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临床试验/NCT02355093
NCT02355093Unknown4 期

Adductor Canal Block Versus Femoral Nerve Block for Analgesia After Anterior Cruciate Ligament Reconstruction Arthroscopically

Shanghai Jiao Tong University Affiliated Sixth People's Hospital0 个研究点目标入组 40 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
40
主要终点
quadriceps muscle strength, as measured by handheld dynamometer.

研究概览

简要总结

This study aims to compare continuous femoral nerve block with adductor canal block after anterior cruciate ligament reconstruction arthroscopically,especially in the effect on quadriceps strength; and to evaluate which regional anesthesia is more ideal for the patients postoperatively.

详细描述

Forty patients with American Society of Anesthesiologists(ASA) Ⅰ-Ⅲ(no limitation of age and gender)are randomized to receive either a continuous adductor canal block(ACB) or a femoral nerve block(FNB) via a catheter (a continuous infusion of 0.2% ropivacaine, 5 mL/h for 48 hours)in the PACU immediately after the anterior cruciate ligament reconstruction arthroscopically. Patients were under general anesthesia during the operation and received a femoral nerve block with 0.25% ropivacaine 10ml before the surgery.Both groups will receive postoperatively IV patient controlled analgesia (PCA) with morphine (bolus 0.8mg,lock-out time 15 minutes, background infusion 2ml/h)beside the continuous nerve block. Patients are going to be visited for follow-up on the day of surgery and in the following two days. Quadriceps strength is assessed with the displacement of patella.VAS at rest time、degree of knee flexion、VAS at 45°flexion of the knee、dose of opioids、whether the patient has sleep disturbance are also recorded.

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
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Anterior Cruciate Ligament Reconstruction

排除标准

  • patient refusal
  • chronic use of opioids
  • coagulation disorders
  • infection at the puncture site
  • allergic to anaesthetic
  • preexisting neurological disorders
  • communication difficulties

研究组 & 干预措施

adductor canal block (ACB)

Experimental

We performed an ultrasound survey at the medial part of the thigh,the needle is introduced in-plane and 2 to 3 mL of saline is used to ensure correct placement of the needle in the vicinity of the saphenous nerve in the adductor canal,the catheter is introduced and advanced 1 to 2 cm beyond the tip of the needle.The study medication is administered as an infusion of 0.2% ropivacaine at a rate of 5mL/h during the next 48 hours.

干预措施: adductor canal block (ACB) (Procedure)

adductor canal block (ACB)

Experimental

We performed an ultrasound survey at the medial part of the thigh,the needle is introduced in-plane and 2 to 3 mL of saline is used to ensure correct placement of the needle in the vicinity of the saphenous nerve in the adductor canal,the catheter is introduced and advanced 1 to 2 cm beyond the tip of the needle.The study medication is administered as an infusion of 0.2% ropivacaine at a rate of 5mL/h during the next 48 hours.

干预措施: ropivacaine (Drug)

Femoral nerve block (FNB)

Active Comparator

the catheter is inserted in-plane with the probe parallel to the inguinal crease, to obtain a short-axis view of the nerve. The correct needle placement is confirmed by injecting 2 to 3 mL of saline to cause tissue expansion below the iliac fascia, lateral to the femoral artery, and in the vicinity of the femoral nerve. The catheter is introduced 1 to 2 cm beyond the tip of the needle,an infusion of 0.2% ropivacaine at a rate of 5mL/h is administered during the next 48 hours.

干预措施: Femoral nerve block (FNB) (Procedure)

Femoral nerve block (FNB)

Active Comparator

the catheter is inserted in-plane with the probe parallel to the inguinal crease, to obtain a short-axis view of the nerve. The correct needle placement is confirmed by injecting 2 to 3 mL of saline to cause tissue expansion below the iliac fascia, lateral to the femoral artery, and in the vicinity of the femoral nerve. The catheter is introduced 1 to 2 cm beyond the tip of the needle,an infusion of 0.2% ropivacaine at a rate of 5mL/h is administered during the next 48 hours.

干预措施: ropivacaine (Drug)

结局指标

主要结局

quadriceps muscle strength, as measured by handheld dynamometer.

时间窗: 3 days

次要结局

  • pain at rest time and during flexion of the knee, as measured by visual analog score(VAS).(3 days)

研究者

发起方
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daqiang Zhao

Daqiang Zhao

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

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