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临床试验/NCT02106481
NCT02106481已完成不适用

Comparison of a Single Shot Femoral Nerve Block to Femoral Nerve Block Shot Plus Continuous Femoral Nerve Catheter for Total Knee Replacement Surgery; a Randomized, Blinded Controlled Trial.

Eastern Maine Medical Center1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
99
试验地点
1
主要终点
Pain

研究概览

简要总结

The purpose of this study is to compare two methods of pain control used during total knee joint replacement surgery. The pain medication that will be used for this study is not experimental.

The investigators will compare the single shot femoral nerve block (SSFNB) and Femoral Nerve Block (FNB) plus continuous femoral nerve catheter (CFNC) to determine which method gives patients better pain control, increasing the capability to participate in physical therapy and decreasing the consumption of other pain medication. With either the single shot or the catheter the local numbing medication called ropivacaine will be used.

详细描述

The study will be a randomized controlled blinded study with a sham control arm. The patients will be randomized to either a single shot FNB with placement of a catheter on the skin (sham control) or a conventional CFNC with catheter.

The group with SSFNB will receive a femoral nerve block before the surgery in the pre-operative area guided by a nerve stimulator and ultrasound. A bolus of 0.5 % ropivacaine will be injected around the femoral nerve. A catheter would be placed on the skin, without penetration, with occlusive dressing applied over the site. A standard size saline bag will be placed on the pump but will not be turned on. The tubing will be opaque and a bag will be placed over the pump to blind the patient to the medication, or lack of medication, being administered. The patient, nursing staff and physical therapists will be blinded to the presence of a sham catheter. The infusion will be labelled 'Study Drug R' or 'Study Drug N' in the electronic medicine prescription.

The group randomized with active drug by CFNB would have a continuous femoral catheter placed using nerve stimulator and ultrasound. Catheter will be bolused with 0.5 % ropivacaine around the femoral nerve and occlusive dressing applied over the catheter.

After placement of the femoral nerve block patients will be transported to the operating room and spinal anesthesia with bupivacaine and fentanyl will be performed. Intra-operative sedation of propofol infusion will be titrated to the discretion of the anaesthesia team. Patients will receive scheduled as well as rescue analgesia as per clinical pathway protocol.

Patients with CFNB will receive ropivacaine 0.2% infusion (the infusion rate will be dependent on the clinical judgement of the anaesthesiologist) in the post anaesthesia care unit (PACU) after the spinal anaesthesia has worn off. The infusion will be continued for the duration of the catheter, 4am POD one. Patients with SSFNB will not receive any infusion through the sham catheter.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (18-80 years old)
  • Scheduled to undergo primary unilateral TKA with Parapatellar approach
  • Patient agrees to participate in the study
  • Effective femoral nerve block
  • No contraindication for spinal or regional anesthesia

排除标准

  • History of opioid dependence or current chronic analgesic therapy (daily use >4 weeks
  • Allergy to study medications
  • Known hepatic or renal insufficiency/disease
  • Peripheral neuropathy
  • Morbid obesity (BMI >40 kg/m2)
  • Unable to comply with study protocol
  • Pregnancy
  • Incarceration

研究组 & 干预措施

Femoral Nerve Catheters

Active Comparator

Patients will receive a Single Shot Femoral Nerve Block along with a conventional continuous femoral nerve catheter

干预措施: Femoral Nerve Catheters (Drug)

Femoral Nerve Catheters

Active Comparator

Patients will receive a Single Shot Femoral Nerve Block along with a conventional continuous femoral nerve catheter

干预措施: Single Shot Femoral Nerve Blocks (Drug)

Single Shot Femoral Nerve Blocks

Active Comparator

Patients will receive a Single Shot Femoral Nerve Block and a sham catheter post op.

干预措施: Single Shot Femoral Nerve Blocks (Drug)

结局指标

主要结局

Pain

时间窗: 48 hours post operatively

Pain Analog Scale- 0-10 were 10 is the worst possible pain and 0 is no pain at all.

次要结局

未报告次要终点

研究者

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

Varun Dixit

Anesthesiologist

Eastern Maine Medical Center

研究点 (1)

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