Investigation of the Effectiveness of Adductor Canal Block and Suprainguinal Fascia Iliaca Block in Patients Planned for Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Numeric Rating Scale (NRS)
研究概览
简要总结
In total knee arthroplasty, the effectiveness of some peripheral nerve blocks in postoperative pain control has been investigated, with conflicting results reported. The primary aim of this study is to evaluate the effects of the suprainguinal fascia iliaca plane block, which is routinely performed in our clinic for postoperative pain management, and the adductor canal block in patients undergoing total knee arthroplasty under spinal anesthesia. Patients scheduled for total knee arthroplasty under spinal anesthesia will be randomly assigned using computer-generated randomization into two groups: the adductor canal block group (Group A) and the suprainguinal fascia iliaca plane block group (Group S). The nerve blocks will be performed by a single investigator according to the assigned group. Postoperative follow-up assessments will be conducted and recorded by a different investigator who is blinded to which nerve block was performed.
详细描述
This study will be conducted on patients undergoing total knee arthroplasty with spinal anesthesia at the operating room of Gaziosmanpaşa University Research and Application Hospital. Patients aged between 18 and 75 years, with American Society of Anesthesiologists (ASA) scores of 1-3, will be included in the study. Patients with a history of chronic pain, allergy to opioids or local anesthetics, psychiatric conditions that impair cooperation, or those who do not wish to participate voluntarily will be excluded.
Patients will be randomly assigned into two groups using a computer-generated randomization: the adductor canal block group (Group A) and the suprainguinal fascia iliaca plane block group (Group S). Postoperative monitoring in the recovery unit will include non-invasive measurements of ECG, blood pressure, heart rate, and SpO2.
According to their assigned group, patients will receive either ultrasound-guided suprainguinal fascia iliaca plane block or adductor canal block for postoperative analgesia control. Patients will be observed in the recovery room for an adequate period, after which a patient-controlled analgesia (PCA) pump will be routinely applied in our clinic. The PCA will be infused with an opioid-containing solution at an appropriate dose, and detailed patient information will be provided. Instead of continuous infusion, the device will deliver bolus doses intermittently when the patient's numeric rating scale (NRS) score reaches 4 or higher. If the patient's pain score remains 4 or above despite analgesic administration, routine intramuscular dicloron as rescue analgesia will be administered in our clinic. Patients will be periodically visited in bed, and data will be recorded regarding pain scores, motor strength of the operated limb, opioid consumption, use of rescue analgesia, and any complications. Follow-up assessments will be performed by a single experienced Anesthesiology and Reanimation specialist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 75 years
- •Patients classified as ASA I, II, or III based on physical status
- •Patients scheduled for total knee arthroplasty under spinal anesthesia
排除标准
- •Patients with chronic pain conditions.
- •Patients with a history of allergy to opioids or local anesthetics.
- •Patients with psychiatric disorders that may impair cooperation.
- •Patients with bleeding disorders or those using anticoagulant therapy.
- •Patients unwilling to participate voluntarily in the study.
研究组 & 干预措施
Group A
A patient who underwent total knee arthroplasty under spinal anesthesia will receive an adductor canal block, which is routinely performed with ultrasound guidance at our clinic for postoperative pain management. Postoperative patients will be visited at the 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours to assess pain, nausea, vomiting, itching, motor strength of the operated leg, and total opioid consumption.
干预措施: Opioid Analgesic (tramadol hydrochloride) (Other)
Group A
A patient who underwent total knee arthroplasty under spinal anesthesia will receive an adductor canal block, which is routinely performed with ultrasound guidance at our clinic for postoperative pain management. Postoperative patients will be visited at the 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours to assess pain, nausea, vomiting, itching, motor strength of the operated leg, and total opioid consumption.
干预措施: Prophylactic analgesia (intravenous paracetamol) (Other)
Group A
A patient who underwent total knee arthroplasty under spinal anesthesia will receive an adductor canal block, which is routinely performed with ultrasound guidance at our clinic for postoperative pain management. Postoperative patients will be visited at the 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours to assess pain, nausea, vomiting, itching, motor strength of the operated leg, and total opioid consumption.
干预措施: Rescue analgesia (intramuscular diclofenac sodium) (Other)
Group S
A patient who underwent total knee arthroplasty under spinal anesthesia will receive an suprainguinal fascia iliac plane block, which is routinely performed with ultrasound guidance at our clinic for postoperative pain management. Postoperative patients will be visited at the 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours to assess pain, nausea, vomiting, itching, motor strength of the operated leg, and total opioid consumption.
干预措施: Opioid Analgesic (tramadol hydrochloride) (Other)
Group S
A patient who underwent total knee arthroplasty under spinal anesthesia will receive an suprainguinal fascia iliac plane block, which is routinely performed with ultrasound guidance at our clinic for postoperative pain management. Postoperative patients will be visited at the 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours to assess pain, nausea, vomiting, itching, motor strength of the operated leg, and total opioid consumption.
干预措施: Prophylactic analgesia (intravenous paracetamol) (Other)
Group S
A patient who underwent total knee arthroplasty under spinal anesthesia will receive an suprainguinal fascia iliac plane block, which is routinely performed with ultrasound guidance at our clinic for postoperative pain management. Postoperative patients will be visited at the 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours to assess pain, nausea, vomiting, itching, motor strength of the operated leg, and total opioid consumption.
干预措施: Rescue analgesia (intramuscular diclofenac sodium) (Other)
结局指标
主要结局
Numeric Rating Scale (NRS)
时间窗: Postoperative patients will be visited and their pain scores will be evaluated at 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours
Numeric Rating Scale (NRS), is a simple and widely used tool for patients to rate their pain intensity. It typically involves asking the patient to select a number from 0 to 10, where: 0 indicates no pain at all, 10 represents the worst pain imaginable.
次要结局
- Total opioid consumption(The total amount of administered opioid (tramadol hydrochloride) within the first 24 hours postoperatively.)
- The patient's knee extension capability(Postoperative patients will be visited and their knee extension capability will be evaluated at 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours.)
研究者
Ali Genc
Assistant professor
Tokat Gaziosmanpasa University