A Pilot Study Comparison of Postoperative Analgesia Using Two Modes of Local Anesthetic Epidural Delivery After Bladder Exstrophy Repair: Programmed Intermittent Bolus Versus Continuous Infusion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Postoperative pain score
研究概览
简要总结
The purpose of this study is to determine whether programmed intermittent epidural bolus (PIEB) offers advantages over continuous epidural infusion (CEI) in this pediatric post-surgical population by randomizing patients to receive either the PIEB or CEI pump modality for postoperative analgesia. The comparative efficacy of the two interventions will be primarily determined by assessing pain scores at frequent intervals in the first three postoperative days. Secondary outcomes examined over this period will include opioid consumption, number of epidural pump interventions, incidence of epidural insertion site leakage and/or early catheter discontinuation, time to full diet, and incidence of postoperative hypotension.
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
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age less than 18 years
- •Kelly procedure or other approximating surgical interventions
- •Expected need for postoperative epidural analgesia of at least 72 hours in duration
排除标准
- •Spine abnormality or coagulopathy that contraindicates epidural catheter placement
- •Perioperative anticoagulation regimen that is not recommended by the ASRA guidelines on concurrent use with neuraxial anesthesia
- •Surgery is anticipated to require osteotomies
- •Allergy to local anesthetic drug or other pain management drugs listed in protocol
- •Allergy to chlorhexidine, Dermabond, or Tegaderm CHG dressing
- •Opioid consumption within two weeks prior to surgery
- •Infection or rash over the epidural catheter insertion site
- •Systemic bacterial or fungal infection requiring ongoing treatment with antibiotics
- •Epidural pump unable to be initiated in the operating room or within 30 minutes of arrival to PACU.
研究组 & 干预措施
Continuous epidural infusion (CEI)
A continuous infusion of anesthetic medication through an epidural catheter.
干预措施: Ropivacaine (Epidural analgesia) continuous infusion (Drug)
Continuous epidural infusion (CEI)
A continuous infusion of anesthetic medication through an epidural catheter.
干预措施: Chloroprocaine continuous infusion (Drug)
Programmed intermittent epidural bolus (PIEB)
Administering boluses of anesthetic medication through an epidural catheter on a scheduled interval without patient involvement.
干预措施: Ropivacaine (Epidural analgesia) intermittent bolus (Drug)
Programmed intermittent epidural bolus (PIEB)
Administering boluses of anesthetic medication through an epidural catheter on a scheduled interval without patient involvement.
干预措施: Chloroprocaine intermittent bolus (Drug)
结局指标
主要结局
Postoperative pain score
时间窗: 72 hours after surgery
Average pain score after surgery
次要结局
- Postoperative opioid consumption(72 hours after surgery)
- Epidural leakage(72 hours after surgery)
- Hypotension(72 hours after surgery)
研究者
Giorgio Veneziano
Medical Director, Comprehensive Pain Services
Nationwide Children's Hospital