The Analgesia Effect of Electroacupuncture of Battlefield Acupuncture (BFA) Versus Sham Electroacupuncture on Pain, Analgesic Dose Reduction and Quality of Life Post Percutaneous Nephrolithotomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
The goal of this clinical trial is to learn the effect of ear electroacupuncture BFA therapy in reducing pain, analgesic dose, and improving patient quality of live post percutaneous nephrolithotomy surgery. The main questions it aims to answer are:
- Does BFA ear electroacupuncture reduce postoperative pain of percutaneous nephrolithotomy surgery better than sham electroacupuncture group?
- Does BFA ear electroacupuncture reduce postoperative analgesic dose of percutaneous nephrolithotomy surgery better than sham electroacupuncture group?
- Does BFA ear electroacupuncture improve postoperative quality of life of percutaneous nephrolithotomy surgery better than sham electroacupuncture group?
Researchers will compare ear electroacupuncture BFA to sham electroacupuncture to see the different analgesia effect between these groups.
Participants will:
- Get ear electroacupuncture BFA or sham electroacupuncture therapy, 2 hours before surgery for 30 minutes
- Take drug paracetamol 1000 mg intravenous after surgery according to the needs of the patient's pain complaints after surgery in both groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participants, the outcome assessors will be blinded to group allocation
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
- 否
入选标准
- •Men or women aged 18-65 years
- •Patients who have been diagnosed with kidney stones measuring > 2 cm and will undergo PCNL surgery
- •VAS score <7, assessed 2 hours before PCNL surgery
- •Receive standard analgesic therapy
- •Willing to participate in this study until completion and sign an informed consent.
排除标准
- •Kidney anatomical abnormalities
- •Ear deformities (microtia)
- •Patients with cognitive impairment, uncooperative (receiving antidepressants or strong opioid or narcotic analgesics)
- •Tumors, wounds or skin infections in the needling area.
- •Heart rhythm disorder, unstable hemodynamics that require intensive care including extremely high body temperature and using a pacemaker.
- •Allergy to acupuncture needles or certain metals
- •Patients who have had a DJ stent or nephrostomy before PCNL
- •History of metal implants in the body except amalgam
研究组 & 干预措施
Intervention Group
The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy
干预措施: The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy (Device)
Control Group
The sham electroacupuncture and paracetamol intravenous therapy
干预措施: The sham electroacupuncture and paracetamol intravenous therapy (Device)
结局指标
主要结局
Visual Analogue Scale
时间窗: Before therapy, minute 0, hour 8, hour 24, hour 48
Visual Analogue Scale is the tool that measures pain intensity. It use a scale with a minimum range of 0 and a maximum of 10, where 0 indicates no pain and 10 indicates the worst pain. Higher scores indicate worse pain.
次要结局
- Analgesic dose reduction(hour 8, hour 24, hour 48)
- Short Form 36 (SF-36) Questionnaire(Before therapy, day 7)
- Adverse effects(Day 7)
研究者
Hermin Widyaprastuti
Medical Doctor
Indonesia University