Transcutaneous Electric Nerve Stimulation (TENS) for Pain Relief During Extracorporeal Shock-wave Lithotripsy (ESWL)
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain intensity measure using visual analogue scale
研究概览
简要总结
This study evaluates pain relief during extracorporeal shock-wave Lithotripsy by using transcutaneous electrical nerve stimulation (TENS) and comparing it with fentanyl which is a narcotic analgesic. Half of the participants will receive a primary fentanyl dose together with TENS application, another half will receive a primary fentanyl dose. All patients will receive fentanyl increments if they still complained of pain.
详细描述
The ideal anesthesia technique for ESWL must provide good analgesia, sufficient sedation, and rapid recovery with minimal side effects. Opioids are commonly used analgesics during ESWL. Fentanyl is a potent synthetic narcotic, which has rapid onset and a short duration of action, it offers an acceptable analgesia during ESWL but has a noticeable respiratory depression.
Transcutaneous electrical nerve stimulation (TENS) is a method in which low voltage electrical impulses transmit through electrodes attached to the skin over a painful area. It is usually used to relieve a variety of painful conditions. A TENS unit contains electrical signal generator, a battery in addition to a set of electrodes. The TENS is small, programmable and the generator can deliver stimuli with different current intensities, pulse rates and pulse width.
The mechanism of analgesia by TENS has been explained by many theories. the gate control theory by Melzack and Wall, stated that "when an electrical current is applied to a painful area, transmission of pain through small diameter fibers is inhibited by the activity of the large diameter, fast-conducting proprioceptive sensory fibers, closing the gate to the pain perception to the brain". Another mechanism suggested is activation of descending inhibitory pathway, via release of endogenous opioids.
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, Investigator)
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
- •Patients scheduled for extracorporeal shock-wave Lithotripsy (ESWL), having a solitary renal stone 6 - 15 mm.
- •Age18 to 75 years old.
- •ASA physical status I -II.
- •BMI of 25- 30.
排除标准
- •Patients with bleeding and coagulation disorder.
- •Hypertension.
- •Pregnancy,
- •Patient with demand pacemaker.
- •Dermatological lesions at the site of ESWL e.g. eczema or dermatitis.
- •Drug or alcohol addiction.
研究组 & 干预措施
Transcutaneous electrical nerve stimulation (TENS)
Patients will receive IV fentanyl 1µg /Kg with the application of conventional TENS in which constant mode will be chosen. Assessment of pain will be done using visual analogue scale (VAS), every 10 minutes. If VAS ≥ 3 this indicates giving IV increments of 20µg of fentanyl.
干预措施: Transcutaneous electrical nerve stimulation (Device)
Transcutaneous electrical nerve stimulation (TENS)
Patients will receive IV fentanyl 1µg /Kg with the application of conventional TENS in which constant mode will be chosen. Assessment of pain will be done using visual analogue scale (VAS), every 10 minutes. If VAS ≥ 3 this indicates giving IV increments of 20µg of fentanyl.
干预措施: Fentanyl (Drug)
Fentanyl
Patients will receive IV fentanyl 1µg /Kg. Assessment of pain will be done using visual analogue scale (VAS), every 10 minutes. If VAS ≥ 3 this indicates giving IV increments of 20µg of fentanyl.
干预措施: Fentanyl (Drug)
结局指标
主要结局
Pain intensity measure using visual analogue scale
时间窗: 10 minutes
patients will be instructed to mark the line with a pencil (0 = no pain 10= worst pain).
次要结局
- Fentanyl consumption(during the procedure of ESWL)
研究者
Randa Ali Shoukry
Assistant Professor
Ain Shams University