Assessing the Impact of the Number of Opiates Prescribed on Post Cesarean Pain Control: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- The primary outcome is the percent of patients who refill their narcotic prescription after cesarean delivery. .
研究概览
简要总结
The purpose of this randomized trial is to examine whether the number of opioid pills prescribed for pain control after Cesarean section has an effect on patient reported pain levels and satisfaction with pain control during recovery. Both groups receive what is considered an adequate number of pills for pain control after an uncomplicated Cesarean delivery. Secondarily, the investigators wish to gather reliable information about the duration of use of opioids for pain control after uncomplicated Cesarean section, and what happens to unused medication.
After an uncomplicated Cesarean section, patients will be approached and asked to participate in the study. If the patient agrees, she will be randomly assigned to one of the two study groups and receive a prescription for opioid medication at the time of hospital discharge. At her standard care follow-up visit 10-14 days later, the participant will complete a survey asking questions about her pain levels during recovery, her use of study-related and non-study-related pain medication, and satisfaction with pain control. At that point the patient's participation in the study will end.
详细描述
Study Design and Methods:
The investigators will conduct a randomized controlled trial evaluating the difference in postpartum pain control in women receiving two different amounts of oxycodone after cesarean delivery.
Primary outcomes
• The primary outcome is the percent of patients who refill their narcotic prescription after cesarean delivery.
Secondary outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Participants and investigators will be aware of the arm to which they have been assigned.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18-45 years
- •English, Somali or Spanish Speaking
- •Status post uncomplicated cesarean delivery performed at term (37w 0d to 42w 0d at time of delivery)
- •Discharged at day 3 or 4 after cesarean section
- •Willingness to participate in a survey 10-14 days post cesarean
排除标准
- •History of or current narcotic abuse
- •History of chronic pain
- •History or current opiate addiction
- •Complicated cesarean delivery including cesarean hysterectomy, EBL >1500 cc, bowel or bladder injury, postpartum infectious morbidity, postpartum wound break down
- •Neonatal outcome requiring NICU admission for more than 48 hours
结局指标
主要结局
The primary outcome is the percent of patients who refill their narcotic prescription after cesarean delivery. .
时间窗: 7-14 days after surgery
This outcome will be assessed by survey and confirmed with Ohio Automatic Rx Reporting System (OARRS) review performed on the same day as survey completion
次要结局
- Patient satisfaction with pain control after cesarean delivery(7-14 days after surgery)
- Amount of narcotic unused after cesarean delivery.(7-14 days after surgery)
- Duration of use of narcotic after cesarean(7-14 days after surgery)
- Disposition of unused drug(7-14 days after surgery)