Continuous Preperitoneal Infusion of Local Anesthetic Via Pain Pump for Laparoscopic Ventral Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Post-Operative Pain
研究概览
简要总结
The primary endpoint of this study will determine if subjects receiving a continuous infusion of local anesthetic following laparoscopic ventral hernia repair, with the pain pump installed as described to treat post surgical pain will have a lower incidence of pain than those patients treated with a placebo, saline-filled pain pump.The secondary endpoint of this study will determine if subjects receiving a continuous infusion of local anesthetic following laparoscopic ventral hernia repair, with the pain pump installed as described to treat post surgical pain will have a lower utilization of narcotic analgesic medication than those patients treated with the placebo, saline-filled pain pump.
详细描述
Patients will be screened to determine study eligibility using inclusion/exclusion criteria. Following the consent process, subjects will be randomly assigned to a treatment arm (anesthetic or placebo group). Baseline data will be collected prior surgical implantation of the pain pump delivery system. Both study and control groups will be able to receive supplemental medication for breakthrough pain as determined by the surgeon. Post-operative data will be collected up to three weeks following 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I,II,III
- •Scheduled for Laparoscopic Ventral Hernia Repair
排除标准
- •ASA IV or greater
- •Needing emergency surgery
- •Known history of drug abuse
- •GI, liver, kidney or other condition which, per the surgeon's opinion, could interfere with the absorption, distribution, metabolism or excretion of any drug used during the duration of the study
- •Patients with a prior allergic reaction or dependency to morphine, demerol, dilaudid, fentanyl, marcaine(bupivicaine), lidocaine, or ropivicaine.
结局指标
主要结局
Post-Operative Pain
时间窗: Verbal Rating Scale used twice a day, up to 7 days postoperatively
Patients will self-report pain assessments on questionnaires each of the first seven days post-operatively using the 4 Point Verbal Rating Scale; ranging from 1=Severe Pain, to 4=No Pain, higher scores indicating less pain, or a better outcome. Values for two daily scores were averaged for each participant, the average across 7 days is reported.
次要结局
- Number of Days With Post-Operative Narcotic Analgesic Use(Up to 3 weeks post surgery)
研究者
Michael Ujiki MD
Director of Minimally Invasive Surgery
NorthShore University HealthSystem