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临床试验/NCT01219088
NCT01219088Unknown4 期

Post Operative Pain Control Among Intrathecal 0.1 mg Morphine, Femoral Nerve Block, or Periarticular Infiltration of 20 mL of 0.25% Bupivacaine in Patients Post Intramedullary Hip Screw

Mahidol University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
80
试验地点
1
主要终点
The amount of morphine consumption.

研究概览

简要总结

Falls are a common problem in elderly patients resulting fractured femur, which require early operation. Adequate postoperative pain control will provide good recovery. The investigators will compare the efficacy of postoperative pain control among intrathecal morphine, femoral nerve block, and periarticular infiltration with bupivacaine in patients undergone intramedullary hip screw under spinal anesthesia.

详细描述

Study methods :

Every patients without any exclusion criteria will be performed spinal anesthesia by 0.5% heavy bupivacaine then divided into 4 groups

  1. Controlled group : spinal anesthesia alone
  2. Femoral nerve block by 20 mL of 0.25% bupivacaine before spinal anesthesia
  3. Spinal anesthesia plus 0.1 mg morphine intrathecally
  4. Spinal anesthesia plus periarticular infiltration with 20 mL of 0.25% bupivacaine

All patients will receive postoperative intravenous patient controlled analgesia (IV PCA) morphine for 48 hours.

Data collection

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-90 years old
  • good consciousness, well co-operated, can use PCA machine
  • ASA class 1-3
  • no contraindication of spinal anesthesia
  • accept for spinal anesthesia
  • body weight > 30 kg
  • BMI 20-35 kg/m2
  • no history of research-drug allergy

排除标准

  • previous history of hip surgery (the same side)
  • pathological fractured such as severe infection, bone cancer

研究组 & 干预措施

Controlled group

No Intervention

Spinal anesthesia with 0.5% bupivacaine alone

干预措施: Bupivacaine, morphine (Drug)

Femoral nerve block

Active Comparator

Spinal anesthesia plus femoral nerve block with 20 mL of 0.25% bupivacaine

干预措施: Bupivacaine, morphine (Drug)

Intrathecal morphine

Active Comparator

Spinal anesthesia plus 0.1 mg of intrathecal morphine

干预措施: Bupivacaine, morphine (Drug)

Periarticular bupivacaine infiltration

Active Comparator

Spinal anesthesia plus periarticular infiltration with 20 mL of 0.25% bupivacaine

干预措施: Bupivacaine, morphine (Drug)

结局指标

主要结局

The amount of morphine consumption.

时间窗: 24 hours postoperative

次要结局

  • Efficacy of pain control(48 hours postoperative)

研究者

申办方类型
Other

研究点 (1)

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