Use of Transcutaneous Electrical Nerve Stimulation Device, Reletex Reliefband to Decrease Postoperative Nausea and Vomiting in the Bariatric Surgical Patient
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Post operative nausea and vomiting (PONV) incidents utilizing the PONV impact scale in placebo/sham vs active group.
研究概览
简要总结
The goal of this clinical trial is to learn if the Reletex Reliefband device when used in conjunction with our current treatments will further decrease postoperative nausea and vomiting. The Investigators want to test how well it works, specifically in bariatric surgery patients that are at a higher risk for nausea and vomiting after surgery. Furthermore, the investigators would like to see if using this non-drug treatment option might allow for the same or better control of nausea and vomiting with fewer side effects than the current medications used. This may decrease drowsiness, and allow for earlier mobility, increase comfort, and generally accelerate recovery after surgery.
The main questions it aims to answer are:
- Does the use of Reletex Reliefband decrease postoperative nausea and vomiting (PONV) in the Bariatric surgical patient, therefore decreasing need for additional anti-emetics.
- Does the use of Reletex Reliefband the use of the Reletex Reliefband during the immediate post-operative period reduce PONV, allowing for early mobility, decreased pain and length of stay (LOS).
- Does the use of Reletex Reliefband decrease the use of medications for nausea and therefore decrease costs.
- Does the use of Reletex Reliefband reduce prolonged PONV and therefore prevent the downstream effects, i.e. less mobility, increased pain, inhibit the patients' ability to comply with recommended treatments.
- If reducing PONV using non-pharmaceutical approaches will improve outcomes and patient experiences.
Researchers will compare to a placebo (a look-alike device) to see if the Reletex Reliefband works to decrease PONV.
Participants will:
- All receive the standard Enhanced Recovery After Surgery (ERAS) Protocol before, during and after surgery. (This includes use of premedications for pain, and nausea)
- Have a band applied and turned on at the completion of the patient's bariatric sleeve surgery. The band will be adjusted based on need and worn for a total of 24 hours postoperatively.
- Have a pedometer clipped to their gown, to remain in place for 24 hours postoperatively
- Be assessed regularly during their hospital stay by the nurses to monitor the site of the band, their level of nausea/vomiting, pain levels, and level of mobility
详细描述
Procedures:
Recruitment:
To prevent any potential undue influence that may inadvertently occur due to patient physician or patient coordinator relationships the investigators have decided that the bariatric fellow who has limited exposure to the patients in the office setting or in the lead up to surgery, would be less likely to elicit this response. At the patient's final pre-operative visit in the office prior to surgery the fellow will meet privately with the patients He will discuss the device, utilizing educational materials and a video provided by the device company and then explain the study to the patient, allowing time for questions and reassuring them that care will be provided for PONV, regardless of participation in the study. He will then obtain consent.
Application of band:
Reletex Band will be applied and turned on to setting #1 at completion of the participant's bariatric sleeve surgery. Assessments will be done utilizing the Post Operative Nausea and Vomiting (PONV) Impact Scale and the band settings will be titrated per the protocol at hr 1and 2 in Post Anesthesia Care Unit (PACU).
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)
盲法说明
The double-blind randomization of the devices, actual or sham/placebo will be controlled by the device manufacturer, so the clinicians involved in direct patient care will not be biased, and the documentation/data collection will remain unbiased
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
- •Adults 18-75 years of age
- •BMI 35 or greater
- •Patients eligible for and undergoing a Robotic Sleeve Gastrectomy
- •Able to consent on own behalf
排除标准
- •A diagnosis of gastroparesis
- •Pregnancy
- •Presence of a cardiac pacemaker/defibrillator or intrathecal pump
- •Current smoker or tobacco use within 30 days of procedure.
- •Known allergic reactions to conductivity gel.
- •Due to the nature of the Robotic Sleeve Gastrectomy patients who may be unable to follow or comprehend the long-term restrictions and/or requirements inherent of the surgery due to altered mentation are excluded from having the surgery.
研究组 & 干预措施
Arm 1, will receive the placebo or sham device.
The sham device will mimic the actual device by looks, and feeling, but won't actually emit a low-level electric current to stimulate the nerves.
干预措施: A sham device that will mimic the active wearable device. It will look the same, and buzz but will not actually admit a low-leve electric current that would stimulate the nerves. (Device)
Arm 2- will receive active band
This is the actual device, so it will emit a low-level electric current and stimulate the nerves of the patient.
干预措施: Wearable Transcutaneous electrical Nerve Stimulation unit to mitigate postoperative nausea and vomiting (PONV) in the Bariatric Surgical Patient (Device)
结局指标
主要结局
Post operative nausea and vomiting (PONV) incidents utilizing the PONV impact scale in placebo/sham vs active group.
时间窗: This will be assessed over the first 24 hours postoperatively.
Evaluate the effectiveness of utilizing the Reletex Reliefband to decrease incidence of postoperative nausea and vomiting (PONV). This would be measured using the PONV impact scale and taking an average of this throughout the 24 hour period for all participants. Our end point goal would be that those with the active device would have an average PONV score of \<5 indicating minimal PONV.
次要结局
- Participants w/active wearable device to prevent PONV will have a reduced need for additional anti-emetics. This will be measured by looking at the average number of anti-emetics given as needed for the first 24 hours in both arms.(24 hours postoperatively)
研究者
Yelizaveta Dobruskin
Medical Director Bariatric Surgery & Metabolic Medicine
Penn Medicine Princeton Health