Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) Using the BRIDGE Device for Post-Operative Pain Control in Patients Undergoing Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)
研究概览
简要总结
Auricular neurostimulation is a potential novel and non-invasive method of pain control following liver transplantation in a growing patient population with the probability of significant impact on economics and morbidity. The investigators propose a pilot study to investigate the effects of auricular neurostimulation in patients receiving a liver transplantation. The investigator will investigate the effects of auricular neurostimulation with this novel device and compare it to the current standard of care for pain management following liver transplantation.
详细描述
This is a prospective, randomized study to determine the efficacy of the BRIDGE device in reducing pain and opioid use in patients following liver transplantation. Subjects will be randomized in a 1:1 ration to one of the below groups:
Group 1: BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia
Group 2: Subjects will receive the standard of care pain control analgesia
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •≥18 years of age but <70 years of age
- •Actively listed for isolated liver transplantation
- •Subject or legally authorized representative able to sign informed consent
- •Not currently treated with opioids or any medications that may interact with opioids
- •English speaking
- •Willing and able to participate and consent to this study
排除标准
- •Diagnosis of acute liver failure or primary sclerosing cholangitis (PSC)
- •Anticipated that the subject will require a new roux-en-y hepaticojejunostomy
- •Current use of opioid use or other substance abuse.
- •Chronic pain disorders
- •Need for regional anesthesia (regional nerve blocks or epidurals)
- •Adhesive allergy/sensitivity
- •Subject admitted to the ICU at the time of transplant
研究组 & 干预措施
Group 1
BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia
干预措施: BRIDGE device (Device)
Group 2
Subjects will receive the standard of care pain control analgesia
结局指标
主要结局
Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)
时间窗: up to day 30
Comparison between study groups (BRIDGE device vs. Standard of Care)
次要结局
- Incidence of Post-operative Ileus Will be Measured by Need for Nasogastric Decompression for >48 Hours(up to 30 days)
- Reduction in Time for Return of Bowel Function as Measured by Length to Time of Bowel Functioning Return.(up to day 30)
- Improved Post-operative Mobility as Measured by the Patient Symptom Surveys(up to 30 days)
- Reduction in Length of Hospital Stay as Measured by Days in Hospital(up to 30 days)
- Pain Level(up to day 30)
- Reduction in Nausea Scores as Measured by a 4-item Questionnaire Response(up to day 30)
- Reduction in Vomiting Scores as Measured by a 4-item Questionnaire Response(up to day 30)