Impact of Local Anesthetic Wound Infiltration on Postoperative Pain Following Cesarean Delivery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Pain Score on Movement (Sitting in Bed From a Supine Position)
研究概览
简要总结
The purpose of this study is to determine if the infusion of the local anesthetic ropivacaine (a numbing medicine) and the non-steroidal anti-inflammatory drug ketorolac (a pain killer similar to ibuprofen) through a catheter placed along the cesarean delivery incision, will reduce the pain experienced after cesarean section and need for narcotic pain medicine.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology (ASA) class 1,2, and 3
- •English speaking women at a gestational age > 37 weeks
- •scheduled for cesarean delivery under spinal or combined spinal epidural anesthesia
排除标准
- •BMI > 50 kg/m2
- •history of intravenous drug or opioid abuse
- •previous history of chronic pain syndrome
- •history of opioid use in the past week
- •allergy or contraindication to any of the study medications
- •non-English speaking
研究组 & 干预措施
Ropivacaine
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
干预措施: Ropivacaine (Drug)
Ropivacaine
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
干预措施: Ketorolac (Drug)
Placebo
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
干预措施: Placebo (Drug)
结局指标
主要结局
Pain Score on Movement (Sitting in Bed From a Supine Position)
时间窗: 24 hours after surgery
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
次要结局
- Time to First Rescue Analgesic(48 hours)
- Number of Subjects Experiencing Nausea(48 hours)
- Patient Satisfaction With Postoperative Analgesia on a 0-10 Scale(48 hours)
- Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale(6 months)
- Pain Score on Movement(48 hours after surgery)
- Pain Scores at Rest(48 hours)
- Opioid Consumption(48 hours)
- Number of Subjects Experiencing Pruritus(48 hours)
- Number of Subjects Experiencing Vomiting(48 hours)
- Number of Subjects With Chronic Pain(6 months)