Carolina's Opioid Reduction Effort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 511
- 试验地点
- 1
- 主要终点
- Pain at 24 hours postop
研究概览
简要总结
To compare the safety and effectiveness of two pain control pathways following routine orthopaedic surgical procedures (single level or two-level ACDF/ACDA, 1st CMC arthroplasty, Hallux Valgus/Rigidus corrections, diagnostic knee arthroscopies, total hip arthroplasty, and total shoulder arthroplasty / reverse total shoulder arthroplasty). The control group will undergo surgery with an opioid-based pain protocol and the intervention group will undergo surgery with a multimodal, opioid-free protocol.
Patients will have data collected with respect to pain scores, overall comfort level, overall satisfaction with the surgical experience and recovery, constipation, falls, and overall satisfaction with pain control, in addition to procedure-specific outcome scores and patient-specific metrics.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Opioid
The opioid-based arm utilizes traditional, standard-of-care treatment for each applicable surgery. The medications (including dosage and frequency) used in this arm vary depending on the surgery being performed; however, tend to include medications in the opioid family such as Hydromorphone, Hydrocodone, Tramadol, or Oxycodone.
干预措施: Opioids (Drug)
Opioid-Free
The opioid-free arm utilizes medications that do not belong to the opioid family of medications. All medications used are FDA-approved and no experimental medications are being used. The medications (including dosage and frequency) used in this arm vary depending on the surgery being performed; however, tend to include medications such as Gabapentin, Tylenol, Meloxicam, Bupivacaine, or Ketorolac.
干预措施: Opioid-Free (Drug)
结局指标
主要结局
Pain at 24 hours postop
时间窗: 24 hours
Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score
次要结局
- Pain at 1 year postop(1 year)
- General Health(1 year)
- Pain at 12 hours postop(12 hours)
- Pain at 2 weeks postop(2 weeks)
- Pain at 6 weeks postop(6 weeks)
- Pain at 6 hours postop(6 hours)