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临床试验/NCT03750357
NCT03750357已完成不适用

Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Acute Pain Management Post Cardiac Surgery

DyAnsys, Inc.2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年10月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
DyAnsys, Inc.
入组人数
60
试验地点
2
主要终点
PAIN Relief by physical examination by HCP

研究概览

简要总结

Percutaneous Electrical Nerve Stimulation (PENS) of the auricle for acute pain management post cardiac surgery

详细描述

A well formulated analgesic protocol is fundamental to fast tracking post cardiac surgery. Traditional analgesic methods have their own set of drawbacks unique to cardiac surgery. Opioids have well established side effects like nausea, vomiting, respiratory depression, urinary retention. Regional anesthetic techniques in anti coagulated patients may result in potentially catastrophic neurological, bleeding and thromboembolic sequelae. Non steroidal Anti Inflammatory Drugs (NSAIDs) have been associated with increased cerebrovascular events, renal dysfunction, sternal wound infections. These make alternative therapies, including non pharmacological modalities, attractive options for optimal analgesic therapy during the post operative period.

Alternative methods like topical application of COX -2 inhibitors, intravenous magnesium, Transcutaneous Electrical Nerve Stimulation (TENS) have been tried with varied results in cardiac surgery. A somatotopic relationship has been described between the auricle and the other anatomical regions of the body. When specific points are accurately identified along the meridians of the ear and stimulated electrically, analgesic effects are known to occur. Percutaneous Electrical Nerve Stimulation (PENS) of the auricle and its efficacy in management of post midline sternotomy pain has not been evaluated previously. Primary Relief v 2.0 is a device which provides continuous PENS aimed at non pharmacological post operative pain management.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cardiac surgery patient with midline sternotomy incision

排除标准

  • Thoracotomy incisions
  • Patients with pacemakers,
  • Post operative cognitive dysfunction
  • Anticipated ventilation > 24 hrs
  • Pre operative opioid therapy
  • Ear infections
  • Skin lesions / allergy to adhesive materials
  • Re-exploration for any reason

研究组 & 干预措施

Only Paracetamol

No Intervention

Group B will be treated with paracetamol drug.

Primary Relief v 2.0 with Paracetamol

Experimental

Group A will be treated with Primary Relief v 2.0(1 - 100Hz) sweep stimulation with increase in power of the stimulation for fixed interval of time.

干预措施: Primary Relief v 2.0 (Device)

结局指标

主要结局

PAIN Relief by physical examination by HCP

时间窗: After 2 hours of device activation

Relief of pain when the dosage of the anesthesia level gradually decreases after the surgery completion. This is measured by physical interaction with the patient by the health care provider.

次要结局

未报告次要终点

研究者

发起方
DyAnsys, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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