Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Numeric Pain Score at 4 Hours Postoperatively, as Measured by Numerical Rating Scale (NRS) 11
研究概览
简要总结
The purpose of this study is to learn if using a suprainguinal fascia iliaca (SIFI) injection technique (also called a "nerve block") that numbs the nerves going to the side and front of the upper leg will improve pain control after surgery. The SIFI technique uses a numbing solution (local anesthetics) that is injected next to nerves in the hip to reduce pain. This block may affect movement in the leg and make the legs weak. The amount of leg weakness is not known and assessment of this will be included in the study. Many institutions use the SIFI block for patients having total hip replacements, with the hope of providing good pain relief combined with improved mobility after surgery.
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, Investigator)
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
- •English speaking
- •between 18 and 75 years old
- •American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total hip arthroplasty
排除标准
- •ASA 4 or 5
- •revision hip arthroplasty
- •diagnosis of chronic pain
- •daily chronic opioid use (over 3 months of continuous opioid use)
- •inability to communicate pain scores or need for analgesia
- •acute hip fracture
- •Infection at the site of block placement
- •Age under 18 years old or greater than 75 years old
- •Pregnant women
- •Intolerance/allergy to local anesthetics
- •Weight <50 kg
- •Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- •Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance
- •Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.
研究组 & 干预措施
Sham group
The same nerve block technique as above, however using an inactive solution of salt water.
干预措施: Saline (Drug)
Suprainguinal Fascia Iliaca (SIFI) block
A nerve block technique using a numbing medication called ropivacaine.
干预措施: Suprainguinal fascia iliaca (SIFI) block (Procedure)
Suprainguinal Fascia Iliaca (SIFI) block
A nerve block technique using a numbing medication called ropivacaine.
干预措施: Ropivacaine (Drug)
Sham group
The same nerve block technique as above, however using an inactive solution of salt water.
干预措施: Sham block (Procedure)
结局指标
主要结局
Numeric Pain Score at 4 Hours Postoperatively, as Measured by Numerical Rating Scale (NRS) 11
时间窗: 4 hours postoperatively
The NRS 11 ranges from 0 (no pain) to 10 (intense pain).
次要结局
- Motor Strength, as Measured by Dynamometry(4 hours postoperatively)
- Numeric Pain Score at 24 Hours, as Measured by NRS 11(24 hours)
- Cumulative Opioid Consumption(24 hours)
- Ambulation, as Measured by Distanced Walked(post-op day 0)