Improving Pain Relief For Those Who Need It Most After Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Severity of Acute Pain
研究概览
简要总结
In previous studies the investigators have seen that the severity of pain one day after cesarean delivery can predict the presence of pain and depression 2 months later. The investigators believe those at risk for severe acute post-partum pain can be identified, and medical interventions can be tailored to manage postoperative pain more effectively.
详细描述
This study is randomizing patients into 2 different groups and seeing if by altering our pain management with this group of patients their acute 24 hour evoked pain is less than anticipated; and the incidence of persistent pain and depression when contacted 2 months after delivery is decreased. This study is designed to see if these additional interventions would prove effective for patients at risk of having high pain level after cesarean surgery.
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
- Double (Participant, Outcomes Assessor)
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
- •elective cesarean section
- •age >/= 18 years old
- •not allergic proposed study medications
- •predicted to experience high pain postop based on preoperative evaluation
排除标准
- •allergy to study medications
- •known hepatic disease
- •weight > 300 lbs
研究组 & 干预措施
Standard of care
Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
干预措施: Duramorph 150 (Drug)
Acetaminophen and increased dose of Duramorph
Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
干预措施: Acetaminophen (Drug)
Acetaminophen and increased dose of Duramorph
Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
干预措施: Duramorph 300 (Drug)
结局指标
主要结局
Severity of Acute Pain
时间窗: 24 hour
to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces acute post-delivery pain (24 hour evoked pain post delivery). The scale utilized was a 100mm sliding VAS, where 0mm=no pain up to 100mm-worst pain imaginable.
次要结局
- Analgesic Consumption(24 hour)
- Pain(24 hour)
- Average Pain Over 24 Hours(24 hours)
- Incidence of Persistent Pain(2 months)
- Incidence of Depression(2 months)