Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis

Study Overview
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Brief Summary
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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).

Detailed Description
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Primary objective is to evaluate pain relief from corticosteroids, Kenalog without anesthetic as well as with different volumes of anesthetic. The investigators will measure the VAS pain score at the time of the injection as well as several time points following the injection. Additionally, the investigators will evaluate how long the injection provided pain relief for the patient. The secondary intend is to evaluate how well the patients tolerate Kenalog mixtures without anesthetic as well as with different volumes of anesthetic by using the VAS pain scale. The investigators hypothesize that patient with lower volume of injection will experience less pain during the procedure and that there will be no statistically significant difference in pain level between the study groups during the study period.

Official Title
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Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis.

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Drug: Kenalog with bupivacaine Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be 18 years of age and be able to consent for themselves. OA grade Kellgren Lawrence Stage II or III. Diagnosis of primary osteoarthritis. Exclusion Criteria: Patients with other forms of arthritis such as inflammatory arthritis. History of narcotic use for the past 6 months. Kellgren Lawrence arthritis grade 1 or 4. Pregnant women and prisoners.

Ages Eligible for Study
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Minimum Age: 18 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: At screening/baseline, informed consent will be obtained, demographics and medical history will be collected, patient x-ray will be reviewed/KL grade confirmed, narcotic use in last 6 months will be screened using E-FORCSE (Florida Prescription Drug Monitoring Program) database, inclusion and exclusion criteria will be assessed, and patient will be randomized into one of the study groups. We will only include patients who are receiving unilateral knee injections. Further, patient's baseline information on VAS Pain and current medication (analgesic or NSAID) will be collected. VAS Pain will be also collected immediately after the intervention and 2 minutes after the intervention, in addition to global perceived improvement score and AEs. The intervention in this study is intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic (0ml, 2ml or 4 ml of 0.25% bupivacaine).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kenalog with 0ml bupivacaine<br>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. | Drug: Kenalog with bupivacaine Injection<br>* Indications, relevant for this study include Kenalog injection for knee pain from osteoarthritis or inflammatory arthritis. A single injection to a patient who has no known allergies to anesthetic or corticosteroids would be administered during a scheduled clinical visit.<br>* Other names: Bupivacaine;|
| Experimental: Kenalog with 4ml bupivacaine<br>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. | Drug: Kenalog with bupivacaine Injection<br>* Indications, relevant for this study include Kenalog injection for knee pain from osteoarthritis or inflammatory arthritis. A single injection to a patient who has no known allergies to anesthetic or corticosteroids would be administered during a scheduled clinical visit.<br>* Other names: Bupivacaine;|
| Experimental: Kenalog with 0.25% bupivacaine<br>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. | Drug: Kenalog with bupivacaine Injection<br>* Indications, relevant for this study include Kenalog injection for knee pain from osteoarthritis or inflammatory arthritis. A single injection to a patient who has no known allergies to anesthetic or corticosteroids would be administered during a scheduled clinical visit.<br>* Other names: Bupivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injection for Knee Pain | Visual Analogue Scale (VAS) | Prior to procedure (in office) | 
| Injection for Knee Pain | Visual Analogue Scale (VAS) | Immediate post procedure (in office) | 
| Injection for Knee Pain | Visual Analogue Scale (VAS) | 2 minutes post procedure (in office) | 
| Injection for Knee Pain | Visual Analogue Scale (VAS) | Day 1 post procedure (phone interview) | 
| Injection for Knee Pain | Visual Analogue Scale (VAS) | Day 14 post procedure (through EDC) | 
| Injection for Knee Pain | Visual Analogue Scale (VAS) | Day 42 post procedure (in office) | 
| Injection for Knee Pain | Visual Analogue Scale (VAS) | Day 84 post procedure (through EDC) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Knee Pain | Global Perceived Improvement | Immediate Post-op (in office) | 
| Assessment of Knee Pain | Global Perceived Improvement | Day 1 post procedure (phone interview) | 
| Assessment of Knee Pain | Global Perceived Improvement | Day 42 post procedure (in office) | 
| Assessment of Knee Pain | Global Perceived Improvement | Day 84 post procedure (through EDC) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee injection, Knee osteoarthritis, corticosteroid