The Effect of RF Genicular Nerve Block Applied in the Preoperative Period on Fast-track Total Knee Arthroplasty

Обзор

In our study, investigators plan to compare the preoperative RF and genicular nerve ablation approach in patients who underwent TKA(Total Knee Arthroplasty) using the Fast-Track protocol in terms of meeting postoperative pain, function and early discharge criteria.

Подробное описание

One of the most important components of surgery using Fast-Track is the application of effective and well-monitored pain treatment. Post-surgical pain negatively affects the patient's early mobilization. Reduction in pain after TKA(Total Knee Arthroplasty) may not only increase short-term functional results but also increase the patient's overall satisfaction.

Genicular Nerve Radiofrequency Ablation (GNRFA) is a non-surgical treatment increasingly used in patients with advanced knee osteoarthritis. Previous studies have shown this to be an effective and safe method to reduce pain and improve functionality in this patient population.

Neurolysis of genicular nerves with radiofrequency (RF) may be useful to relieve pain and improve both function and quality of life in patients with post-TKA pain.

Investigators thought that reducing the pain of patients who underwent TKA with Fast-track in the postoperative period would contribute to early mobilization and therefore rapid functional recovery. As a result of previous studies, investigators know that genicular nerve neurolysis with RF Ablation in the preoperative period provides a reduction in postoperative pain.

Investigators routinely apply TKA applications in clinic with Fast-Track. In investigators hospital's algology outpatient clinic, genicular nerve RF ablation is routinely performed under USG or fluoroscopy guidance. In investigators study, investigators plan to compare the preoperative RF and genicular nerve ablation approach in patients who underwent TKA using the Fast-Track protocol in terms of meeting postoperative pain, function and early discharge criteria

Вмешательства

• Процедура Genicular nerve Radiofrequency Ablation block
  Genicular nerve Radiofrequency Ablation block

Первичные конечные точки

• Pain preoperative [Срок оценки: Baseline (preoperatively)]
• Pain postoperative 1 [Срок оценки: at postoperative sixth weeks]
• Pain postoperative 2 [Срок оценки: at postoperative twelfth weeks]
• Knee Range of Motion preoperative [Срок оценки: Baseline (preoperatively)]
• Knee Range of Motion postoperative 1 [Срок оценки: at postoperative sixth week]
• Knee Range of Motion postoperative 2 [Срок оценки: at postoperative twelfth week]
• Quadriceps muscle strength preoperative [Срок оценки: Baseline (preoperatively)]
• Quadriceps muscle strength postoperative 1 [Срок оценки: at postoperative sixth weeks]
• Quadriceps muscle strength postoperative 2 [Срок оценки: at postoperative twelfth week]
• Patient-reported activity limitations preoperative [Срок оценки: Baseline (preoperatively)]

Вторичные конечные точки (3)

• Length of operation time [Срок оценки: the surgery]
• Amount of blood loss [Срок оценки: through study completion, an average of 1 year]
• postoperative component alignments [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• Being between the ages of 40 and 85,
• Being able to understand verbal and written information given in Turkish,
• Being able to speak and understand Turkish,
• Being subjected to unilateral TKA surgery due to the diagnosis of Primary Knee osteoarthritis

Критерии исключения

• Patients planned for revision knee prosthesis surgery,
• Patients previously diagnosed with psychiatric disorders,
• Patients who have undergone major surgery on the extremity where TKA will be applied,
• Patients with comorbid diseases such as rheumatoid arthritis or cancer,
• Patients with a score above 3 according to the American Society of Anesthesiologists (ASA) scoring,
• Patients with neurological diseases that cause functional disability,
• Patients with flexion limitation of more than 45 degrees and extension limitation of more than 20 degrees,
• Patients who have to use hypnotic or anxiolytic drugs regularly,
• Patients with alcohol or drug addiction,
• Patients with bleeding disorders
• Patients with uncontrolled diabetes

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр

• Pamukkale University — Denizli

Публикации

• Stake S, Agarwal AR, Coombs S, Cohen JS, Golladay GJ, Campbell JC, Thakkar SC. Total Knee Arthroplasty After Genicular Nerve Radiofrequency Ablation: Reduction in Prolonged Opioid Use Without Increased Postsurgical Complications. J Am Acad Orthop Surg Glob Res Rev. 2022 Aug 12;6(8):e22.00125. doi: 10.5435/JAAOSGlobal-D-22-00125. eCollection 2022 Aug 1. PMID 35960987
• Lloyd JM, Wainwright T, Middleton RG. What is the role of minimally invasive surgery in a fast track hip and knee replacement pathway? Ann R Coll Surg Engl. 2012 Apr;94(3):148-51. doi: 10.1308/003588412X13171221590214. PMID 22507716
• Sullivan M, Tanzer M, Reardon G, Amirault D, Dunbar M, Stanish W. The role of presurgical expectancies in predicting pain and function one year following total knee arthroplasty. Pain. 2011 Oct;152(10):2287-2293. doi: 10.1016/j.pain.2011.06.014. Epub 2011 Jul 18. PMID 21764515

Идентификаторы

NCT: NCT06239649 · 2023PAUOrto

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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