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临床试验/NCT04104204
NCT04104204Unknown不适用

The Efficacy of Pain Control After Total Hip Replacement Between Ultrasound Guide Supra-inguinal Fascia Iliaca Block and Intrathecal Morphine: A Randomized Controlled Trial

Mahidol University1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2019年12月3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
入组人数
98
试验地点
1
主要终点
Time to first analgesic request (PCA fentanyl)

研究概览

简要总结

Total hip replacement is one of major orthopedic surgery which result in severe postoperative pain especially at first 24 hours. Ultrasound guided regional anesthesia has become a part of multimodal analgesia.Ultrasound guided supra-inguinal fascia iliaca block is a new technique which can consistently cover femoral and lateral femoral cutaneous nerve. And with large volume (40ml), it may cover obturator nerve. This technique already proved to be useful for acute pain control in hip fracture or postoperative control in dynamic hip screw or nail insertion operation. However, it has not been compared with intrathecal morphine for total hip replacement yet.

详细描述

By using combine ultrasound guided supra-inguinal fascia iliaca block with periarticular infiltration with mutimodal analgesic drugs will have longer duration time to first rescue analgesic drug compared with combine intrathecal morphine with periarticular infiltration with multimodal analgesic drugs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • elective surgery of primary total hip replacement, body weight ≥40kg and BMI ≤35 kg/m2, competence to consent

排除标准

  • contraindication to regional anesthesia, allergy to study drugs, skin infection at supra-inguinal fascia iliaca injection point, neurological deficit affecting the lower extremities, inability to use patient-controlled analgesia, GFR <50 mL/min

研究组 & 干预措施

Intrathecal morphine

Sham Comparator

Intrathecal morphine 0.1 mg, A sham subcutaneous injection of 0.5 ml normal saline at inguinal area

干预措施: Intrathecal morphine (Drug)

Ultrasound guided supra-inguinal fascia iliaca block

Experimental

0.25% bupivacaine 40 ml

干预措施: Ultrasound guided supra-inguinal fascia iliaca block (Drug)

结局指标

主要结局

Time to first analgesic request (PCA fentanyl)

时间窗: 48 hours

Whether ultrasound guided supra-inguinal fascia iliaca block can increase pain free period of patients undergo total hip replacement under spinal block compare with intrathecal morphine or not

次要结局

  • Pain score(48 hours)
  • Amount of rescue analgesic drugs(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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