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临床试验/NCT05249478
NCT05249478Unknown不适用

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).

Ain Shams University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
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

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.

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

remon nadhy

Assistant lecturer

Ain Shams University

研究点 (2)

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