跳至主要内容
临床试验/NCT01194505
NCT01194505已完成不适用

Comparison of Posterior Lumbar Plexus Block Plus Sciatic Nerve Block With Sciatic Plus Femoral Plus Obturator Nerve Block for Anterior Cruciate Ligament Reconstruction

Larissa University Hospital2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2010年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
106
试验地点
2
主要终点
Feasibility of ACL reconstruction surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block measured with Pain Score on the Visual Analog Scale

研究概览

简要总结

Anterior Cruciate Ligament ACL reconstruction can be performed under the combination of posterior lumbar plexus block plus sciatic nerve block. The investigators can have the same outcome by performing instead of posterior lumbar plexus block more peripheral nerve blocks. More specifically under the combination of sciatic nerve block plus femoral nerve block plus obturator nerve block.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

The patient, the orphopaedic surgeon and the anesthesiologist in the OR did not know at which group the patient belonged to.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-50 years old
  • ASA I - II
  • ACL reconstruction surgery

排除标准

  • Coagulopathy disorders
  • Infection at the puncture site for the interscalene block
  • Neurologic deficit in the arm that is going to be operated
  • Allergy to local anesthetics
  • BMI > 35
  • Psychiatric disorders
  • Patient's refusal
  • Problems with patient communication

研究组 & 干预措施

ACL, sciatic, femoral, obturator

Active Comparator

ACL reconstruction surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block

干预措施: Sciatic, femoral, obturator nerve blocks (Other)

ACL, sciatic nerve block, posterior lumbar plexus block

Active Comparator

ACL reconstruction surgery under ultrasound guided sciatic nerve block plus posterior lumbar plexus block

干预措施: Sciatic nerve block, posterior lumbar plexus block (Other)

结局指标

主要结局

Feasibility of ACL reconstruction surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block measured with Pain Score on the Visual Analog Scale

时间窗: 45 min

If the patient complains for pain \> 4 in VAS and there is no relief with fentanyl administration the anesthesia plan converts to general anesthesia with laryngeal mask

次要结局

  • Intraoperative opioid consumption for ACL reconstruction surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block(Intraoperatively)
  • Postoperative opioid consumption for ACL reconstruction surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block(24h)

研究者

发起方
Larissa University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Metaxia Bareka

Anesthesiologist

Larissa University Hospital

研究点 (2)

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