Pudendal Block Versus Penian Block For Circumcision In Children: A Double Blind Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- postoperative pain score
研究概览
简要总结
The authors study the efficacy of the pudendal versus penile block for the relief of postoperative pain in children receiving ambulatory circumcision.
In this prospective, double-blind, randomized, parallel-arm trial, 60 children recruited during the anesthesia consultation will be allocated a general anesthesia with a pudendal block (PUD group) or a penile block (PEN group).
Each block will be made with equal parts lidocaine 1% and ropivacaine 0.75% (0.3 ml/kg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •circumcision in day surgery hospital
排除标准
- •allergy to amino-amide local anesthetics
- •parental consent not received
- •infection at injection site
研究组 & 干预措施
Pudendal Block
The anesthesia is produced by blocking the pudendal nerves near the ischial spine of the pelvis.Local anesthetic (mixed of ropivacaine and lidocaine) is injected into the pudendal canal where the pudendal nerve is located.
干预措施: circumcision (Procedure)
Pudendal Block
The anesthesia is produced by blocking the pudendal nerves near the ischial spine of the pelvis.Local anesthetic (mixed of ropivacaine and lidocaine) is injected into the pudendal canal where the pudendal nerve is located.
干预措施: Lidocaine (Drug)
Pudendal Block
The anesthesia is produced by blocking the pudendal nerves near the ischial spine of the pelvis.Local anesthetic (mixed of ropivacaine and lidocaine) is injected into the pudendal canal where the pudendal nerve is located.
干预措施: Ropivacaine (Drug)
Penian Block
The anesthesia is produced by blocking the dorsal penile nerves. Local anesthetic (mixed of ropivacaine and lidocaine)is injected under the pubis symphysis just below the Buck fascia where the nerve is located.
干预措施: circumcision (Procedure)
Penian Block
The anesthesia is produced by blocking the dorsal penile nerves. Local anesthetic (mixed of ropivacaine and lidocaine)is injected under the pubis symphysis just below the Buck fascia where the nerve is located.
干预措施: Lidocaine (Drug)
Penian Block
The anesthesia is produced by blocking the dorsal penile nerves. Local anesthetic (mixed of ropivacaine and lidocaine)is injected under the pubis symphysis just below the Buck fascia where the nerve is located.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
postoperative pain score
时间窗: pain score at 0 hours postoperatively
using the FLACC (Face Leg Activity Cry Consolability) Scale
次要结局
- Degree of satisfaction of the patient or his/her parents and the surgeon assessed by telephone interview(Day 5 after the procedure)
研究者
JOHN NICOLARDOT
MD
Université Libre de Bruxelles