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临床试验/NCT06752252
NCT06752252招募中不适用

Ultrasound Guided Paravertebral Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Inguinal Hernia Repair in Pediatric Patients: a Randomized Clinical Trial

Zagazig University2 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2024年12月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
158
试验地点
2
主要终点
The total amount of rescue analgesia (Ibuprofen consumption)

研究概览

简要总结

The aim of the study is to compare postoperative analgesia in pediatric patients undergoing inguinal hernia repair by comparing the efficacy of ultrasound guided paravertebral block versus ultrasound guided erector spinae plane block.

详细描述

  • To assess the total amount of rescue analgesic consumption in the first 24 hours post-operatively in each group.
  • To measure the time of first request of rescue analgesia and to assess pain intensity at rest (static) and after movement or coughing (dynamic) using 10 points Modified Objective Pain Score (MOPS).
  • To record the incidence of complications (hematoma, local anesthetic toxicity, pneumothorax, infection, hypotension, epidural or intrathecal spread).
  • Over all parent's satisfaction: The parents will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia).

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)

盲法说明

anesthetist not sharing in the study will assess patients

入排标准

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

入选标准

  • •1 - Parents acceptance
  • •Age: preschool and school age child (24 months-12 years old).
  • •Sex: both sex (males or females).
  • •Physical status: ASA 1& II.
  • •Type of operation: elective unilateral inguinal hernia repair

排除标准

  • •1- Patient with any contraindications of regional blocks (as coagulopathy or local infection at injection site)
  • •Patients with known history of allergy to the study drugs (bupivacaine and lidocaine).
  • •Advanced hepatic, renal, cardiovascular, neurologic and respiratory diseases.

研究组 & 干预措施

Group paravertebral (PVB) block

Active Comparator

In the lateral decubitus and after sterilization and identifying the level of T10 ,linear ultrasound probe will be placed in the midline over the spinous process at the chosen level, then the probe will be moved laterally to view the lamina and hyperechoic transverse process ,the pleural should be visible as a bright white line .The needle should be inserted in -plane from lateral to medial and the needle tip should end in a hypoechoic triangular space .Correct needle placement should be confirmed by anterior displacement of pleura with injection of small volume of saline then 0.5 ml/kg of a mixture of 0.25 ℅ bupivacaine and 1℅ lidocaine (1:1) will be injected

干预措施: ultrasound guided paravertebral block (Procedure)

Group erector spinae plane (ESP) block

Active Comparator

In the lateral decubitus position ,after sterilization, the linear ultrasound probe will be placed over transverse process of T10 ,after optimizing the image in sagittal or transverse scanning ,A 50 mm 22-G needle will be placed under the erector spinae muscle in -in plane orientation until it contacted T8 transverse process in the cranial caudal direction ,after hydro dissection and confirmation that the tip of the needle is between the transverse process and the fascia of the erector spinae muscle group, 0.5 ml/kg of a mixture of 0.25 ℅bupivacaine and 1℅ lidocaine (1:1) will be injected and the surgery will be started after 15 min

干预措施: Ultrasound guided erector spinae plane block (Procedure)

Control group (group C)

Active Comparator

will receive standard general anesthesia with pain management protocol without regional block. Pain management protocol for all patients will include IV paracetamol 15 mg/kg every 6 hrs. (max dose for children <50 kg is 60 mg/kg daily and if body weight ≥ 50 kg max dose is 4 gm daily) . Ibuprofen will be given as rescue analgesia 10 mg/kg IV if MOPS was > 3 at rest or after movement and can be repeated every 6 hrs not exceeding 400 mg/dose and max daily dose 40 mg/kg.

干预措施: control group C (Procedure)

结局指标

主要结局

The total amount of rescue analgesia (Ibuprofen consumption)

时间窗: for 24 hours postoperative

The total consumption of rescue analgesia (Ibuprofen consumption) postoperative

次要结局

  • Pain intensity at rest (static) and after movement or coughing (dynamic)(0 minutes immediate postoperative ( on arrival to PACU), 30 minutes, 1hs, 2hs, 4hs, 8hs, 12 hrs and 24hs postoperatively)
  • The time to first request of rescue analgesia (Ibuprofen)(for 24 hours postoperative)
  • The total number of patients requiring additional dose of intraoperative fentanyl.(during operation period)
  • To record the incidence of complications(24 hours postoperative)
  • Over all parent's satisfaction(24 hours postoperative)

研究者

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

Dina Abdelhameed Elsadek Salem

principle investigator

Zagazig University

研究点 (2)

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