A Randomized Controlled Trial Comparing a Periarticular Injection to a Popliteal Block for Pain Control in Ankle/Hindfoot Osteotomy or Fusion and Ankle Fractures
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual Analog Score
研究概览
简要总结
This study aims to determine the effectiveness and safety of two standard of care perioperative procedures for controlling pain following ankle and hindfoot osteotomy or fusion or ankle fracture repair.
详细描述
This is a prospective, randomized, controlled research study of two perioperative standards of care for managing post operative pain. The first standard of care procedure is the periarticular injection; the second is the popiteal block.
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
- 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
- 否
入选标准
- •Ankle or hindfoot osteotomy or ankle fracture repair
- •Surgery scheduled at Campbell Surgery Center (1410 Brierbrook Road, Germantown, TN 38138)
- •18-80 years of age
- •ASA I-III with medical clearances as needed
- •Fluent ub verbal and written English
- •Willing and able to comply with study instruction and commit to all follow-up visits for theduration of the study
- •Willing and able to provide written consent
排除标准
- •Diagnosed with chronic pain syndrome
- •History of allergic reactions to lidocaine, marcaine, Experal, bupivicaine, or other injectable anesthetic agents
- •Injury associated with workers' compensation
- •Surgery to be performed at a hospital
- •Diagnosed with peripheral neuropathy
- •Hbg A1C is > 7 mg/dl in diabetic patients only
- •Long term (chronic) preoperative narcotic usage
研究组 & 干预措施
Popliteal Block
Subjects undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair will recieve a popliteal block by the anesthesiologist using 30 milliliters of bupivicaine 0.5 percent in the pre-operative area, prior to surgery, using an ultrasound machine for guidance.
干预措施: Bupivicaine (Drug)
Periarticular Injection
Subjects undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair will recieve a periarticular injection by the surgeon using 10 milliliters of Exparel mixed with 10 milliliters of bupivicaine 0.5 percent at the end of the procedure.
干预措施: Exparel (Drug)
结局指标
主要结局
Visual Analog Score
时间窗: Postoperative week 12
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
Evidence of motor block
时间窗: Postoperative hour 3
Patient reported yes/no answer to survey question: "Are you able to wiggle your toes?"
次要结局
- Document pain medication prescribed immediately after surgery(Immediately after surgery)
- Neuralgia symptoms: survey question(Postoperative week 12)
- Pill count(Postoperative week 12)
- Document pain medication prescribed at postoperative week 2(Postoperative week 2)
- Document pain medication prescribed at postoperative week 6(Postoperative week 6)
- Satisfaction with pain control: survey question(Postoperative week 12)
- Document pain medication prescribed at postoperative week 12(Postoperative week 12)