An International, Randomised, Double Blinded, Multi-centre, Active- and Placebo-controlled Dose Response Trial to Evaluate the Efficacy and Safety of SABER-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Durect
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Pain Intensity (PI)
研究概览
简要总结
The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing elective arthroscopic shoulder surgery on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on safety.
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
- Double (Participant, Investigator)
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
- •Subacromial impingement syndrome
- •MRI with intact rotator cuff
- •Patients suitable for general anaesthesia
排除标准
- •Known major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, glenohumeral arthritis, frozen shoulder or previous surgery of the affected shoulder
- •Abnormal ECG
- •Prolonged QT syndrome
- •Current or regular use of analgesic medication for other indication(s)
研究组 & 干预措施
SABER-Bupivacaine Treatment 1a
double-blind
干预措施: SABER-Bupivacaine Treatment 1a (Drug)
Placebo SABER-Bupivacaine Treatment 1b
double-blind
干预措施: Placebo SABER-Bupivacaine Treatment 1b (Drug)
Bupivacaine HCl Treatment 1c
double-blind
干预措施: Bupivacaine HCl Treatment 1c (Drug)
SABER-Bupivacaine Treatment 2a
double-blind
干预措施: SABER-Bupivacaine Treatment 2a (Drug)
Placebo SABER-Bupivacaine Treatment 2b
double-blind
干预措施: Placebo SABER-Bupivacaine Treatment 2b (Drug)
Bupivacaine HCl Treatment 2c
double-blind
干预措施: Bupivacaine HCl Treatment 2c (Drug)
结局指标
主要结局
Pain Intensity (PI)
时间窗: 0-3 days after surgery
Mean pain intensity on movement AUC (time-normalized AUC) during the period 0-3 days after surgery. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
Supplemental Opioid Use
时间窗: 0-3 days after surgery
Cumulative IV morphine-equivalent dose of opioid rescue medication
次要结局
- Opioid Related Side Effects(0-7 days after surgery)
- Time to First Opioid Rescue Medication Usage(0-14 days after surgery)