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临床试验/NCT02701296
NCT02701296已完成不适用

Assessment of Knee Pain in Patients Receiving Continuous Femoral Nerve Block Combined With Either Ultrasound Guided Posterior Capsular Injection or Selective Tibial Nerve Block Following Total Knee Arthroplasty

Trinity Health Of New England1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年11月7日最近更新:
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
发起方
入组人数
80
试验地点
1
主要终点
Pain Intensity

研究概览

简要总结

To assess pain control after total knee replacement surgery using two different nerve block techniques. The 2 methods are:

  1. Continuous femoral nerve block with ultrasound guided posterior capsular injection
  2. Continuous femoral nerve block with ultrasound selective tibial nerve block.

详细描述

Patients undergoing total knee replacement surgery experience severe post-operative pain. Continuous femoral nerve block combined with selective tibial nerve block provides optimal pain control in the anterior and posterior aspect of the knee respectively. However, in patients with pre-existing neuropathy of the sciatic nerve, the blockade of tibial nerve is contraindicated because of increased risk of nerve damage that may lead to exacerbation of neurologic symptoms. In such patients where selective tibial nerve block cannot be offered, ultrasound guided posterior knee capsular injection may be an alternative technique for controlling posterior knee pain after surgery. Posterior capsular injection by surgeons intraoperatively, when combined with femoral nerve block has been shown to provide pain control after total knee replacement. With posterior capsular injection, the main trunk of the tibial nerve is spared and only the terminal nerve endings innervating the posterior knee joint is blocked providing effective pain control. In this study, the efficacy of ultrasound guided posterior capsular injections performed pre-operatively will be compared to tibial nerve block in controlling knee pain after surgery.

The results of this study may help establish the efficacy of ultrasound guided posterior capsular injection as an alternative to tibial nerve block in patients undergoing total knee arthroplasty.

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, Care Provider)

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

  • Patients having primary, unilateral total knee arthroplasty
  • Age 18-80

排除标准

  • History of neurologic disease, neuropathy, diabetes, or major systemic illness
  • Allergy to local anesthetic solution or NSAIDs
  • Pregnancy
  • Chronic use of narcotics
  • Inability to give consent/cooperate with study

研究组 & 干预措施

Posterior capsular injection

Experimental

Ultrasound guided posterior capsular injection of ropivacaine with epinephrine

干预措施: Ropivacaine with Epinephrine (Drug)

Tibial nerve block

Active Comparator

Ultrasound selective tibial nerve block of ropivacaine

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Pain Intensity

时间窗: 48 hours post surgery

Mean Numeric Pain Rating Scale (NPRS) self-reported pain Intensity on a 11-point score (0=no pain to 10= worst possible) in Post Anesthesia Care Unit (PACU) and every 6 hours for 48 hours post surgery

次要结局

  • Opioid Consumption(24 hours post surgery)
  • Plantar Flexion in the Tibial Nerve Distribution(Upon emergence from anesthesia in the PACU)
  • Cold Sensation in the Tibial Nerve Distribution(Upon emergence from anesthesia in the PACU)
  • Dorsiflexion in the Peroneal Nerve Distribution(Upon emergence from anesthesia in the PACU)
  • Sensation in the Peroneal Nerve Distribution(Upon emergence from anesthesia in the PACU)

研究者

发起方
Trinity Health Of New England
申办方类型
Other
责任方
Sponsor

研究点 (1)

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