EFFICACY OF PERCUTANEOUS ELECTRICAL NEUROSTIMUATION (PENS) OF THE AURICLE AS AN OPIOID SPARING POSTOPERATIVE ANALGESIC TECHNIQUE IN CANCER ENDOMETRIUM AND CANCER CERVIX PATIENTS
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Reduction in postoperative pain scores as measured by NRS pain scale between 0-10
研究概览
简要总结
This study aims to test the efficacy of PENS device (-a minimally invasive neurostimulation device which acts by stimulating the nerves around the auricle percutaneously) in decreasing pain scores in cancer endometrium / cervix patients after their elective laparotomy surgeries as the primary outcome.
Adequate post operative pain relief through PENS device will help reduce the amount of opioid (the most commonly used analgesic agent) consumed in the post operative period and hence their associated side effects. The study will also analyse for improvements in other recovery parameters such as mobility, bowel movements, sedation scores, ease/ patient comfort with PENS device and these are translated as secondary outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •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
Reduction in postoperative pain scores as measured by NRS pain scale between 0-10
时间窗: POD 0-4 Postoperative hours 0-hrs, 2-hrs, 4-hrs, 8-hrs,12-hrs, 18-hrs, 24-hrs, 36-hrs, 48-hrs, 72-hrs, 96-hrs
次要结局
- Postoperative:(Reduction in opioid consumption)