Anestetico ottimale per iniezioni di corticosteroidi per l'artrosi del ginocchio (Injections)
Anestetico ottimale per iniezioni di corticosteroidi per l'artrosi del ginocchio.
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).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Florida
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Tampa, Florida, Stati Uniti, 33637
- Florida Orthopaedic Institute
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Kenalog with 0ml bupivacaine
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. |
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.
Altri nomi:
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Sperimentale: Kenalog with 4ml bupivacaine
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. |
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.
Altri nomi:
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Sperimentale: Kenalog with 0.25% bupivacaine
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. |
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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Injection for Knee Pain
Lasso di tempo: Prior to procedure (in office)
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Visual Analogue Scale (VAS) |
Prior to procedure (in office)
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Injection for Knee Pain
Lasso di tempo: Immediate post procedure (in office)
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Visual Analogue Scale (VAS) |
Immediate post procedure (in office)
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Injection for Knee Pain
Lasso di tempo: 2 minutes post procedure (in office)
|
Visual Analogue Scale (VAS) |
2 minutes post procedure (in office)
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Injection for Knee Pain
Lasso di tempo: Day 1 post procedure (phone interview)
|
Visual Analogue Scale (VAS) |
Day 1 post procedure (phone interview)
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Injection for Knee Pain
Lasso di tempo: Day 14 post procedure (through EDC)
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Visual Analogue Scale (VAS) |
Day 14 post procedure (through EDC)
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Injection for Knee Pain
Lasso di tempo: Day 42 post procedure (in office)
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Visual Analogue Scale (VAS) |
Day 42 post procedure (in office)
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Injection for Knee Pain
Lasso di tempo: Day 84 post procedure (through EDC)
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Visual Analogue Scale (VAS) |
Day 84 post procedure (through EDC)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Assessment of Knee Pain
Lasso di tempo: Immediate Post-op (in office)
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Global Perceived Improvement |
Immediate Post-op (in office)
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Assessment of Knee Pain
Lasso di tempo: Day 1 post procedure (phone interview)
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Global Perceived Improvement |
Day 1 post procedure (phone interview)
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Assessment of Knee Pain
Lasso di tempo: Day 42 post procedure (in office)
|
Global Perceived Improvement |
Day 42 post procedure (in office)
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Assessment of Knee Pain
Lasso di tempo: Day 84 post procedure (through EDC)
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Global Perceived Improvement |
Day 84 post procedure (through EDC)
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Medications
Lasso di tempo: Prior to procedure (in office)
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Review of Medications |
Prior to procedure (in office)
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Medications
Lasso di tempo: Day 1 post procedure (phone interview)
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Review of Medications |
Day 1 post procedure (phone interview)
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Medications
Lasso di tempo: Day 14 post procedure (through EDC)
|
Review of Medications |
Day 14 post procedure (through EDC)
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Medications
Lasso di tempo: Day 42 post procedure (in office)
|
Review of Medications |
Day 42 post procedure (in office)
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Medications
Lasso di tempo: Day 84 post procedure (through EDC)
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Review of Medications |
Day 84 post procedure (through EDC)
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Review of Adverse Events
Lasso di tempo: Immediate post procedure (in office)
|
Any issues with procedure |
Immediate post procedure (in office)
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Review of Adverse Events
Lasso di tempo: Day 1 post procedure (phone interview)
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Any issues with procedure |
Day 1 post procedure (phone interview)
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Review of Adverse Events
Lasso di tempo: Day 42 post procedure (in office)
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Any issues with procedure |
Day 42 post procedure (in office)
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Review of Adverse Events
Lasso di tempo: Day 84 post procedure (through EDC)
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Any issues with procedure |
Day 84 post procedure (through EDC)
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Collaboratori e investigatori
Collaboratori
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
- 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.
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie muscoloscheletriche
- Artrite
- Malattie articolari
- Malattie reumatiche
- Osteoartrite
- Artrosi, ginocchio
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Prodotti chimici organici
- Composti policiclici
- Anilides
- Amides
- Composti di anilina
- Ammine
- Triamcinolone
- Incinta
- In gravidanza
- Steroidi
- Composti anelli fusi
- Steroidi, fluorurati
- Bupivacaina
- Triamcinolone acetonide
- Ormoni della corteccia surrenale
Altri numeri di identificazione dello studio
- PI_ PAL_V3_ 8
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