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临床试验/NCT07061678
NCT07061678已完成4 期

The Effect of Dexamethasone Administration Route in Infraclavicular Brachial Plexus Block for Pediatric Arm and/or Hand Surgery

Poznan University of Medical Sciences4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年10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
已完成
发起方
入组人数
90
试验地点
4
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 and inflammatory response in pediatric patients undergoing hip surgery. The primary outcome is postoperative pain intensity measured using an age-appropriate scale at multiple 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 arm surgery.

详细描述

Pediatric arm 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.

Dexamethasone is an adjuvant in regional anesthesia that prolongs analgesia and mitigates inflammation. However, the optimal administration route of dexamethasone in infraclavicular brachial plexus block for pediatric arm 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 infraclavicular brachial plexus block. All patients will receive standardized spinal anesthesia under mild sedation and infraclavicular brachial plexus 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.

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 arm/wrist/hand 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

intravenous dexamethasone

Active Comparator

infraclavicular brachial plexus block + intravenous dexamethasone

干预措施: intravenous dexamethasone (Drug)

perinerual dexamethasone

Active Comparator

infraclavicular brachial plexus block + perineural dexamethasone

干预措施: perineural dexamethasone (Drug)

0.2ml/kg 0.2% ropivacaine

Placebo Comparator

infraclavicular brachial plexus block

干预措施: 0.2ml/kg 0.2% ropivacaine (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)
  • NRS(48 hours after surgery)
  • Nerve damage(48 hours after surgery)
  • NLR(48 hours after surgery)
  • PLR(48 hours after surgery)
  • glucose(48 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 (4)

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