Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Numeric Rating Scale Pain Scores at Post-operative Day 14
研究概览
简要总结
This study aims to identify the timeline of pain following total shoulder replacement with the goal of developing data for a subsequent randomized trial. The investigators believe that with using HSS's current protocol, many patients have postoperative pain that is no worse than their preoperative pain. Previous HSS anesthesia protocols for total shoulder arthroplasty patients have not formally followed patients past their hospital discharge, and the investigators believe that some patients do experience moderate to severe subacute postoperative pain. Therefore, this study's primary outcome is to look at the numeric pain scores at 14 days after surgery. Future studies will look at measures of preventing bruising and subsequent pain after shoulder replacement.
详细描述
This is a pilot study, with the goals of
- developing data for a subsequent randomized trials
- describing the pain trajectory after total shoulder arthroplasty given comprehensive multimodal perioperative analgesia
- gathering preliminary data about which shoulder arthroplasty patients are at high risk for moderate or severe postoperative pain (NRS with movement, POD14, moderate >= 4- 6; Gerbershagen 2011; severe >= 7-10, Krebs 2007) Potential factors include fibromyalgia score, catastrophizing score, anxiety/depression score, gender, preoperative opioid use
- gathering preliminary data on the potential association between the predictors listed in (c) and NRS pain score with movement on POD 14.
- estimating incidence and severity of postoperative bruising on POD 14
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •All patients eligible for the standardized anesthetic for TSA
- •Patients who are capable to provide informed consent and answer questions in English (Study involves questionnaires validated in English)
- •Age 18-80
排除标准
- •Incapable to provide informed consent
- •Contraindications for regional anesthesia (anticoagulation, infection at injection site)
- •Patients undergoing TSA for Trauma or Rheumatoid Arthritis
- •Revision TSA (previous non-TSA surgery is not an exclusion)
- •Conversion of hemiarthroplasty to TSA
- •Planned use of tranexamic acid
结局指标
主要结局
Numeric Rating Scale Pain Scores at Post-operative Day 14
时间窗: 14 days after surgery for each patient
Quantifying patients' pain at a sub-acute time point after surgery at rest and with movement. The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
次要结局
- Opioid Related Symptom Distress Scale(Day 1 after surgery)
- Range of Motion(Day 14 after surgery and 3 months after surgery)
- Severity of Bruising(Day 14 after surgery)
- Hospital Anxiety and Depression Scale(Day 1 after surgery)
- PainOUT Questionnaire(Day 1 and 14 after surgery)
- Fibromyalgia Scale. a Lower Score is a Better Outcome.(Day of Surgery)
- Numeric Rating Scale (NRS) Pain With Movement and at Rest.(Days 1 day (POD0), 3 days(POD3), 7 days(POD7) and 3 months(POD90) after surgery)
- Opioid Consumption (in Past 24 Hours)(Days 1 day, 3 days, 7 days after surgery)
- Pain Catastrophizing Scale (PCS)(Day of Surgery)