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临床试验/NCT02108847
NCT02108847已完成不适用

Ultrasound Guided Fascia Iliaca Block for Postoperative Analgesia After Elective Total Hip Arthroplasty

University of Saskatchewan1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2014年4月最近更新:
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
入组人数
42
试验地点
1
主要终点
Cumulative opioid consumption

研究概览

简要总结

The purpose of this study is to determine whether ultrasound guided fascia iliaca blocks performed before surgery help to reduce pain after elective total hip replacements.

详细描述

Total hip arthroplasty is associated with moderate to severe pain in the acute postoperative period, which can increase the risk of postoperative complications such as thromboembolism, myocardial ischemia/infarction, pneumonia, poor wound healing, insomnia, and delirium.

Sensory innervation of the hip joint comes from a combination of peripheral nerves, including femoral, obturator, sciatic, superior gluteal, and nerve for the quadratus femoris muscle. Superficial innervation of the skin involved in incision for hip arthroplasty comes from the lateral femoral cutaneous nerve (LFCN).

The fascia iliaca block (FIB) was originally described in 1989 using a landmark technique. The ultrasound guided FIB was introduced in recent years, and has been shown to produce a better quality of block than the landmark technique. It appears to consistently block the femoral and LFCN, while being less successful in achieving consistent obturator blockade.

The FIB is effective for analgesia for hip fracture injuries in the emergency department. Thus far, there has been limited exploration into the potential use of this block as a tool for postoperative analgesia after elective hip arthroplasty. The potential benefits of this regional block, as with other regional techniques, include better analgesia, less opioid use and associated side effects, and an improved overall patient satisfaction with postoperative recovery.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists' (ASA) score I, II or III
  • Scheduled for elective total hip arthroplasty

排除标准

  • Contraindication to regional anesthesia (allergy to local anesthetic, coagulopathy, infection or malignancy in the area)
  • Neurologic disorder affecting the ability to sense pain
  • Long term opioid use or chronic pain disorder
  • History of drug or alcohol abuse
  • Patient refusal
  • Pregnancy
  • Revision procedures
  • General anesthetic
  • Psychiatric or mental conditions that may affect assessment of outcomes

研究组 & 干预措施

Fascia Iliaca Block - Ropivacaine

Experimental

Ultrasound guided fascia iliaca block performed preoperatively with 40 mL of 0.2% ropivacaine.

干预措施: .2% Ropivacaine (Drug)

Fascia Iliaca Block - Ropivacaine

Experimental

Ultrasound guided fascia iliaca block performed preoperatively with 40 mL of 0.2% ropivacaine.

干预措施: Fascia Iliaca Block (Procedure)

Fascia Iliaca Block - Saline

Sham Comparator

Ultrasound guided fascia iliaca block performed preoperatively with 40 mL of Saline.

干预措施: Saline (Drug)

Fascia Iliaca Block - Saline

Sham Comparator

Ultrasound guided fascia iliaca block performed preoperatively with 40 mL of Saline.

干预措施: Fascia Iliaca Block (Procedure)

结局指标

主要结局

Cumulative opioid consumption

时间窗: 24 hours after surgery

Dilaudid will be used for analgesia postoperatively. If there is a contraindication to Dilaudid, another opioid will be ordered for analgesia, and doses will subsequently be converted back to Dilaudid equivalent doses for comparison

次要结局

  • Cumulative opioid consumption(4, 8, and 48 hours after surgery)
  • Opioid side effect (nausea/vomiting, pruritus, constipation, urinary retention, sedation)(PACU, 4, 8, 12, 24, and 48 hours after surgery)
  • Verbal pain score (static and dynamic)(PACU, 4, 8, 12, 24, and 48 hours after surgery)
  • Overall patient satisfaction(48 hours after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacelyn Larson

M.D.

University of Saskatchewan

研究点 (1)

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