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临床试验/NCT04031196
NCT04031196已完成不适用

Ultrasound-guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Laparoscopic Appendicectomy: A Randomized Clinical Study

Zagazig University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年10月1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
34
试验地点
2
主要终点
changes in intraoperative mean arterial blood pressure (MAP) values

研究概览

简要总结

QL block has been recently described for chronic pain following abdominal hernia repair, and for postoperative analgesia following abdominal surgery as it leads to complete pain relief in the dermatomal area from (T6 - L1). Theoretically, QL blocks might give better and longer-lasting analgesia compared to the US-guided anterior TAP block due to a spread to the thoracic paravertebral space and sympathetic nerves in the thoracolumbar fascia, so visceral afferent pathways to the medulla can be blocked.

详细描述

Recently, the laparoscopic technique has been successfully used for many pediatric surgical cases. The laparoscopic appendicectomy is favored over the traditional open method, as it has a lower incidence of postoperative surgical complications and faster recovery to normal daily activities. Although it is considered as minimally invasive surgery, patients may require hospitalization for over 24 hours following laparoscopic appendicectomy, and postoperative pain which is caused by the surgical wound and visceroperitonitic pain as a result of peritoneal inflammation and infection, may extend the length of hospital stay.

Regional anesthesia techniques are commonly enhanced for pain management in pediatric surgical procedure as they decrease parenteral opioid requirements and improve patient-parent satisfaction [6].

The Transversus Abdominis Plane (TAP) block was first described in 2004 by McDonnell et al. using anatomical landmark guidance, and ultrasound-guided technique was later popularized by Hebbard et al. TAP block is aiming to block sensory nerves that course between the transversus abdominis and internal oblique muscles and supply the anterior abdominal wall, where local anesthetic is injected into the transversus abdominis fascial plane. Many clinical studies have reported the efficacy of TAP block in providing adequate postoperative analgesia for lower abdominal surgery.

Quadratus Lumborum block was initially described by R.Blanco as an abstract at the annual European Society of Regional Anaesthesia (ESRA) congress in 2007, where the local anesthetic (LA) was injected in the anterolateral aspect of the QL muscle (type 1 QL block). Later, J. Børglum used posterior transmuscular approach by detecting Shamrock sign and injecting the LA in the anterior aspect of the QL (type 3 QL block). Recently, R. Blanco described another approach by injecting the LA in the posterior aspect of the QL muscle (type 2 QL block), which may be easier and safer as the LA is injected in a more superficial plane, so the risk of intra-abdominal complications and lumbar plexus injuries is reduced. And finally the intramuscular QL block (type 4 QL block), the local anesthetic is injected directly into the QL muscle.

We hypothesize that ultrasound-guided QL block will be more superior than or equal to TAP block in providing postoperative analgesia for children undergoing laparoscopic appendicectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

盲法说明

the participants were masked for the type of regional anesthesia given the care provider was blind to the type of the regional block given to the patient and he was asked to assess the visual analogue scale score, first time of rescue analgesia, the total dose of rescue analgesia given and postoperative side effects.

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • parent and patient acceptance,
  • Children 7-12 years old,
  • 20-35kg bodyweight,
  • ASA I-II,
  • and scheduled for Laparoscopic appendicectomy

排除标准

  • Patients refusing regional anesthesia,
  • those with bleeding disorders,
  • skin lesion at the needle insertion site,
  • liver disease,
  • peritonitis,
  • and emergency cases

结局指标

主要结局

changes in intraoperative mean arterial blood pressure (MAP) values

时间窗: at base line (To), 3 minutes(min) after induction of general anesthesia, 10 min after intubation (immediately before performing the block (T1)), 15 min after performing the block (T2),and intraoperative values every 15 min till the end of surgery(T3)

(mm Hg)

changes in intraoperative heart rate (HR) values

时间窗: at base line (To), 3 minutes(min) after induction of general anesthesia, 10 min after intubation (immediately before performing the block (T1)), 15 min after performing the block (T2),and intraoperative values every 15 min till the end of surgery(T3)

(beats/minute)

changes in the degree of pain perception by patient

时间窗: Patients were assessed in the immediate post operative period and then at 2 hour(h), 4h, 6h , 8h , 12 h, 18 h and at 24 hours postoperative for the quality of analgesia

measured by visual analogue scale(VAS), The patient was trained to report the level of pain on VAS scale from 0 to 10 (where 0 indicates no pain and 10 indicates the most severe pain).

次要结局

  • post operative nausea and vomiting(in the first postoperative 24 hours)
  • total intraoperative fentanyl consumption(during the time of the surgical procedure)
  • 1st time of rescue analgesics(during the first postoperative 24 hours)
  • total amount of rescue analgesic consumed(in the first postoperative 24 hours)
  • degree of patient and parent satisfaction(at the end of the first postoperative 24 hours)

研究者

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

Shereen Elsayed Abd Ellatif

lecturer of anesthesia and surgical intensive care

Zagazig University

研究点 (2)

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