Prospective, Randomized, Single Blind Trial of Preemptive Analgesic Effects of Popliteal Sciatic Nerve Block in Patients With Bilateral Hallux Valgus Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Analgesic duration of nerve block
研究概览
简要总结
The purpose of this study was to investigate the preemptive effect of ultrasound guided popliteal scistic nerve block on postoperative acute pain in patients with bilateral hallux valgus.
After induction of general anesthesia, the leg to be operated first is decided randomly. After the operation of one leg is completed, PSNB is performed on both legs with 0.2% Ropivacaine and surgery is started on the remaining legs.
When the surgery is over, check to see which foot pain begins first, how strong the pain is, and whether there are any side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults between the ages of 20 and 80
- •bilateral hallux valgus surgery on the same day
- •ASA class 1 or 2
- •Patients who have voluntarily agreed in writing to participate in the trial
排除标准
- •Patient with side effects on local anesthetics or steroids
- •Patient who are taboo of peripheral nerve block such as blood clotting disorder, infection, etc.
- •Patients with uncontrolled medical or psychiatric problem
- •Patient does not agree to participate in the study
- •Patients who are pregnant or lactating
研究组 & 干预措施
preoperative blocked leg: group preB
ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml Before surgical incision
干预措施: Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine (Drug)
postoperative blocked leg: group postB
ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml After surgical incision
干预措施: Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine (Drug)
结局指标
主要结局
Analgesic duration of nerve block
时间窗: at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1
The difference of NRS during study time between group preB and group postB The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. 0: No pain, 1-3: mild pain, 4-6: Moderate pain, 7-10: severe pain, 10: worst pain imaginable.
次要结局
- Difference of analgesic consumption between both group(at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1)
- side effect of popliteal sciatic nerve block(at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1)
研究者
Jong Hyuk Lee
clinical assistant professor
Asan Medical Center