A Phase II, Randomized, Single-dose, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Pharmacokinetic Profile of the CollaRx Bupivacaine Implant in Patients After Gastrointestinal Surgery
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- The Total Amount of Opioid Rescue Analgesia Used
研究概览
简要总结
The purpose of this study is to determine whether the CollaRx Bupivacaine Implant (bupivacaine sponge) is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after gastrointestinal (GI) surgery.
详细描述
Gastrointestinal (GI) surgery encompasses a range of surgical procedures that involve abdominal incision. Gastrointestinal surgery may be performed to treat an abdominal aortic aneurysm, ulcerative colitis, Crohn's disease, gallbladder disease, bile duct disease and morbid obesity. Although less invasive laparoscopic procedures are performed when warranted, open abdominal surgery is required for certain indications and for more complicated or advanced cases.
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 for 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 compare the amount of narcotic pain medication required after surgery in patients who receive 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be a man or woman who is ≥ 18 and ≤ 75 years of age.
- •Has a body mass index (BMI) > 19 and < 40 kg/m
- •Has a planned elective surgery that requires a vertical or transverse abdominal incision (including but not limited to abdominal aortic aneurysm repair, cholecystectomy and simple bowel resection) to be performed according to standard surgical technique under general anesthesia.
- •Has a risk classification of I, II or III according to the American Society of Anesthesiologists (ASA)
- •If female, is nonpregnant (negative pregnancy test at Screening and Day 0 before surgery) and nonlactating.
- •If female, is either not of childbearing potential or practicing a defined medically acceptable method of birth control and agrees to continue with the regimen throughout the study.
- •Is free of other physical or mental conditions that, in the opinion of the Investigator, may confound quantification of postoperative pain resulting from the surgery.
- •Has the ability and willingness to comply with the study procedures and the use of the pain scales; is deemed capable of operating a PCA device; and is able to communicate meaningfully with the study staff.
- •Must voluntarily sign and date an informed consent form (ICF) that is approved by an IRB prior to the conduct of any study specific procedures.
- •Must be able to fluently speak and understand English and be able to provide meaningful written informed consent for the study.
排除标准
- •Has known hypersensitivity to amide local anesthetics, opioids or bovine products, or to inactive ingredients of the test article.
- •Has 1 of the following surgical procedures planned: total abdominal hysterectomy, omentectomy or surgical procedure for staging cancer.
- •Requires the use of Seprafilm® or other absorbable adhesion barriers for the GI surgery.
- •Requires any additional surgical procedures either related or unrelated to the GI surgery during the same hospitalization.
- •Is required to receive neuraxial (spinal or epidural) opioid analgesics during the study.
- •Has cardiac arrhythmia or atrioventricular (AV) conduction disorders.
- •Concomitantly uses antiarrhythmics (eg, amiodarone), propranolol or strong/moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide antibiotics and grapefruit juice).
- •Has 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.
- •Has used aspirin or aspirin containing products within 7 days of surgery. Aspirin at a dose of ≤ 325 mg is allowed for cardiovascular prophylaxis if the patient has been on a stable dose regimen for ≥ 30 days prior to Screening.
- •Has undergone another major surgery within 3 months of the GI surgery.
- •Has known or suspected history of alcohol or drug abuse or misuse within 3 years of Screening or evidence of tolerance or physical dependency on opioid analgesics or sedative hypnotic medications.
研究组 & 干预措施
1
Either three or four 5x5-cm bupivacaine sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.
干预措施: Bupivacaine Collagen Sponge (Drug)
2
Either three or four 5x5-cm placebo sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.
干预措施: Placebo (Drug)
结局指标
主要结局
The Total Amount of Opioid Rescue Analgesia Used
时间窗: 0 to 24 hours postoperatively
Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
次要结局
- The Total Amount of Opioid Rescue Analgesia Used(0 to 72 hours postoperatively)
- Pain Intensity Rating on the Visual Analogue Scale (VAS)(1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours after Time 0)
- Pain Intensity Rating on a 4-point Scale(At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours postoperatively)
- Pain Relief Rating on a 5-point Scale(At 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours after Time 0)
- Patient Global Evaluation of Study Treatment on a 5-point Scale(At 72 hours after time 0)
- Time to First Use of Opioid Rescue Analgesia(actual time from time 0)
- Pharmacokinetic Parameters(30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48 and 72 hours postoperatively)
- The Incidence of Treatment-emergent Adverse Events(Through 30 days after surgery)
- Changes in Vital Sign Measurements(Through 72 hours post insertion)