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临床试验/NCT06789367
NCT06789367已完成4 期

The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response in PENG Block for Pediatric Hip Surgery

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:
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
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

This study aims to assess the impact of the administration route of dexamethasone (intravenous vs. perineural) on postoperative pain, inflammatory response, and neuromonitoring parameters in pediatric patients undergoing hip surgery. The primary outcome is postoperative pain intensity measured using an age-appropriate pain scale at multiple time intervals. Secondary outcomes include inflammatory markers such as neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), opioid consumption, time to first rescue analgesia, and overall patient recovery. This randomized, double-blinded study seeks to improve pain management strategies and optimize anesthesia protocols in pediatric hip surgery.

详细描述

Pediatric hip surgery is a complex procedure that can result in significant postoperative pain and an inflammatory response. Effective pain management is critical in this population to promote early mobilization, reduce opioid consumption, and minimize adverse outcomes. The pericapsular nerve group (PENG) block is a regional anesthesia technique that offers targeted analgesia for hip procedures while preserving motor function, making it particularly suitable for pediatric patients.

Dexamethasone is commonly used as an adjuvant in regional anesthesia to prolong analgesia and mitigate inflammation. However, the optimal administration route of dexamethasone in the context of PENG block for pediatric hip surgery remains unclear. This study is designed to compare the efficacy of intravenous versus perineural dexamethasone in prolonging postoperative analgesia and reducing inflammatory responses.

This prospective, randomized, double-blinded clinical trial will enroll pediatric patients undergoing elective hip surgery. Participants will be randomized into two groups: one group will receive intravenous dexamethasone, while the other will receive perineural dexamethasone administered as part of the PENG block. All patients will receive standardized general anesthesia and PENG block using a local anesthetic at a fixed concentration.

The primary outcome will be time to first request rescue analgesia. Secondary outcomes include the inflammatory response measured by NLR and PLR, postoperative pain intensity, assessed using an age-appropriate pain scale at predefined time intervals, total opioid consumption, and blood glucose levels. The study will also monitor neuromonitoring parameters during surgery to ensure patient safety and evaluate the influence of dexamethasone on neurological outcomes.

Safety will be closely monitored throughout the study, with particular attention to potential complications such as local anesthetic systemic toxicity (LAST) or dexamethasone-related adverse events.

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
3 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children scheduled for hip surgery
  • body weight > 5kg

排除标准

  • 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

perinerual dexamethasone

Active Comparator

PENG block + perineural dexamethasone

干预措施: perineural Dexamethasone 4mg (Drug)

intravenous dexamethasone

Active Comparator

PENG block + intravenous dexamethasone

干预措施: intravenous Dexamethsone 4mg (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

  • Total opioid consumption(48 hours after surgery)
  • Nerve damage(48 hours after surgery)
  • NRS(48 hours after surgery)
  • NLR(48 hours after surgery)
  • PLR(48 hours after surgery)
  • glucose(48 hours after surgery)
  • NRS(4 hours after surgery)
  • NRS(8 hours after surgery)
  • NRS(12 hours after surgery)
  • NRS(24 hours after surgery)
  • Nerve damage(12 hours after surgery)
  • Nerve damage(24 hours after surgery)
  • NLR(12 hours after surgery)
  • NLR(24 hours after surgery)
  • PLR(12 hours after surgery)
  • PLR(24 hours after surgery)
  • glucose(12 hours after surgery)
  • glucose(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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