A Comparative Study Between Continuous Epidural Analgesia Versus Ultrasound Guided Continuous Femoral Nerve Block (CFNB) Versus Ultrasound Guided Continuous Adductor Canal Block (ACB) for Post-operative Pain Management After Total Knee Replacement (TKR).
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pain score
研究概览
简要总结
Aim of this study is to compare post-operative analgesic efficacy of continuous epidural analgesia versus ultrasound guided continuous femoral nerve block and adductor nerve block after unilateral total knee replacement using 0.125% bupivacaine.
详细描述
All patients will be assessed preoperatively, and will be instructed to fast for 8 hrs. On arrival to the operation theatre, Intravenous access will be established, and Ringer's solution will be infused as a co-load fluid bolus. Monitors for non-invasive blood pressure, heart rate, electrocardiogram (ECG), and pulse oximetry (SpO2) will be used to monitor the perioperative vital parameters of patients.
Before the spinal anesthesia, the epidural catheter will be inserted, while the femoral and adductor canal catheters will be inserted under ultrasound guidance before spinal anesthesia according to patient group allocation by single operator.
Group A: As for the epidural analgesia, it will be performed under complete aseptic precautions, by introducing a needle between the lumbar vertebrae at level of L3-L4 or L4-L5 and injecting anesthetic medication into the epidural space, via the epidural catheter inserted through the needle into the epidural space.
The epidural needle (typically 18-gauge and 8.89 cm (3.5 inches) in length) is inserted in the midline of the patient's back, defined by the spinous processes at the chosen spinal level. A skin wheal is raised with 1% lidocaine using a 25-gauge needle in the midline of the spine, in the lower third to half of the interspace. The subcutaneous tissue is infiltrated with lidocaine and is continued through supraspinous ligament down to the interspinous ligament.
The epidural needle is inserted with stylet at a straight or slight cephalad angle or at steeper cephalad angle. The needle bevel is oriented cephalad while the patient is in a sitting position. The needle is advanced through the supraspinous ligament and into the interspinous ligament. A firmness in the tissue suggests that the tip of the needle is in the supraspinous or interspinous ligament. Lack of firmness may indicate a paraspinous position of the needle tip, and the needle should be adjusted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •.American Society of Anesthesiologists physical status (ASA) is I to III. .Both genders. .More than 40 years old.
排除标准
- •.Major spine deformities. .Bleeding disorders and coagulopathy. .Infection at the injection site. .Allergy to local anesthetics. .Pre-existing myopathy or neuropathy. .Significant cognitive dysfunction. .Patient refusal to participate.
研究组 & 干预措施
ultrasound guided adductor canal block inserted before spinal anesthesia.
As for the adductor canal block,using a transportable Sonosite M-Turbo ultrasound system with linear transducer placed perpendicular to the thigh at the midpoint between the anterior superior iliac spine and the base of the patella,The needle used for the block will be an echogenic needle of 18 Gauge and 3.5 inches. Before proceeding, skin infiltration with local anesthesia will be done using a syringe containing 5ml of 1% lidocaine, the saphenous nerve is identified as it lies adjacent proximally lateral then distally superior to the femoral artery. Saphenous nerve is followed distally as it becomes more superficial, traveling with an arterial branch just deep to the sartorius muscle. Using an in-plane approach, after negative aspiration, the tip of the needle is placed deep to the sartorius muscle, at the lateral border of the artery, Once the needle is in position, the catheter is introduced through it, then the needle is removed.
干预措施: bupivacaine and fentanyl (Procedure)
ultrasound guided femoral nerve catheter inserted before spinal anesthesia.
As for the femoral nerve block, it will be performed under complete aseptic precautions, using a transportable Sonosite M-Turbo ultrasound system with linear transducer placed on the femoral crease to obtain the images of the femoral nerve & artery.
The needle used for the block will be an echogenic needle of 18 Gauge and 3.5 inches. Before proceeding, skin infiltration with local anesthesia will be done using a syringe containing 5ml of 1% lidocaine, Once the femoral nerve is visualized, the needle will be inserted in-plane in a lateral to medial orientation and advanced towards the nerve. Once the tip placed adjacent to the nerve, the catheter is introduced through it, then the needle is removed, the location of the catheter can be confirmed by visualization of the catheter and spread of local anesthetic (LA).
干预措施: bupivacaine and fentanyl (Procedure)
epidural catheter inserted before spinal anesthesia.
As for the epidural analgesia, it will be performed under complete aseptic precautions, by introducing a needle between the lumbar vertebrae at level of L3-L4 or L4-L5 and injecting anesthetic medication into the epidural space, via the epidural catheter inserted through the needle into the epidural space.
A small amount of air (1 to 2 mL) may be injected into the epidural space, avoid injecting larger amounts of air as this may contribute to patchy anesthesia.
干预措施: bupivacaine and fentanyl (Procedure)
结局指标
主要结局
pain score
时间窗: 48 hours
Visual analogue score from 0 to 10
次要结局
- hemodynamic changes(48 hours)
研究者
remon nadhy
Assistant lecturer
Ain Shams University