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临床试验/NCT04227561
NCT04227561Unknown不适用

Analgesia for Pediatric Circumcision : Comparison of the Effectiveness of Neurostimulation-guided Pudendal Nerve Block to Ultrasound-guided Penile Nerve Block

Centre Hospitalier Universitaire Saint Pierre2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年1月17日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Time to first administration of analgesics (other than nervous blockage after induction of anesthesia)

研究概览

简要总结

Medical or ritual circumcisions are frequent interventions in children. To provide the best comfort to the patients, the anesthetists use regional anesthesia. Complementary to general anesthesia, this method allows to lower the need of opioids during and after the surgery, as well as a faster recovery.

The foreskin is innervated by the dorsal nerve of the penis which is the branch of the pudendal nerve. This nerve arises from the sacral plexus and more precisely the branches S2-3-4. There are two methods to block pudendal nerve. First, the pudendal nerve block is an old anesthetic technique developed in 1908, first for obstetrical analgesia and urological analgesia. It consists in injecting in the ischiorectal fossa, right at the end of Alcock's canal, a solution of local anesthetic. Second, the penile nerve block, described in the middle of the seventies, consists in injecting a solution of local anesthetic that blocks only the terminal part of the pudendal nerve.

Those two nerve blocks have been subject to many publications, especially concerning the method to apply to optimize their efficiency. The literature review led to this conclusion: The penile nerve block should be ultrasound guided and the pudendal nerve block should be done with a neurostimulator.

The aim of this study is to compare the analgesic efficiency of the ultra-sound guided penile nerve block to the pudendal nerve block with neurostimulation, for the pediatric circumcision.

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, Outcomes Assessor)

入排标准

年龄范围
1 Year 至 2 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • One to two years old boys
  • Ritual or medical, elective circumcision.

排除标准

  • Refusal from parents
  • Allergy to local anesthetics
  • Documented coagulation disorders

结局指标

主要结局

Time to first administration of analgesics (other than nervous blockage after induction of anesthesia)

时间窗: up to 24 hours

Pain evaluation during surgery will be based on hemodynamic fluctuations (elevation of 15% or more of the heart rate or blood pressure) and variations of skin conductance (Med-Storm's pain monitor). In the postoperative period, the pain will be evaluated with the EVENDOL score and the variations of skin conductance

次要结局

  • Postoperative pain assessed with the EVENDOL score(up to 24 hours)
  • Postoperative pain assessed by a pain monitor device (skin conductance algesimeter)(up to 24 hours)

研究者

发起方
Centre Hospitalier Universitaire Saint Pierre
申办方类型
Other
责任方
Sponsor

研究点 (2)

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