Psoas Compartment Block Versus Periarticular Local Anesthetic Infiltration for Pain Management for Total Hip Arthroplasty: A Prospective, Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain Score at 3 Hours
研究概览
简要总结
The primary objective of this study is to examine whether there is a difference in the level of resting pain following total hip arthroplasty with an anterior approach with use of a psoas compartment block versus a local periarticular anesthetic infiltration
详细描述
A single-center, prospective, randomized clinical trial with a total of 100 patients. One orthopaedic adult reconstruction surgeon at Beaumont Hospital Royal Oak (JJV) will perform all surgeries. After the patient has consented they will be randomized to one of the following two groups:
- Psoas compartment block (n=50)
- Periarticular local anesthetic infiltration (n=50),
The patient will be blinded to the study group.
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
- Single (Participant)
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
- •Patients undergoing unilateral primary total hip arthroplasty by Dr. James Verner at Beaumont Hospital Royal Oak
- •Have a diagnosis of primary osteoarthritis (i.e. degenerative joint disease)
- •Surgical approach is anterior
排除标准
- •Minors (age less than 18 years)
- •Pregnant (surgically sterile, post-menopausal, or negative blood test)
- •Previous ipsilateral hip surgery
- •Lumbar instrumentation
- •Acute trauma
- •Rheumatoid arthritis
- •Avascular necrosis
- •Hip dysplasia
- •Known sensitivity, allergy, or contraindication to anesthetics being used in the study
- •Narcotic sensitivity
- •History of over 6 months of opioid dependency prior to surgery (excluding tramadol)
- •Peripheral neuropathy
- •Mental/cognitive impairment that would interfere with the patient's self-assessments of function, pain, or quality of life
研究组 & 干预措施
Periarticular Local Anesthetic
An anesthetic "cocktail" of four drugs (ropivacaine, epinephrine, ketorolac tromethamine, morphine) is injected at five locations at the surgical site to the surrounding tissues.
干预措施: Epinephrine (Drug)
Psoas Compartment Block
After exposure anesthetic (Ropivacaine with NaCl) is introduced directly into the iliopsoas muscle, where it then spreads to the lumbar plexus (the nerves responsible for sensation around the surgical site).
干预措施: Ropivacaine with NaCl (Drug)
Periarticular Local Anesthetic
An anesthetic "cocktail" of four drugs (ropivacaine, epinephrine, ketorolac tromethamine, morphine) is injected at five locations at the surgical site to the surrounding tissues.
干预措施: Morphine (Drug)
Periarticular Local Anesthetic
An anesthetic "cocktail" of four drugs (ropivacaine, epinephrine, ketorolac tromethamine, morphine) is injected at five locations at the surgical site to the surrounding tissues.
干预措施: Ketorolac Tromethamine (Drug)
Periarticular Local Anesthetic
An anesthetic "cocktail" of four drugs (ropivacaine, epinephrine, ketorolac tromethamine, morphine) is injected at five locations at the surgical site to the surrounding tissues.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Pain Score at 3 Hours
时间窗: 3 hours postoperative
Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
次要结局
- Pain Score at 3-24 Hours(measured once during time frame 3 hours-24 hours postoperative)
- Pain Score at 24-48 Hours(measured once during time froma 24-48 hours postoperative)
- Opioid Usage In-hospital at 24 Hours(24 hours postoperatively)
- Opioid Usage In-hospital at 48 Hours(48 hours postoperatively)
研究者
James Verner
MD
William Beaumont Hospitals