A Randomized Trial Evaluating Use of Long-Acting Liposomal Bupivacaine (Exparel®) in Reducing Narcotic Pain Requirements in Pediatric Patients Undergoing Minor Urologic Procedures
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Percentage of Patients Who Are Opiate-free
研究概览
简要总结
This study aims to evaluate the utility of long-acting liposomal bupivacaine (Exparel®) in improving pain scores and reducing narcotic pain requirements in pediatric patients following minor urologic procedures.
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients 6 years and older undergoing minor pediatric urologic surgery
- •Patients who are otherwise eligible to receive routine care following minor urologic surgery
排除标准
- •Contraindication to receiving local anesthetics (i.e. pre-existing cardiac, renal, hepatic dysfunction)
- •Pediatric patients younger than 6 years of age
- •Pediatric patients with a history of pain syndromes or are unable to tolerate opiate medication
- •Unwilling to participate in 48 hours and 10-14 day follow-up phone calls
研究组 & 干预措施
Liposomal Bupivacaine plus 0.25% Bupivacaine
Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine
干预措施: Exparel 133 miligrams per 10 milliliter injection (Drug)
Liposomal Bupivacaine plus 0.25% Bupivacaine
Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine
干预措施: Bupivacaine Hydrochloride (Drug)
0.25% Bupivacaine alone
Participants will receive local wound infiltration with 0.25% Bupivacaine alone.
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
Percentage of Patients Who Are Opiate-free
时间窗: 48 hours postoperatively
Percentage of patients who are opiate-free at 48 hours postoperatively.
Percentage of Patients Who Are Opiate-free at 10-14 Days Postoperatively
时间窗: 10-14 days postoperatively
Percentage of patients who are opiate-free at 10-14 days postoperatively.
Parents' Postoperative Pain Measure (PPPM) Scores
时间窗: 10-14 days postoperatively
15-item, yes/no behavioral checklist based on non-verbal pain cues children show following surgery. Scale is from 0 to 15, with higher scores denoting more severe pain. A score of 6+ has been validated as a threshold for a child experiencing clinically significant pain.
次要结局
- Percentage of Patients With Leftover Opioid Medication(10-14 days postoperatively)
- Amount of Opioid Medication Used Post-discharge(10-14 days postoperatively)
- Cumulative Incidence of Complications Related to Local Anesthetic Systemic Toxicity(10-14 days postoperatively)