Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis

Официальное название

Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis.

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат Kenalog with bupivacaine Injection
  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.

Первичные конечные точки

• Injection for Knee Pain [Срок оценки: Prior to procedure (in office)]
• Injection for Knee Pain [Срок оценки: Immediate post procedure (in office)]
• Injection for Knee Pain [Срок оценки: 2 minutes post procedure (in office)]
• Injection for Knee Pain [Срок оценки: Day 1 post procedure (phone interview)]
• Injection for Knee Pain [Срок оценки: Day 14 post procedure (through EDC)]
• Injection for Knee Pain [Срок оценки: Day 42 post procedure (in office)]
• Injection for Knee Pain [Срок оценки: Day 84 post procedure (through EDC)]

Вторичные конечные точки (4)

• Assessment of Knee Pain [Срок оценки: Immediate Post-op (in office)]
• Assessment of Knee Pain [Срок оценки: Day 1 post procedure (phone interview)]
• Assessment of Knee Pain [Срок оценки: Day 42 post procedure (in office)]
• Assessment of Knee Pain [Срок оценки: Day 84 post procedure (through EDC)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Florida Orthopaedic Institute — Tampa

Публикации

• 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. PMID 29079170
• 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. PMID 33616067
• 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. PMID 20194319
• 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. PMID 12867587
• 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. PMID 17244900

Идентификаторы

NCT: NCT05906433 · PI_ PAL_V3_ 8

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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