Comparison of Perineural Versus Intravenous Dexamethasone as an Adjuvant to Brachial Plexus Block in Pediatric Hand and Forearm Surgery: A Randomized Double-Blind Placebo-Controlled Trial With Neurological Safety Evaluation and Neurofilament Light Chain Biomarker Assessment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence of Persistent Neurological Deficit
研究概览
简要总结
This clinical trial will evaluate the neurological safety and analgesic effectiveness of dexamethasone administered perineurally or intravenously as an adjuvant to brachial plexus block in children undergoing hand or forearm surgery. Dexamethasone is commonly used to prolong the duration of regional anesthesia, but there is limited evidence on long-term neurological safety, particularly in pediatric patients.
All participants will receive a single-shot brachial plexus block using ropivacaine under ultrasound guidance. Patients will be randomized into one of three treatment groups:
perineural dexamethasone, intravenous dexamethasone, or placebo. The primary objective is to determine whether perineural dexamethasone causes any clinically significant nerve injury compared with intravenous administration or placebo. Neurological function will be assessed clinically and via serum neurofilament light chain (NfL) levels over a 12-month follow-up period.
This study may provide evidence regarding the long-term safety profile of perineural dexamethasone in children and help establish evidence-based dosing and administration guidelines.
详细描述
Regional anesthesia using brachial plexus block is routinely used for pediatric upper limb surgery, but the long-term neurological safety of perineural dexamethasone remains uncertain. Previous adult studies and early pilot investigations suggest that dexamethasone increases the duration of analgesia and may reduce opioid requirements, but pediatric data remain scarce.
This randomized double-blind placebo-controlled clinical trial will compare three approaches:
perineural dexamethasone, intravenous dexamethasone, placebo. Neurological integrity will be evaluated using structured neurological examinations and serial measurement of serum neurofilament light chain (NfL), a biomarker of peripheral nerve damage. Functional recovery, pain scores, opioid use, and adverse events will also be assessed. Each patient will be followed for 12 months.
The results may guide pediatric regional anesthesia practice and help determine whether perineural dexamethasone is safe with regard to neurologic sequelae.
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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 3 months to 16 years
- •Scheduled elective hand or forearm surgery under general anesthesia with a brachial plexus block
- •ASA physical status I-III
- •Planned use of ultrasound-guided regional anesthesia
- •Written informed consent from parent(s) or legal guardian and age-appropriate assent from the child
排除标准
- •Pre-existing neurological disease or peripheral neuropathy
- •Preoperative sensory deficit in the operative limb
- •Infection at or near the needle insertion site
- •Coagulopathy or therapeutic anticoagulation
- •Systemic infection or sepsis
- •Chronic steroid therapy within 30 days before surgery
- •Known allergy to ropivacaine or dexamethasone
- •Diabetes mellitus
- •BMI > 99th percentile for age and sex.
- •Pregnancy or breastfeeding
- •Participation in another interventional clinical trial within 30 days
- •Refusal of consent
研究组 & 干预措施
Perineural Dexamethasone + Intravenous Placebo
Brachial plexus block with ropivacaine + dexamethasone perineurally 0.1 mg/kg (max 4 mg) and IV 0.9% NaCl.
干预措施: pn dexamethasone (Drug)
Placebo (IV + Perineural)
Brachial plexus block with ropivacaine + 0.9% NaCl both IV and perineurally.
干预措施: 0.9%NaCl (Drug)
Intravenous Dexamethasone + Perineural Placebo
Brachial plexus block with ropivacaine + dexamethasone IV 0.1 mg/kg (max 8 mg) and perineural 0.9% NaCl.
干预措施: iv dexamethasone (Drug)
结局指标
主要结局
Incidence of Persistent Neurological Deficit
时间窗: up to 12 months
Incidence of sensory or motor neurological deficit attributed to the block that persists ≥3 months postoperatively.
次要结局
- Time to First rescue analgesia(Within 0-48 hours after surgery.)
- Total Opioid Consumption(0-48 hours after surgery.)
- Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale(Post-anesthesia care unit (PACU), 2 hours after surgery.)
- Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale(Post-anesthesia care unit (PACU), 6 hours after surgery.)
- Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale(Post-anesthesia care unit (PACU), 12 hours after surgery.)
- Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale(Post-anesthesia care unit (PACU), 24 hours after surgery.)
- Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale(Post-anesthesia care unit (PACU), 48 hours after surgery.)
- Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)(Post-anesthesia care unit (PACU), 2 hours after surgery.)
- Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)(Post-anesthesia care unit (PACU), 6 hours after surgery.)
- Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)(Post-anesthesia care unit (PACU), 12 hours after surgery.)
- Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)(Post-anesthesia care unit (PACU), 24 hours after surgery.)
- Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)(Post-anesthesia care unit (PACU), 48 hours after surgery.)
- Adverse Events(Up to 30 days after surgery.)
- Incidence of perioperative hyperglycemia(Up to 24 hours after surgery.)