A Double-Blind, Multi-Center, Placebo-Controlled Trial of SABER-Bupivacaine for Post-Operative Pain Control and Opioid Sparing/Opioid-Related Adverse Event Reduction 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
- 60
- 主要终点
- Mean Pain Intensity on Movement AUC (Time Normalized Area Under the Curve) During the Period 0 to 72 Hours Post-dose.
研究概览
简要总结
This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain.
The purpose of this study is to investigate safety (if there are any side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following shoulder surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be able to read and understand the consent form, provide written consent, complete trial-related procedures, and communicate with the trial staff.
- •Males and females, 18 to 65 years of age, scheduled for shoulder surgery.
- •Patients must be healthy or have only mild systemic disease.
- •Patients must have ECG wave form within normal limits
- •Patients must have blood pressure within normal range.
- •Male and female patients must agree to use medically acceptable method of contraception throughout the entire trial period and for 1 week after the trial is completed.
- •Patients must refrain from strenuous activities and avoid changes to prescribed exercise levels throughout the course of the trial.
排除标准
- •Patients with previous arthroscopic surgery or open surgery on the study shoulder.
- •Patients with chronic pain conditions requiring continuous use of corticosteroids for greater than 3 months.
- •Patients with fibromyalgia, rheumatoid arthritis, and/or sero-negative inflammatory arthropathies.
- •Patients with a below normal calculated creatinine clearance.
- •Patients who are pregnant or lactating.
- •Patients currently receiving more than 20 mg of hydrocodone daily (or equivalent narcotic dose) on routine basis.
- •Patients, who in the Investigator's opinion, have developed opioid tolerance.
- •Patients with current or regular use of anticonvulsants, antiepileptics, antidepressants, or monoamine oxidase inhibitors at screening.
- •Patients with current or regular use of drugs known to significantly prolong the corrected QT interval
- •Patients with known hypersensitivity to local anesthetic agents of the amide type (e.g., lidocaine, bupivacaine).
- •Patients with known hypersensitivity to opioids.
- •Patients with conditions contraindicated for use of opioids.
- •Patients with known or suspected abuse of opioids or other illicit drugs.
- •Patients with known or suspected alcohol abuse.
- •Participation in another clinical trial at the same time or within 30 days of this trial.
- •Patients who, in the Investigator's opinion, should not participate in the trial or may not be capable of following the trial schedule for any reason.
研究组 & 干预措施
Group 2: SABER-Placebo
5.0 mL SABER-Placebo/Once
干预措施: SABER-Placebo (Drug)
Group 1: SABER-Bupivacaine
5.0 mL SABER-Bupivacaine/Once
干预措施: SABER-Bupivacaine (Drug)
结局指标
主要结局
Mean Pain Intensity on Movement AUC (Time Normalized Area Under the Curve) During the Period 0 to 72 Hours Post-dose.
时间窗: 0 to 72 hours post-dose
Mean pain intensity on movement AUC (time normalized area under the curve) during the period 0 to 72 hours post-dose. Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The pain intensity AUC on movement was computed for each subject using the standard trapezoidal rule. For the purpose of better clinical interpretability of the pain AUC, a normalized AUC was computed by dividing it using the time-interval length over which it was computed.
Supplemental Opioid Use
时间窗: 0 to 72 hours post-dose
Mean total morphine-equivalent dose during the period 0 to 72 hours post-dose
次要结局
- Time-to-first Use of Opioid Supplemental Pain Medication(0 to 14 days post-dose)
- Number (Frequency) of Participants Reporting Opioid-related Adverse Events(0 to 72 hours post-dose)
- Supplemental Opioid Use(0 to 48 hours post-dose)
- Severity of Opioid-related Side Effects(0 to 14 days post-dose)
- Mean Pain Intensity on Movement AUC (Time-normalized AUC) During the Period 0 to 48 Hours Post-dose (0 to 2 Days Post-dose).(0 to 48 hours post-dose)