Are Preemptive Femoral and Lateral Femoral Cutaneous Nerve Blocks Given Immediately Prior to Hip Arthroscopy(THA) Effective for Acute Postoperative Pain Management?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Pain Numerical Rating Scale Score (NRS 0-10)
研究概览
简要总结
The goal of the study is to evaluate via a prospective, blinded, randomized clinical trial, whether ultrasound-guided single femoral and lateral femoral cutaneous nerve blocks with ropivacaine 0.5% with epinephrine (1:200,000) as a tracer for intravascular injection (total 30 ml) vs. saline with epinephrine (1:200,000) (total 30 ml), given just prior to same day elective hip arthroscopy, is effective in reducing acute postoperative pain (NRS scores), postoperative opiate consumption, and time to discharge from the postanesthesia care unit. Differences between groups with respect to postoperative quality of life and functional scores will also be evaluated.
详细描述
The purpose of this study is to evaluate whether ultrasound (using sound waves to produce an image)-guided regional anesthesia (local numbing medicine) to the hip area given in addition to general anesthesia just prior to same day elective hip arthroscopy, is effective in reducing acute postoperative pain, and time to discharge from the post anesthesia care unit. In addition, the study aims to examine whether this regional anesthesia medication has any effect on the study subjects' use of pain medication both during and after the procedure, return to function, and quality of life in the 6 month period after the surgical procedure. Although hip arthroscopy is a routine procedure, the best method for pain control is not well established, and is the purpose of this study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 year old,
- •ASA physical status classification system score (ASA) <=3
- •due to undergo elective unilateral hip arthroscopy by one surgeon Dr. Nho (Co-Principal Investigator)
排除标准
- •ASA physical status classification system score) (ASA) >3
- •history of opioid dependence or abuse
- •current chronic analgesic therapy (daily use =>20 mg oxycodone-equivalent opioid use within 2 weeks before surgery and duration of use >=4 weeks)
- •allergy to study medications (fentanyl and ropivicaine)
- •any neuromuscular deficit of the ipsilateral femoral nerve or quadriceps femoris muscle (including diabetic peripheral neuropathy)
- •diagnosis of hypertension and/or current treatment for hypertension
- •pregnancy
研究组 & 干预措施
Grp 1 Ropivacaine Block
Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)
干预措施: Ropivacaine (Drug)
Grp 2 Placebo Block
Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)
干预措施: Placebo (Drug)
结局指标
主要结局
Pain Numerical Rating Scale Score (NRS 0-10)
时间窗: 6 months postoperative
The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.
次要结局
- Veterans Research and Development (RAND) 12 Item Health Survey (VR-12) Scores(Preoperative 2-8 wks)
- Veterans RAND 12 Item Health Survey (VR-12) Scores(6 months postoperative)
研究者
Sandeep Amin, MD
Assistant Professor, Attending Anesthesiologist
Rush University Medical Center