intralesional triamcinolone acetonide (Kenacort) injection. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Physical and Chemical Compatibility of Extended-Release Triamcinolone Acetonide (TA-ER) with Common Local Anesthetics. [2020]