Prospective Randomized Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Post-operative Pain After Direct Anterior Total Hip Replacement
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Changes in pain score
研究概览
简要总结
To compare two methods of post-operative pain management in patients undergoing total hip arthroplasty. There is a perception that the periarticular injections may not be as effective in controlling post-operative pain.
Both methods are current standard of care. The investigators want to compare the outcomes of each when patients are randomized to one of the methods compared to the other method of post-operative pain control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- 是
入选标准
- •Subject scheduled for Direct Anterior unilateral total hip replacement
- •Weight ≥ 50 and ≤125 kg
- •Intact neurological exam
- •Cognitively intact with ability to sign consent
排除标准
- •Renal insufficiency with creatinine > 1.5 mg/dl
- •Allergic to any of the following : Ropivacaine, Epinephrine, Ketorolac, Morphine sulfate, NSAIDs, Tylenol, Neurontin, Morphine, Oxycodone or Dilaudid.
- •Subject taking regular narcotic medications prior to surgery (20mg/day Morphine equivalents for >7days)
- •Subject with prior open hip surgery who received regional anesthesia or periarticular injection for post op pain management.
- •Subject with contraindication for spinal anesthesia
研究组 & 干预措施
L2 paravertebral block
regional anesthetic nerve blocks using an L2 paravertebral block with ropivacaine
干预措施: L2 paravertebral block (Other)
periarticular injection group
periarticular local injection into the periarticular soft tissues at the time of hip replacement using a combination of ropivacaine, epinephrine, ketorolac and morphine sulphate (periarticular injection group).
干预措施: periarticular injection group (Other)
结局指标
主要结局
Changes in pain score
时间窗: post-operative to 7 days
Static and dynamic post-operative pain scores, measured on a 1 - 10 visual analogue scale.
次要结局
未报告次要终点
研究者
John M. Redmond, M.D.
Orthopedic Consultant
Mayo Clinic