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临床试验/NCT06530147
NCT06530147已完成不适用

Comparison Of The Effectiveness Of Transversalis Fascia Plane Block And Transversus Abdominis Plane Block For Postoperative Analgesia After Pediatric Lower Abdominal Surgeries

Kocaeli University1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2022年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
1
主要终点
Pain scores

研究概览

简要总结

In this study, the investigators compared ultrasound-guided transversalis fascia plane (TFP) block and transversus abdominis plane (TAP) block on postoperative analgesic effect in pediatric abdominal surgeries

详细描述

After being informed about the study and potential risks, written consent was obtained from all patients. In order to effectively manage postoperative analgesia in patients planned for lower abdominal surgery (inguinal hernia and undescended testicles), patients will begin to be observed after routine anesthesia and block techniques applied to the patients. After these procedures, the block is applied to the patient using the appropriate method, under aseptic conditions and under ultrasound guidance. Intraoperative hemodynamic changes of the patients, intraoperative opioid consumption and bispectral index monitoring values of the patients will be kept throughout the peroperative period. Postoperative follow-ups will be made at 0nd, 1st, 2nd, 4th, 6th, 12th, and 24th hours to evaluate the initial analgesic consumption, need for analgesics types, pain levels, and parental satisfaction. In this way, it is aimed to compare the Transversalis Fascia Plan Block and Transversus Abdominis Plan Block as an effective analgesic application in lower abdominal surgery in children and to show the analgesic method that can be used effectively in postoperative pain management.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologist Classification (ASA) I-II patients
  • 1-7 aged patients
  • patients who scheuled elective lower abdominal surgery (inguinal hernia and undescended testis)

排除标准

  • Use of anticoagulants
  • Allergy of medications to be used
  • Presence of infection the area where the block will be applied
  • American Society of Anesthesiologist Classification (ASA) III-IV patients
  • The study will not include any vulnerable population, such as those in restraints, those in intensive care and those who are unconscious, and those who cannot give personal consent or impressionable subjects.
  • Patients who do not agree to participate in the research, parents/legal guardians
  • Patients who were operated on with a different incision than planned for any reason.

结局指标

主要结局

Pain scores

时间窗: at the 6th postoperative hou

Our primary aim to compare the effect of both blocks groups on the FLACC (Face, Legs, Activity, Cry, Consolability) pain scores at the 6th postoperative hour. FLACC pain scale, zero is designated as the lowest pain level, and ten as the highest pain level.

次要结局

  • Need for analgesic(During postoperative 24 hours)
  • Nause and vomiting(During postoperative 24 hours)
  • Parents satisfaction(During postoperative 24 hours)
  • Pain scores(During postoperative 24 hours)
  • Time elapsed until the first analgesic requirement(During postoperative 24 hours)

研究者

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

Hasibe Irban

Principal Investigator

Kocaeli University

研究点 (1)

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