Fascia Iliaca Block for Post-Operative Pain Control After Total Hip Arthroplasty: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Opioid Consumption
研究概览
简要总结
This study evaluates post-operative pain management and narcotic consumption in patients receiving a fascia iliaca block with local anesthetic versus patients receiving fascia iliaca block with saline for total hip arthroplasty.
详细描述
Although many improvements have been made in implant technology and surgical approaches for total hip arthroplasty, management of post-operative pain remains a major clinical issue. Inadequate pain control can lead to numerous unwanted side effects and limited physical function, especially in a older population. Most surgeons have adopted a multi-modality pain management approach using a variety of pharmaceuticals, including nerve block with local anesthetic. In the literature, there are a number of technical variations described for the fascia iliaca nerve block. At The Christ Hospital, Cincinnati, Ohio, anesthesiologists use a more proximal approach to the fasica iliaca block enabling a significantly easier cephalad spread of the local anesthetic into the pelvis targeting all three nerves; the femoral, lateral femoral cutaneous, and the obturator.
This prospective, double-blinded, randomized, single-center study is designed to test the primary hypothesis that fascia iliaca block with a local anesthestic decreases narcotic consumption and provides improved pain control compared to placebo in the first 24 hours after surgery in 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •anterior approach total hip arthroplasty (THA) for unilateral osteoarthritis
- •English-speaking
- •age 18 to 75 years
- •American Society of Anesthesiologists (ASA) physical status 1 to 3
- •BMI < 40 kg/m2
- •Minimum weight of 50 kg.
- •No contraindications to study procedures
排除标准
- •Hip revision surgery
- •Allergy to local anesthetics
- •Allergy to oxycontin
- •Allergy to pregabalin
- •Allergy to fentanyl
- •Allergy to midazolam
- •Allergy to hydromorphone
- •BMI > 40 kg/m2
- •Chronic pre-operative opioid use
研究组 & 干预措施
ropivacaine block
Ropivacaine 0.375% as a one-time 60 milliliter injection.
干预措施: Ropivacaine (Drug)
saline block
Sodium chloride 0.9% as a one-time 60 milliliter injection.
干预措施: Saline (Drug)
结局指标
主要结局
Opioid Consumption
时间窗: 24 hours
Measured by IV narcotic consumption beginning in the post-operative care unit and continuing 24 hours on the post-operative floor.
Pain Control
时间窗: 24 hours
Measured by NRS-11 beginning in post-operative care unit and continuing 24 hours on the post-operative floor.
次要结局
- Post-Operative Care Unit (PACU) Length of Stay(From 60 minutes to 6 hours)
研究者
Brian Vaughan
Brian Vaughan, MD
The Christ Hospital
