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临床试验/NCT03231319
NCT03231319Unknown不适用

Comparison of Different Neural Blockade Techniques in Postoperative Analgesia After Total Hip Arthroplasty

Taichung Veterans General Hospital3 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年7月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
90
试验地点
3
主要终点
Temporal changes of Pain score

研究概览

简要总结

To compare the different analgesic protocols for patients receiving total hip arthroplasty(THA). Patients will divided into 3 groups, which are 1. fascia iliaca compartment block with IV-PCA(patient controlled analgesia), 2. femoral nerve and lateral femoral cutaneous nerve block with IV-PCA, 3. IV-PCA only.

详细描述

90 patients will be enrolled and randomized to the 3 different groups.

  1. Inclusion criteria:

Patient undergoing THA: 20-75 years old, ASA I-III, general anesthesia with intubation, fentanyl IV PCA. 2. Exclusion criteria Alcohol/substance abuse Rheumatoid arthritis Severe coagulation disorder(PLT<80000 or INR > 1.5) Peripheral neuropathy Allergy to opioids or local anesthetics BMI>35 3. The outcome followers are blinded to the intervention provided. 4. Outcome parameters:

  1. Opioid consumption of IV PCA in first 24 hrs.
  2. NSAID consumption
  3. NRS of pain, the timings of follow-up should be: pre-block, 30

mins post-block, 60 mins post-block, 2 hours post-block, 24hours post-block 4. sensory block in FN, Obturator Nerve and LFCN 5. First request of supplemental IV analgesia

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I-III, general anesthesia with intubation.
  • fentanyl IV PCA

排除标准

  • Alcohol/substance abuse
  • Rheumatoid arthritis
  • Severe coagulation disorder(PLT<80000 or INR > 1.5)
  • Peripheral neuropathy
  • Allergy to opioids or local anesthetics

研究组 & 干预措施

IV PCA only

Placebo Comparator

干预措施: IV-PCA (Procedure)

fascia iliaca compartment block+ IV-PCA

Active Comparator

干预措施: Fascia iliaca compartment block with IV-PCA (Procedure)

femoral nerve and lateral femoral cutaneous nerve block+IV PCA

Active Comparator

干预措施: Femoral nerve block and lateral femoral cutaneous nerve with IV-PCA (Procedure)

结局指标

主要结局

Temporal changes of Pain score

时间窗: 1. Pre-intervention(which is the time when operation was done and the patient arrive postoperative care unit.) 2. 30 minutes after intervention, 3. 60 minutes after intervention, 4. 120 minutes after intervention, 5. 24 hours after intervention.

Pain score by numerical rating scale from pre-intervention to 24 hours after intervention(the effect of neural blockade seldom lasts more than 24 hours)

次要结局

  • NSAID consumptions(24 hours postoperatively)
  • Opioid consumptions(postoperatively 24 hours)
  • Sensory block in femoral nerve, obturator nerve and lateral femoral cutaneous nerve area(1 hour post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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