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临床试验/NCT06789029
NCT06789029招募中4 期

The Effect of Dexamethasone Administration Route and Local Anesthetic Concentration on Pain, Inflammatory Response, and Neuromonitoring in Children Undergoing Scoliosis Correction

Poznan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Time to first rescue opioid analgesia

研究概览

简要总结

Scoliosis correction surgery in children is a complex procedure with significant risks, including postoperative pain, inflammatory response, and potential neurological complications. Effective pain control and minimizing inflammation are critical for faster recovery and improved patient outcomes. Dexamethasone is commonly used as an adjuvant in regional anesthesia due to its anti-inflammatory effects and ability to prolong analgesia. However, limited research exists on the optimal route of dexamethasone administration (intravenous vs. perineural) and the best local anesthetic concentration for pain management, inflammatory response, and neuromonitoring during surgery.

This study aims to compare the effects of different dexamethasone administration routes and local anesthetic concentrations on postoperative pain, inflammation (NLR, PLR), and neuromonitoring in pediatric scoliosis surgery. Results may improve regional anesthesia protocols, enhance patient safety, and offer valuable insights for clinical practice.

详细描述

Scoliosis correction surgery in children is a complex procedure associated with a significant risk of postoperative pain, inflammatory response, and potential neurological complications. Ensuring optimal pain control and minimizing adverse inflammatory responses is crucial for shortening the recovery period, improving patient comfort, and reducing the risk of long-term complications. In clinical practice, dexamethasone is frequently used as an adjuvant in regional anesthesia techniques due to its anti-inflammatory properties and its potential to prolong the analgesic effect.

Although the use of dexamethasone as an adjuvant in regional anesthesia is well known, there is limited research focusing on the impact of its route of administration (local versus intravenous) and the optimal concentration of local anesthetic agents on the effectiveness of pain control, inflammatory response, and neuromonitoring parameters during surgical procedures in children. Understanding these aspects is particularly important in complex procedures such as scoliosis correction surgery, where precise neurological function monitoring is essential for patient safety.

The objective of the proposed study is to evaluate the impact of different dexamethasone administration routes (intravenous and perineural) and varying concentrations of local anesthetic agents on postoperative pain, inflammatory response (measured using NLR and PLR indices), and neuromonitoring parameters in children undergoing scoliosis correction surgery. The findings from this study may contribute to the development of more effective and safer regional anesthesia and analgesia protocols for this patient group.

Conducting this study will provide new insights into the optimization of anesthesia in pediatric spinal surgery, potentially leading to improved treatment outcomes and patient safety, as well as valuable data for clinical practice regarding the selection of anesthetic strategies.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •>10 and <18 years old
  • •scheduled for idiopathic scoliosis surgery

排除标准

  • •included infection at the site of the regional block,
  • •coagulation disorders,
  • •immunodeficiency,
  • •American Society of Anesthesiologists (ASA) physical status of IV or higher,
  • •history of regular steroid medication.

研究组 & 干预措施

perineural Dexamethasone

Active Comparator

Erector Spinae Plane Block with 0.2% ropivacaine with perineural 0.1mg/kg dexamethasne

干预措施: perineural Dexamethasone (Drug)

intravenous dexamethasne

Active Comparator

Erector Spinae Plane Block with 0.2% ropivacaine with intravenous 0.1mg/kg dexamethasne

干预措施: intravenous Dexamethasone (Drug)

结局指标

主要结局

Time to first rescue opioid analgesia

时间窗: 48 hours after surgery

Time to first rescue opioid analgesia

次要结局

  • intraoperative requirement for propofol(durring surgery)
  • intraoperative requirement for remifentanil(durring surgery)
  • MEP(durring surgery)
  • Total opioid consumption(48 after surgery)
  • NRS(48 hours after surgery)
  • NLR(48 hours after surgery)
  • PLR(48 hours after surgery)
  • NRS(6 hours after surgery)
  • NRS(12 hours after surgery)
  • NRS(24 hours after surgery)
  • NRS(36 hours after surgery)
  • NLR(12 hours after surgery)
  • PLR(12 hours after surgery)
  • PLR(24 hours after surgery)

研究者

发起方
Poznan University of Medical Sciences
申办方类型
Other
责任方
Sponsor

研究点 (1)

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