Evaluation of the Effects of Regional Anesthesia Methods Applied in Total Knee Arthroplasty on Joint Range of Motion in the Postoperative Period and Patient Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Postoperative Knee Range of Motion (ROM)
研究概览
简要总结
This is a single-center, prospective, randomized controlled trial aiming to evaluate the effects of different regional anesthesia/analgesia techniques on postoperative knee range of motion (ROM) and patient satisfaction following total knee arthroplasty (TKA). Ninety patients undergoing elective TKA under spinal anesthesia will be randomly assigned to one of three groups: 1) spinal anesthesia with epidural catheter, 2) spinal anesthesia followed by adductor canal catheterization, and 3) spinal anesthesia with multimodal intravenous analgesia. The primary outcome is postoperative knee joint ROM measured on postoperative days 1, 2, and 3. Secondary outcomes include patient satisfaction, Oxford Knee Score, postoperative opioid consumption, and VAS scores. The study is conducted at Konya City Hospital and will be completed over a 6-month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum Age: 18 Years
- •Maximum Age: None
- •Gender Based: No
- •Accepts Healthy Volunteers: No
- •Inclusion Criteria:
- •Scheduled for primary total knee arthroplasty
- •Age ≥ 18 years
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Accepting neuraxial anesthesia
排除标准
- •Skin infection at the planned injection site
- •Coagulopathy
- •Refusal of neuraxial anesthesia
- •Severe hypovolemia
- •Demyelinating central nervous system disease
- •Age under 18 years
- •Illiterate in Turkish
- •Non-cooperative patients
- •Known allergy or hypersensitivity to bupivacaine
研究组 & 干预措施
Combined Spinal-Epidural Anesthesia
Postoperative analgesia will be provided via epidural catheter with programmed infusion of bupivacaine .
干预措施: Regional anethesia (Procedure)
Adductor Canal Block
Ultrasound-guided adductor canal catheter placement and continuous infusion of bupivacaine .
干预措施: Regional anethesia (Procedure)
Multimodal Intravenous Analgesia
Continuous intravenous tramadol infusion with rescue analgesia as required.
干预措施: Regional anethesia (Procedure)
结局指标
主要结局
Postoperative Knee Range of Motion (ROM)
时间窗: Postoperative day 1, day 3, day 7, and day 90 after surgery.
Knee joint flexion and extension range of motion will be measured using a standard goniometer by a blinded assessor. Measurements will be performed with the patient in a supine position, ensuring standardized positioning for all participants.
次要结局
- Oxford Knee Score (OKS)(Preoperatively (baseline) and postoperative day 90.)
- Patient Satisfaction Score(Postoperative day 3 and day 90 after surgery.)
- Total Opioid Consumption(From the end of surgery to 72 hours postoperatively.)
- Visual Analog Scale (VAS) Pain Score(Postoperative day 1, day 3, and day 7 after surgery.)
- Incidence of Adverse Events Related to Anesthesia or Analgesia(Intraoperative period and up to 90 days postoperatively.)
研究者
Yasin Tire, MD
Assoc. Prof. Dr. Yasin Tire
Konya City Hospital