跳至主要内容
临床试验/NCT05212038
NCT05212038已完成不适用

An Iliopsoas Plane Block for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial

Gangnam Severance Hospital1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2022年2月15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
入组人数
56
试验地点
1
主要终点
Numeric rating scale pain score at rest

研究概览

简要总结

Nielsen et al. reported that when iliopsoas plane block was performed on healthy volunteers, the injection solution in Hip MRI was confined to the myofascial compartment, which was known to include all sensory branches of the femoral nerve that control the hip joint. The maximal muscle strength of knee extension did not decrease before and after Iliopsoas plane block in Volunteer. Since there is no clinical study conducted on patients after the volunteer study, the investigators intend to evaluate the analgesic and motor preserving effects of the iliopsoas plane block in a group of patients undergoing total hip arthroplasty.

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
Double (Participant, Outcomes Assessor)

盲法说明

Double

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty

排除标准

  • •Revision total hip arthroplasty
  • •Allergy to drugs used in the study
  • •Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
  • •Estimated glomerular filtration rate < 30 mL/min/1.73m2
  • •Opioid dependence
  • •Prolongation of PT and aPTT more than twice the upper limit of normal
  • •Pre-existing neurological or anatomical disorders of the lower extremities
  • •Serious psychiatric disorders

研究组 & 干预措施

liopsoas plane block group

Experimental

Arm Description: a iliopsoas plane block before surgery

干预措施: iliopsoas plane block group (Procedure)

sham block group

Sham Comparator

sham block before surgery

干预措施: sham block group (Procedure)

结局指标

主要结局

Numeric rating scale pain score at rest

时间窗: up to 48 hours after the surgery

Pain intensity at rest will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) 1, 6, 24, and 48 hours after the surgery.

次要结局

  • Numeric rating scale pain score at movement(up to 48 hours postoperatively)
  • Postoperative opioid consumption(postoperative 24, 48hours)

研究者

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

Do-Hyeong Kim

Associate Professor

Gangnam Severance Hospital

研究点 (1)

Loading locations...

相似试验