Efficacy of Percutaneous Electrical Neurostimulation (PENS)of the Auricle as an Opioid Sparing Postoperative Analgesic Technique in Cancer Endometrium and Cancer Cervix
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Numeric Rating Scale (NRS)
研究概览
简要总结
Pain relief following laparotomy surgery requires a variety of techniques including invasive ones like epidural or nerve blocks along with different classes of drugs, out of which opioids are most predominant. Each of these drugs have with their own set of advantages and also side effects. An ideal common system of analgesia is not possible due to patient variability. And no drug is devoid of side effects. Hence the aim is to ensure effective analgesia using drugs or techniques which are minimally invasive with negligible side effects.
详细描述
Efficient post operative pain relief is an essential part of comprehensive recovery of patients. Conventional method of pain management of laparotomy surgeries in CA endometrium and cervix patients involves invasive techniques like epidural or selective nerve block coupled with a varied choice of analgesics like opioids, NSAID or acetaminophen, wherein each drug is associated with its own set of contraindications and side effects. Despite advances in analgesic regimen including multimodal analgesic regimen, opioids have been observed to remain the mainstay postoperative analgesia in cancer patients despite its well-established side effects.
This double-blinded prospective interventional study is conducted to explore the alternative of percutaneous electrical nerve stimulation (PENS) devices for effective pain relief with minimal to no side-effects.
The device will have tiny needles and a battery system that will be placed on and behind the patient's ear when they are under anesthesia.
It acts by stimulating nerves around ear region by series of pain free impulse generation leading to centrally (brain) mediated response by altering certain chemical substances responsible for causing pain thereby providing relief for the patient.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >18 yrs
- •Diagnosed with CA-endometrium OR CA -cervix of stage I/II and post RT CA cervix patients coming for hysterectomy
- •Elective surgery
- •Informed consent obtained
- •ASA (American Society of Anaesthesiology) physical status 1-3
排除标准
- •Patient refusal
- •Cancer cervix other than the stages mentioned in inclusion criteria ASA PS >3
- •Emergency surgery, Laparoscopic and robotic procedures
- •Unplanned postoperative ventilation
- •Allergy/sensitivity to adhesive
- •Active skin infection/lesion in the ear region
- •H/O of seizure or cerebral disease
- •H/O chronic pain and prolonged analgesic usage
- •H/O opioid dependence
- •H/O anxiety or psychiatric illness requiring treatment
- •Pre-existing implantable/ electronic on demand device
- •Patients who might require MRI in the study period
- •Patients with transmissible diseases
- •Patients with coagulopathies
- •Absolute or relative contraindication to drugs used in the study
结局指标
主要结局
Numeric Rating Scale (NRS)
时间窗: 0 - 4 days; 0 hours, 2 hours, 4 hours, 8 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours. Outcomes will be reported as an average over each individual postoperative day and as an average over 5 days independently for rest.
The primary goal is to evaluate the efficacy of PENS treatment in the change in postoperative pain after cancer surgery compared to the control group. The pain is measured using the numerical rating scale (NRS). Pain Score will be measured on a scale (0 = no pain;10 = worst imaginable pain; lower scores indicate better outcome)
次要结局
- Overall Postoperative analgesia and opioid requirement(0 - 4 days, duration and dose of all prescriptions are recorded.)
- Richmond Agitation Sedation Scale (RASS)(0 - 4 days; 0 hours, 2 hours, 4 hours, 8 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours.)
- Bleeding(Time Frame: 0 - 4 days; Whenever the patient experiences bleeding.)
- Patient Ambulation(1 - 4 days; 24 hours, 36 hours, 48 hours, 72 hours, 96 hours.)
- Record of Participant Bowel Movement Patterns(0 - 4 days; Whenever the patient experiences the bowel movement.)
- Patient Discomfort(Time Frame: 0 - 4 days; Whenever the patient experiences the discomfort.)
- Interference with Daily Activities(Time Frame: 0 - 4 days; Whenever the patient experiences disruption in daily activities.)