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| Name | Class |
|---|---|
| Florida Orthopaedic Institute | NETWORK |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kenalog with 0ml bupivacaine | Experimental | 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. |
|
| Kenalog with 4ml bupivacaine | Experimental | 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. |
|
| Kenalog with 0.25% bupivacaine | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kenalog with bupivacaine Injection | Drug | 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. |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Knee Pain | Global Perceived Improvement | Immediate Post-op (in office) |
| Assessment of Knee Pain | Global Perceived Improvement |
| Measure | Description | Time Frame |
|---|---|---|
| Medications | Review of Medications | Prior to procedure (in office) |
| Medications | Review of Medications | Day 1 post procedure (phone interview) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Meredith Baldy, CCRC | Contact | (813)978-9700 | ambaldy@foreonline.org | |
| Debbi Warren, RN | Contact | (813)978-9700 | dwarren@foreonline.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Orthopaedic Institute | Recruiting | Tampa | Florida | 33637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29079170 | Background | Bedard NA, Dowdle SB, Anthony CA, DeMik DE, McHugh MA, Bozic KJ, Callaghan JJ. Response to Letter to the Editor on "The AAHKS Clinical Research Award: What Are the Costs of Knee Osteoarthritis in the Year Prior to Total Knee Arthroplasty?". J Arthroplasty. 2018 Jan;33(1):307. doi: 10.1016/j.arth.2017.10.002. Epub 2017 Oct 10. No abstract available. | |
| 33616067 |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| D002045 | Bupivacaine |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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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).
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The PI standard of care is to offer patients who complain of knee pain a corticosteroids injection regardless of patient participation in a study. A consent will be obtained prior the injection by a trained/qualified team member. Subjects will be randomly allocated to groups by concealed allocation. Randomization sequence between three groups will be created using Excel and will be further stratified by sex within each block, to ensure even distribution. A set of numbered envelopes will be created, with each having one unique group assigned. A staff member will assign an envelope with group assignment upon consent and record envelope number ID. The ARNP will open an envelope, administer injection based on the group assigned. The ARNP will prepare the medication to maintain the double blinded aspect of the study. The ARNP is trained and experienced with injections and has giving injections for several years. She will not be involved in the evaluations of the patient pre/post injection.
|
|
| 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) |
| Medications | Review of Medications | Day 14 post procedure (through EDC) |
| Medications | Review of Medications | Day 42 post procedure (in office) |
| Medications | Review of Medications | Day 84 post procedure (through EDC) |
| Review of Adverse Events | Any issues with procedure | Immediate post procedure (in office) |
| Review of Adverse Events | Any issues with procedure | Day 1 post procedure (phone interview) |
| Review of Adverse Events | Any issues with procedure | Day 42 post procedure (in office) |
| Review of Adverse Events | Any issues with procedure | Day 84 post procedure (through EDC) |
| Blankstein M, Lentine B, Nelms NJ. Common Practices in Intra-Articular Corticosteroid Injection for the Treatment of Knee Osteoarthritis: A Survey of the American Association of Hip and Knee Surgeons Membership. J Arthroplasty. 2021 Mar;36(3):845-850. doi: 10.1016/j.arth.2020.09.022. Epub 2020 Oct 8. |
| 20194319 | Background | Grishko V, Xu M, Wilson G, Pearsall AW 4th. Apoptosis and mitochondrial dysfunction in human chondrocytes following exposure to lidocaine, bupivacaine, and ropivacaine. J Bone Joint Surg Am. 2010 Mar;92(3):609-18. doi: 10.2106/JBJS.H.01847. |
| 12867587 | Background | Smith MD, Wetherall M, Darby T, Esterman A, Slavotinek J, Roberts-Thomson P, Coleman M, Ahern MJ. A randomized placebo-controlled trial of arthroscopic lavage versus lavage plus intra-articular corticosteroids in the management of symptomatic osteoarthritis of the knee. Rheumatology (Oxford). 2003 Dec;42(12):1477-85. doi: 10.1093/rheumatology/keg398. Epub 2003 Jul 16. |
| 17244900 | Background | Parker RD, Streem K, Schmitz L, Martineau PA; Marguerite Group. Efficacy of continuous intra-articular bupivacaine infusion for postoperative analgesia after anterior cruciate ligament reconstruction: a double-blinded, placebo-controlled, prospective, and randomized study. Am J Sports Med. 2007 Apr;35(4):531-6. doi: 10.1177/0363546506296313. Epub 2007 Jan 23. |
| D012216 |
| Rheumatic Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |