A Prospective, Randomized, Double-blind Trial of the Impact of Intraoperative Intravenous Lidocaine Infusion on Total Opioid Requirements in Children Undergoing Surgical Fixation of Upper Extremity Long Bone Fractures Under General Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Total perioperative opioid consumption
研究概览
简要总结
This study is a prospective, randomized, double-blind clinical trial evaluating whether intraoperative intravenous lidocaine infusion (IVLI) reduces opioid requirements and improves postoperative pain control in children undergoing surgical fixation of upper extremity long bone fractures under general anesthesia. Ninety pediatric patients, ages 3-18 will be enrolled and randomized 1:1 to receive either IV lidocaine or placebo (normal saline) during surgery.
All participants will receive standardized anesthesia care and postoperative pain management. Opioid consumption and pain scores will be measured intraoperatively and throughout the postoperative recovery, with the primary outcome focused on total opioid use 60 minutes after arrival to the post-anesthesia care unit (PACU). Secondary outcomes include opioid use at additional time points, postoperative pain scores, PACU length of stay, rescue antiemetic use and the relationship between infusion duration and outcomes.
Patients will be closely monitored for signs of local anesthetic systemic toxicity and other adverse events. The goal of this study is to determine whether IV lidocaine is an effective opioid-sparing adjunct in pediatric orthopedic surgery and to support safer, multimodal analgesia 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
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 3-18 years
- •Patients > 10 kg
- •Patients who present to Nemours Children's Hospital - Delaware Valley (NCH-DE) for surgical fixation of upper extremity fractures from distal humerus to distal radius
排除标准
- •Children < 3 years or > 18 years
- •Patients with allergy to local anesthetics
- •Patients who are eligible for an receive a peripheral nerve block
- •Patients with multi-trauma or open fractures
- •Patients with previous history of seizure disorder
- •Patients with conduction abnormalities or cardiac arrhythmia requiring chronic treatment
- •Patients on strong CYP450 inhibitors (fluvoxamine, erythromycin, ciprofloxacin, rifampin, allopurinol, ketoconazole, itraconazole)
- •Patients with chronic kidney or liver dysfunction
- •Patients with planned use of continuous infusion pain medications (opioids, ketamine, alpha-2- agonists)
- •Patients with positive pregnancy test prior to surgery or nursing mothers
- •Patients who parents decline enrollment
研究组 & 干预措施
Patients receiving placebo
干预措施: Standard of Care (SOC) (Other)
Patients receiving lidocaine infusion
干预措施: Lidocaine Infusion (Drug)
结局指标
主要结局
Total perioperative opioid consumption
时间窗: 60 minutes after patient arrival to post-anesthesia care unit (PACU)
Determine the effect of IVLI on intraoperative and postoperative opioid consumption in pediatric patients undergoing orthopedic surgery for long bone fractures of the upper extremity
次要结局
- Postoperative pain scores(30, 60, 90 minutes and the time when patient meets Phase 1 PACU discharge criteria.)
- Rescue Anti-Emetic Use(Duration of Phase 1 PACU length of stay)
- Infusion and Surgical Length(60 minutes after patient arrives in post-anesthesia care unit (PACU))
研究者
Angela Snow
Pediatric Anesthesiologist
Nemours Children's Clinic