A Randomized, Double-Blinded, Controlled Trial Comparing Perineural Dexamethasone, Dexmedetomidine, and Their Combination as Adjuvants to Ropivacaine for Popliteal Sciatic Nerve Block in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Time to First Rescue Analgesia
研究概览
简要总结
This clinical study will evaluate three commonly used medications that can be added to local anesthetic during a popliteal sciatic nerve block in children undergoing surgery of the lower leg or foot. These medications-dexamethasone, dexmedetomidine, or a combination of both-may help the nerve block last longer and provide better postoperative pain control.
All participating children will receive a standard popliteal sciatic nerve block with ropivacaine, a commonly used local anesthetic. They will then be randomly assigned to one of three groups: (1) ropivacaine with dexamethasone, (2) ropivacaine with dexmedetomidine, or (3) ropivacaine with both dexamethasone and dexmedetomidine. Neither the children, parents, nor the clinical staff assessing pain will know which medication was given.
The goal of this study is to determine whether the combination of dexamethasone and dexmedetomidine provides longer pain relief and reduces the need for additional pain medication compared with either medication alone. The results may help identify the most effective and safest strategy for improving postoperative comfort in pediatric patients receiving regional anesthesia.
详细描述
Popliteal sciatic nerve block is frequently used in pediatric anesthesia to provide effective pain control for surgical procedures involving the lower leg, ankle, and foot. Although ropivacaine alone offers good analgesia, its duration is limited, and additional medications (adjuvants) are often added to prolong the effect of the block. Two commonly used adjuvants are dexamethasone, a corticosteroid, and dexmedetomidine, an alpha-2 adrenergic agonist. Each of these medications has been shown to extend the duration of analgesia, but it remains unclear whether combining them provides an additive or potentially synergistic benefit.
This randomized, double-blinded, controlled clinical trial will compare three perineural adjuvant strategies: dexamethasone, dexmedetomidine, and their combination. All participants will receive a single-shot popliteal sciatic nerve block with 0.2% ropivacaine. Children will then be randomized into one of three treatment arms:
- ropivacaine with perineural dexamethasone,
- ropivacaine with perineural dexmedetomidine, or
- ropivacaine with a perineural combination of dexamethasone and dexmedetomidine. Pain scores, block duration, opioid use, and recovery parameters will be assessed by trained observers who are blinded to group assignment. The primary aim is to determine whether the combination of dexamethasone and dexmedetomidine leads to superior analgesia compared with either drug alone. Secondary aims include evaluating the time to first rescue analgesia, total postoperative opioid requirements, behavioral pain scores (e.g., FLACC), adverse events, and early functional recovery.
This study seeks to provide high-quality evidence to guide the optimal choice of perineural adjuvants in pediatric regional anesthesia and may help establish best-practice recommendations for improving postoperative comfort and safety in children undergoing lower-limb surgery.
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 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3 to 12 years.
- •Scheduled for elective unilateral lower limb surgery (foot, ankle, or distal lower leg) under general anesthesia with a popliteal sciatic nerve block planned for postoperative analgesia.
- •ASA physical status I-III.
- •Ability of parents or legal guardians to understand the study procedures and provide written informed consent.
- •Child and parents/guardians available for telephone follow-up at 1 week and 1 month after surgery.
排除标准
- •Refusal of the parents/legal guardians to provide informed consent or refusal of the child to cooperate with anesthesia or study procedures.
- •Known allergy or hypersensitivity to ropivacaine, dexamethasone, dexmedetomidine, or any component of the study medications.
- •Pre-existing neurological deficit or neuromuscular disease affecting the lower limbs (motor or sensory).
- •Coagulopathy or current therapeutic anticoagulation that contraindicates regional anesthesia.
- •Local infection, inflammation, or skin lesions at the planned block site.
- •Severe cardiac, hepatic, renal, or respiratory disease that, in the investigator's opinion, increases the risk of study participation.
- •History of clinically significant arrhythmias, severe bradycardia, or second/third degree atrioventricular block not treated with a pacemaker.
- •Developmental delay or severe cognitive impairment that precludes reliable pain assessment or follow-up.
- •Chronic use of opioid analgesics or sedatives (≥ 2 weeks of daily use before surgery).
- •Participation in another interventional clinical trial within the last 30 days.
- •Any other condition considered by the investigator to interfere with protocol adherence, safety monitoring, or reliable outcome assessment.
研究组 & 干预措施
Perineural Dexamethasone
Children in this arm will receive a single-shot popliteal sciatic nerve block performed under ultrasound guidance with 0.3 mL/kg of 0.2% ropivacaine combined with 0.1 mg/kg perineural dexamethasone (maximum dose per institutional pediatric guidelines). The block will be performed using a 22-gauge echogenic needle under sterile conditions prior to the start of surgery. No additional adjuvants will be administered. Standard perioperative analgesia will be provided to all participants.
干预措施: Dexamethasone (Drug)
Perineural Dexmedetomidine
Children in this arm will receive a single-shot popliteal sciatic nerve block performed under ultrasound guidance with 0.3 mL/kg of 0.2% ropivacaine combined with 0.5 µg/kg perineural dexmedetomidine (maximum dose per institutional pediatric guidelines). A 22-gauge echogenic needle will be used for block placement under sterile conditions. No additional adjuvants will be administered. Standard perioperative analgesia will be provided to all participants.
干预措施: Dexmedetomidine (Drug)
Perineural Dexamethasone + Dexmedetomidine Combination
Children in this arm will receive a single-shot popliteal sciatic nerve block performed under ultrasound guidance with 0.3 mL/kg of 0.2% ropivacaine combined with 0.1 mg/kg perineural dexamethasone and 0.5 µg/kg perineural dexmedetomidine (maximum doses per institutional pediatric guidelines). The block will be performed with a 22-gauge echogenic needle under sterile conditions before surgery. Standard perioperative analgesia will be provided to all participants.
干预措施: Dexamethasone + Dexmedetomidine (Drug)
结局指标
主要结局
Time to First Rescue Analgesia
时间窗: 0-24 hours postoperatively
Time in hours from completion of the popliteal sciatic nerve block to the first administration of rescue analgesic medication. Rescue analgesia will be provided when the FLACC pain score is ≥ 4, or upon patient/parent request. This measure reflects the duration of effective postoperative analgesia provided by the nerve block.
次要结局
- FLACC Pain Scores at Rest(2 hours postoperatively)
- FLACC Pain Scores at Rest(4 hours postoperatively)
- FLACC Pain Scores at Rest(8 hours postoperatively)
- FLACC Pain Scores at Rest(12 hours postoperatively)
- FLACC Pain Scores During Movement(2 hours postoperatively)
- FLACC Pain Scores During Movement(4 hours postoperatively)
- FLACC Pain Scores During Movement(8 hours postoperatively)
- FLACC Pain Scores During Movement(12 hours postoperatively)
- Incidence of Persistent Sensory or Motor Deficit (Nerve Injury Screening)(1 week postoperatively)
- Total Opioid Consumption(0-24 hours postoperatively)
- FLACC Pain Scores at Rest(24 hours postoperatively)
- FLACC Pain Scores During Movement(24 hours postoperatively)
- Incidence of Adverse Events(0-24 hours postoperatively)
- Incidence of Persistent Sensory or Motor Deficit (Nerve Injury Screening)(1 month postoperatively)