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临床试验/NCT06086106
NCT06086106已完成不适用

Comparison Between the Caudal Block and Other Methods of Postoperative Pain Relief in Children Undergoing Circumcision: A Prospective Randomized Study"

Salmaniya Medical Complex1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Pain postoperative assessment tools in post anesthesia care unit.

研究概览

简要总结

Prospective, randomized, case-controlled trial study. Observation post-operatively:

Aims: This study aimed to compare the effectiveness of the caudal block CB with other methods of postoperative pain release.

详细描述

a study Sample size: all patients, for a total of 90 boys going for circumcision surgery. I was recruited over the course of four months, starting on 1 May 2023. The patients will be divided into three groups: A caudal block(CB), B systemic opioids, and C dorsal penile block (DPNB) Techniques used in pediatric surgeries to provide analgesia for penile surgery such as circumcision. All patients had operations and were observed, and the three groups were compared based on hemodynamic stability, pain scores, duration of sedation, analgesia need, and parental satisfaction. where the Face, Leg, Activity, and Cry Consolability (FLACC) pain scale and behaviors were used to observe and compare the three groups. Pain scores were recorded by separate anesthesiologists or nurses in the post-anesthesia care unit. All statistical work will be carried out using Spss version 27 (Spss Inc., Chicago, USA) and Prism GraphPad version 9.4.1 (GraphPad, San Diego, USA) The categorical and numerical variables and demographic data of three groups were collected and reviewed by two authors. the study has shown that the caudal block produces higher levels of analgesia and a longer period of pain release than the penile block, even if both methods help relieve pain during pediatric surgical procedures.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
3 Months 至 3 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • American Society of Anesthesiologists Physical Status classification one
  • aged from three months up to three years

排除标准

  • allergic to local anesthetics,
  • bleeding diatheses,
  • coagulopathy,
  • infection at the injection site,

研究组 & 干预措施

group B systemic opioids for pain relive

systemic opioids belong to a class of analgesics, they act by attaching to opioid receptors in the brain and spinal cord. For relief of pain, they are frequently utilized in a variety of surgical procedures and can be given intravenously, and in intramuscular injections. Although opioids are considered highly effective in pain control, they can lead to several adverse effects, such as nausea, vertigo, and respiratory depression, some of which can be dangerous.

干预措施: caudal block (Procedure)

group B systemic opioids for pain relive

systemic opioids belong to a class of analgesics, they act by attaching to opioid receptors in the brain and spinal cord. For relief of pain, they are frequently utilized in a variety of surgical procedures and can be given intravenously, and in intramuscular injections. Although opioids are considered highly effective in pain control, they can lead to several adverse effects, such as nausea, vertigo, and respiratory depression, some of which can be dangerous.

干预措施: Dorsal Penile Nerve Block DPNB (Procedure)

group B systemic opioids for pain relive

systemic opioids belong to a class of analgesics, they act by attaching to opioid receptors in the brain and spinal cord. For relief of pain, they are frequently utilized in a variety of surgical procedures and can be given intravenously, and in intramuscular injections. Although opioids are considered highly effective in pain control, they can lead to several adverse effects, such as nausea, vertigo, and respiratory depression, some of which can be dangerous.

干预措施: Systemic opioids (Drug)

结局指标

主要结局

Pain postoperative assessment tools in post anesthesia care unit.

时间窗: 20 minutes after the intervention/procedure/surgery"

To gather information, a questionnaire consisting of two sections, the first section, demographic characteristics including age, and weight, and the second section consisting analgesia scale was used.This tool assesses pain in pediatric patients, preverbal children, and those who cannot express their pain verbally or accurately and is dependent on the assessment by the researcher based on the criteria of this scale. In this project, zero is analgesia, 1-3 is for mild pain, 4-6 is for moderate pain, and 7-10 is for severe pain the Face Legs a useful tool for parents to detect pain in their infants and young children. and toddlers

postoperative pain assessment

时间窗: "immediately after the intervention/procedure/surgery"

The circumcision of children is the most commonly performed surgical procedure in the world Likely, the greatest target for us as anesthesiologists is to control the pain postoperatively. Various techniques are used to manage pain. Two of these techniques are CB and DPNB, both considered as regional blocks and involve the administration of local anesthesia. Additionally, systemic opioids have shown potential for alleviating postoperative pain. This study aimed to explore the benefits and limitations of these techniques and provide insights into their effectiveness and impact on circumcised patients. By evaluating the use of CB, penile block, and opioids, we can recognize their usefulness in promoting safe and painless circumcision surgery.Considering the risk points, DPNB can cause hematoma, opioids can lead to respiratory depression plus nausea and vomiting, while CB can cause delayed micturition, failed block, and cerebrospinal fluid aspiration due to puncture of dura

次要结局

  • Differences between children pain scale after 6h(Differences between children who underwent circumcision' surgery with or without caudal block anesthesia in the average pain scores at the various time points, postoperative analgesia between children pain scores after 6hours)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Zeana gawe

Specialist Of Anesthesia

Salmaniya Medical Complex

研究点 (1)

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