Double Blind Randomized Trial of Post-operative Cesarean Continuous Infusion of Bupivacaine Versus Placebo for Local Incisional Pain Control
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total postoperative opioid use
研究概览
简要总结
This study plans to learn more about postoperative pain management after cesarean deliveries (C-sections). As a part of standard of care, the Children's Hospital Colorado's Colorado Fetal Care Center (CFCC) follows the standard Enhanced Recovery After Cesarean (ERAC) guidelines to manage pain following C-section delivery. In addition, the CFCC uses an FDA approved medical device called the ON-Q ® Pump, which continuously delivers local anesthetic medication to control pain in the area of your procedure. The local anesthetic used is bupivacaine, which is FDA approved for use to control local pain after C-sections. The CFCC has found a significant reduction in opioid use after adopting both of these procedures. The study aims to determine if the ERAC protocol or ON-Q ® Pump continuous infusion is responsible for lower opioid use by comparing bupivacaine (treatment) versus saline (placebo) groups.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant patients 18 years of age or older
- •Patients undergoing both scheduled and unscheduled cesarean deliveries at CFCC
排除标准
- •Active substance abuse (ex methamphetamines) determined by patient report, toxin screen, or screening physician's determination
- •Current treatment for chronic pain involving opiate receptor agonism or antagonism (i.e. suboxone, methadone, naltrexone, oxycodone)
- •Contraindication to neuraxial anesthesia
- •Known allergies to common anesthetic medications
- •Inability to consent to study procedures
- •Patient receiving general anesthesia
研究组 & 干预措施
Saline
ON-Q Pump® with continuous infusion of saline (270 mL of normal saline)
干预措施: ON-Q Pump® with continuous infusion of saline (Device)
Bupivacaine
ON-Q Pump® with continuous infusion of bupivacaine (270 ml of 0.5 % bupivacaine)
干预措施: ON-Q Pump® with continuous infusion of bupivacaine (Device)
结局指标
主要结局
Total postoperative opioid use
时间窗: Post-operative day 4
Total postoperative opioid use in morphine equivalents through discharge
次要结局
- Antiemetic use at hospital discharge (about post-operative day 5)(At hospital discharge (about post-operative day 5))
- Antiemetic use at Baseline(Baseline)
- Patient satisfaction survey with Visual Analog Scale (VAS) Pain Score(At hospital discharge (about post-operative day 5))
- Antiemetic use at post-operative day 4(Post-operative day 4)
- Visual Analog Scale (VAS) Pain Score at post-operative day 1(Post-operative day 1)
- Antiemetic use at post-operative day 2(Post-operative day 2)
- Antiemetic use at post-operative day 3(Post-operative day 3)
- Visual Analog Scale (VAS) Pain Score at Baseline(Baseline)
- Antiemetic use at post-operative day 1(Post-operative day 1)
- Visual Analog Scale (VAS) Pain Score at post-operative day 2(Post-operative day 2)
- Time to advance to regular diet(Up to post-operative day 4)
- Time to first ambulation(Up to post-operative day 4)
- Visual Analog Scale (VAS) Pain Score at post-operative day 3(Post-operative day 3)
- Visual Analog Scale (VAS) Pain Score at post-operative day 4(Post-operative day 4)
- Return on bowel function(Up to post-operative day 4)
- Edinburgh Depression scale at hospital discharge (about post-operative day 5)(At hospital discharge (about post-operative day 5))