The Effect of RF Genicular Nerve Block Applied in the Preoperative Period on Fast-track Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Performance-based activity limitations-preoperative 1
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Performance-based activity limitations-preoperative 1
时间窗: at postoperative sixth weeks
30-sec chair-stand test and stair-climb test are used
Quality of life-preoperative
时间窗: Baseline (preoperatively)
Short Form-36 (SF-36) is used
Knee Range of Motion preoperative
时间窗: Baseline (preoperatively)
Digital goniometer used to assess knee range of motion
Performance-based activity limitations-preoperative 2
时间窗: at postoperative twelfth week
30-sec chair-stand test and stair-climb test are used
Pain preoperative
时间窗: Baseline (preoperatively)
Visual Analog Scale used to assess pain
Knee Range of Motion postoperative 2
时间窗: at postoperative twelfth week
Digital goniometer used to assess knee range of motion
Quadriceps muscle strength postoperative 2
时间窗: at postoperative twelfth week
Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer
Quality of life-preoperative 2
时间窗: at postoperative twelfth week
Short Form-36 (SF-36) is used
Length of hospital stay
时间窗: through study completion, an average of 1 year
Length of hospital stay is measured beginning from the hospitalization of the patient and ending at discharge of the patients (unit-hours)
Knee Range of Motion postoperative 1
时间窗: at postoperative sixth week
Digital goniometer used to assess knee range of motion
Quadriceps muscle strength postoperative 1
时间窗: at postoperative sixth weeks
Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer
Patient-reported activity limitations preoperative 2
时间窗: at postoperative twelfth week
The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used
Performance-based activity limitations-preoperative
时间窗: Baseline (preoperatively)
30-sec chair-stand test and stair-climb test are used
Pain postoperative 1
时间窗: at postoperative sixth weeks
Visual Analog Scale used to assess pain
Pain postoperative 2
时间窗: at postoperative twelfth weeks
Visual Analog Scale used to assess pain
Quadriceps muscle strength preoperative
时间窗: Baseline (preoperatively)
Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer
Patient-reported activity limitations preoperative
时间窗: Baseline (preoperatively)
The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used
Patient-reported activity limitations preoperative 1
时间窗: at postoperative sixth weeks
The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used
Quality of life-preoperative 1
时间窗: at postoperative sixth weeks
Short Form-36 (SF-36) is used
次要结局
- Length of operation time(the surgery)
- Amount of blood loss(through study completion, an average of 1 year)
- postoperative component alignments(through study completion, an average of 1 year)
研究者
Harun Resit Gungor
Prof. Dr
Pamukkale University