Pain After Preoperative UltraSound Guided Hip Injections for Total Hip Arthroplasty (PUSH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Accuracy
研究概览
简要总结
The purpose of the study is to assess the accuracy of Butterfly IQ ultrasound for intra-articular hip injections, and to see if an injection given intra-articular before incision provides any benefit in preemptive pain relief or blood loss reduction.
详细描述
This study is designed to be prospective randomized (1:1) controlled independent trial. Subjects are male and female, aged 18 and above, who are suitable candidates for either a unilateral (i.e. single) total hip replacement. Subjects that are scheduled with a single, extensively trained Physician Assistant assisting in their surgery will be exclusively included. This is single site study with projected enrollment of 150 subjects
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
- Double (Care Provider, Investigator)
盲法说明
Only the surgeon and PA will be aware of the randomization assignment
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
- 否
入选标准
- •Subjects meeting all of the following specific criteria will be considered for participation in the study:
- •Subject is between 18-80 years of age.
- •Subject is a suitable candidate for total hip replacement.
- •Subject scheduled for surgery with the Butterfly IQ trained PA providing surgical assistance
- •Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to AAHS RI
- •Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedure and follow-up visits and co-operate with investigational procedures.
- •Subject must be comfortable with speaking, reading, and understanding questions in English and providing an appropriate response.
排除标准
- •Subjects will be excluded from participation in the study if they meet any of the following criteria:
- •Subject is a woman who is pregnant or lactating
- •Subject from the vulnerable groups: prisoners, adults unable to consent, children, non-English speaking, illiterate, and/or visually impaired)
- •Subject who is not comfortable with speaking, reading, and understanding questions in English and providing an appropriate response.
- •Subject who cannot or refuses to give voluntary, written informed consent to participate in this clinical trial
- •Subject has contraindications for any of the following: Ropivicaine, Epinephrine or Methylene Blue
- •Previous hip surgery
- •History of infection in hip
- •Morbid obesity defined as BMI>40
结局指标
主要结局
Accuracy
时间窗: Surgery
Primary objective is to determine the accuracy of the Butterfly IQ portable app based ultrasound device used in intra-articular hip injections determined by patient reported pain ratings using the Patient Reported Outcome Measure Information System (PROMIS) pain rating 0(no pain)- 5 (most pain)
次要结局
- Blood Loss(Postoperative day 1)
研究者
Paul King
Director of the Center for Joint Replacement
Anne Arundel Health System Research Institute