A Phase II, Single-dose, Open-label Study to Investigate the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant (200 mg Bupivacaine Hydrochloride) in Men After Laparoscopic Inguinal or Umbilical Herniorrhaphy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Total Use of Opioid Analgesia - Morphine Equivalence (mg)
研究概览
简要总结
This study will assess pain intensity for the first 72 hrs after aggravated movement (cough) following Laparoscopic Inguinal or Umbilical Herniorrhaphy.
详细描述
Inguinal herniorrhaphy is a common surgery; approximately 2,800 per million people in the United States (US) undergo the procedure annually.Common surgical methods of herniorrhaphy include open and laparoscopic placement of synthetic mesh. Studies have shown that the use of synthetic mesh greatly reduces the risk of hernia recurrence regardless of the method used for its placement. Furthermore, utilizing the laparoscopic approach for umbilical hernia repair, specifically with the use of mesh, may also reduce the risk of infection.
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 open-label study will assess pain intensity after surgery in patients who receive the CollaRx Bupivacaine implant as well as determine the feasibility of the use of the laparoscope for sponge placement in laparoscopic hernia repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Has a planned unilateral inguinal herniorrhaphy (laparoscopy, transabdominal preperitoneal [TAPP] approach or totally extraperitoneal [TEP] approach) or laparoscopic umbilical herniorrhaphy to be performed according to standard surgical technique under general anesthesia.
- •Willing to use opioid rescue analgesia.
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 at the location scheduled for repair.
- •Undergone major surgery within 3 months of the scheduled herniorrhaphy.
研究组 & 干预措施
Drug: Bupivacaine Collagen Sponge
bupivacaine collagen sponges
干预措施: 5x5cm bupivacaine collagen sponges (Drug)
结局指标
主要结局
Total Use of Opioid Analgesia - Morphine Equivalence (mg)
时间窗: 0 to 24 hours after surgery
Dosages of 1 to 2 mg per dose were titrated to patient comfort according to institutional standards and at the investigator's discretion. Once patients could tolerate oral medication, they were offered oral morphine (15 mg tablets) as rescue analgesia if necessary. The dose for patients who weighed less than 75kg was 15mg every 3 to 4 hours as needed for pain control. The dose for patients who weighed 75kg or more was 1-2 tablets (15-30 mg) every 3-4 hours for pain control. Morphine was the preferred rescue medication.
Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg)
时间窗: 0-72 hours
Dosages of 1 to 2 mg per dose were titrated to patient comfort according to institutional standards and at the investigator's discretion. Once patients could tolerate oral medication, they were offered oral morphine (15 mg tablets) as rescue analgesia if necessary. The dose for patients who weighed less than 75kg was 15mg every 3 to 4 hours as needed for pain control. The dose for patients who weighed 75kg or more was 1-2 tablets (15-30 mg) every 3-4 hours for pain control. Morphine was the preferred rescue medication.
Total Use of Opioid Rescue Analgesia Morphine Equivalence (mg)
时间窗: 0-48 hours)
Dosages of 1 to 2 mg per dose were titrated to patient comfort according to institutional standards and at the investigator's discretion. Once patients could tolerate oral medication, they were offered oral morphine (15 mg tablets) as rescue analgesia if necessary. The dose for patients who weighed less than 75kg was 15mg every 3 to 4 hours as needed for pain control. The dose for patients who weighed 75kg or more was 1-2 tablets (15-30 mg) every 3-4 hours for pain control. Morphine was the preferred rescue medication.
次要结局
未报告次要终点