A Phase II, Randomized, Single Dose, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety Profile of the CollaRx® Bupivacaine Implant (200 mg Bupivacaine Hydrochloride) in Men After Open Laparotomy Herniorrhaphy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Sum of Pain Intensity Defined as Area Under the Curve (AUC) of 100-mm VAS PI Scores.
研究概览
简要总结
This study will assess pain intensity for the first 72 hrs after after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.
详细描述
Inguinal herniorrhaphy is a common surgery; and common surgical methods used include laparoscopic and open placement of synthetic mesh. The use of synthetic mesh can greatly reduce the risk of hernia recurrence regardless of the method used for its placement. Managing postoperative pain and preventing morbidity after open mesh herniorrhaphy remain considerable medical challenges.
Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery.
This study will assess pain intensity after surgery in patients who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Man ≥ 18 years
- •Body mass index (BMI) ≥ 19 and ≤ 40 kg/m
- •Has a planned unilateral inguinal herniorrhaphy (open laparotomy, tension free technique) to be performed according to standard surgical technique under general anesthesia.
排除标准
- •Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products.
- •Scheduled for bilateral inguinal herniorrhaphy.
- •Undergone a prior herniorrhaphy on the side scheduled for repair.
- •Undergone major surgery within 3 mos of the scheduled herniorrhaphy.
- •Has cardiac arrhythmias or atrioventricular (AV) conduction disorders.
- •Concomitantly uses antiarrhythmics (eg, amiodarone, lidocaine), propranolol, or strong/moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide antibiotics and grapefruit juice).
- •Used long acting analgesics within 24 hours of surgery. Short acting analgesics such as acetaminophen may be used on the day of surgery but are subject to preoperative restrictions for oral intake.
研究组 & 干预措施
2, Placebo collagen sponges
Placebo collagen sponges
干预措施: Placebo collagen Sponge (Drug)
2, 5x5cm bupivacaine collagen sponges
collagen sponges
干预措施: Bupivacaine Collagen Sponge (Drug)
结局指标
主要结局
Sum of Pain Intensity Defined as Area Under the Curve (AUC) of 100-mm VAS PI Scores.
时间窗: 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.
The primary efficacy variable was SPI defined as area under the curve (AUC) of 100-mm VAS pain intensity scores after aggravated movement (cough) from 1 to 72 hours after surgery. Minimum score is "0". Maximum score is 7200. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. A lower score means a better outcome or less pain reported.
次要结局
- Sum of Pain Intensity (SPI) After Aggravated Movement (Cough)(1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.)
- Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest(1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.)
- Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough)(1,2,4,6,8,10,12,24,48 and 72 hours)
- Pain Intensity VAS Scores Over Time at Rest(1,2,4,6,8,10,12,24,48 and 72 hours)
- Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement(1,2,4,6,8,10,12,24,48 and 72 hours)