Evaluating Pain Control Strategies in Postpartum Patients on Opioid Use Disorder Medications: Efficacy and Safety Outcomes.
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of participants with Change in pain assessment scores from baseline post surgery
研究概览
简要总结
The purpose of this study is to investigate the efficacy of three different modalities of post-operative pain control in parturient with opioid use disorders. The investigators aim to determine whether the different approach utilized show better outcomes with pain management and if there are any association with reduction of symptoms of anxiety, depression, and overall well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria include being a parturient with Substance use disorder (SUD) and age 18-35
排除标准
- •Exclusion criteria include having a diagnosed medical condition(allergies to medication, pathology such as severe aortic stenosis excluding patients from receiving an epidural etc) that will exempt patient from intervention arm of the study.
研究组 & 干预措施
Transverse abdominal Plane(TAP) Block with long acting Exparel
A subset of participants (n=15) will be divided into three different arms: A.) Postoperative Epidural infusion for 24-36hrs B.) Hydromorphone Patient Controlled Analgesia (PCA) with Preservative free Morphine via epidural for 36hrs C.) Transverse abdominal Plane(TAP) Block with long acting Exparel.
干预措施: Regional Anesthesia (Drug)
Postoperative Epidural infusion for 24-36hrs
A subset of participants (n=15) will be divided into three different arms: A.) Postoperative Epidural infusion for 24-36hrs B.) Hydromorphone Patient Controlled Analgesia (PCA) with Preservative free Morphine via epidural for 36hrs C.) Transverse abdominal Plane(TAP) Block with long acting Exparel.
干预措施: Epidural local anesthetic infusion (Procedure)
Hydromorphone Patient Controlled Analgesia (PCA),Preservative free Morphine via epidural for 36hrs
A subset of participants (n=15) will be divided into three different arms: A.) Postoperative Epidural infusion for 24-36hrs B.) Hydromorphone Patient Controlled Analgesia (PCA) with Preservative free Morphine via epidural for 36hrs C.) Transverse abdominal Plane(TAP) Block with long acting Exparel.
干预措施: Hydromorphone Patient Controlled Analgelsic (Drug)
结局指标
主要结局
Number of participants with Change in pain assessment scores from baseline post surgery
时间窗: immediately after the study intervention and up to post op day 2
Number of participants with significant change in pain assessment scores and any association with reduction of symptoms of anxiety, depression, and overall well-being.
次要结局
未报告次要终点
研究者
Christopher Fadumiye
Assistant Professor
Medical College of Wisconsin