Anesthésique optimal pour les injections de corticostéroïdes pour l'arthrose du genou (Injections)
Anesthésique optimal pour les injections de corticostéroïdes pour l'arthrose du genou.
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).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Florida
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Tampa, Florida, États-Unis, 33637
- Florida Orthopaedic Institute
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
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Expérimental: 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.
Autres noms:
|
|
Expérimental: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Injection for Knee Pain
Délai: Prior to procedure (in office)
|
Visual Analogue Scale (VAS) |
Prior to procedure (in office)
|
|
Injection for Knee Pain
Délai: Immediate post procedure (in office)
|
Visual Analogue Scale (VAS) |
Immediate post procedure (in office)
|
|
Injection for Knee Pain
Délai: 2 minutes post procedure (in office)
|
Visual Analogue Scale (VAS) |
2 minutes post procedure (in office)
|
|
Injection for Knee Pain
Délai: Day 1 post procedure (phone interview)
|
Visual Analogue Scale (VAS) |
Day 1 post procedure (phone interview)
|
|
Injection for Knee Pain
Délai: Day 14 post procedure (through EDC)
|
Visual Analogue Scale (VAS) |
Day 14 post procedure (through EDC)
|
|
Injection for Knee Pain
Délai: Day 42 post procedure (in office)
|
Visual Analogue Scale (VAS) |
Day 42 post procedure (in office)
|
|
Injection for Knee Pain
Délai: Day 84 post procedure (through EDC)
|
Visual Analogue Scale (VAS) |
Day 84 post procedure (through EDC)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Assessment of Knee Pain
Délai: Immediate Post-op (in office)
|
Global Perceived Improvement |
Immediate Post-op (in office)
|
|
Assessment of Knee Pain
Délai: Day 1 post procedure (phone interview)
|
Global Perceived Improvement |
Day 1 post procedure (phone interview)
|
|
Assessment of Knee Pain
Délai: Day 42 post procedure (in office)
|
Global Perceived Improvement |
Day 42 post procedure (in office)
|
|
Assessment of Knee Pain
Délai: Day 84 post procedure (through EDC)
|
Global Perceived Improvement |
Day 84 post procedure (through EDC)
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Medications
Délai: Prior to procedure (in office)
|
Review of Medications |
Prior to procedure (in office)
|
|
Medications
Délai: Day 1 post procedure (phone interview)
|
Review of Medications |
Day 1 post procedure (phone interview)
|
|
Medications
Délai: Day 14 post procedure (through EDC)
|
Review of Medications |
Day 14 post procedure (through EDC)
|
|
Medications
Délai: Day 42 post procedure (in office)
|
Review of Medications |
Day 42 post procedure (in office)
|
|
Medications
Délai: Day 84 post procedure (through EDC)
|
Review of Medications |
Day 84 post procedure (through EDC)
|
|
Review of Adverse Events
Délai: Immediate post procedure (in office)
|
Any issues with procedure |
Immediate post procedure (in office)
|
|
Review of Adverse Events
Délai: Day 1 post procedure (phone interview)
|
Any issues with procedure |
Day 1 post procedure (phone interview)
|
|
Review of Adverse Events
Délai: Day 42 post procedure (in office)
|
Any issues with procedure |
Day 42 post procedure (in office)
|
|
Review of Adverse Events
Délai: Day 84 post procedure (through EDC)
|
Any issues with procedure |
Day 84 post procedure (through EDC)
|
Collaborateurs et enquêteurs
Collaborateurs
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies musculo-squelettiques
- Arthrite
- Maladies articulaires
- Maladies rhumatismales
- Arthrose
- Arthrose, Genou
- Hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Produits chimiques organiques
- Composés polycycliques
- Anilides
- Amides
- Composés aniline
- Amines
- Triamcinolone
- Prégnades
- Grossesse
- Stéroïdes
- Composés à anneau fusionné
- Stéroïdes, fluorés
- Bupivacaïne
- Acétonide de triamcinolone
- Hormones cortex surrénaliques
Autres numéros d'identification d'étude
- PI_ PAL_V3_ 8
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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