Ropivacaine Through Continuous Infusion Versus Epidural Morphine for Postoperative Analgesia After Emergency Cesarean Section
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Pain score during mobilization
研究概览
简要总结
The cesarean section is one of the most commonly performed surgeries in the world and it represents 20% of the births in France. Postoperative pain is moderate-to-severe during the first 48 hours after this procedure. Thereby its control is prominent for the medical team in order to shorten the duration of hospital stay as well as to permit an early return to daily activities for these surgical patients.
Pain control after cesarean section is usually based on non-opioids and epidural administration of morphine if an epidural catheter has been previously placed for the procedure. However epidural morphine is associated with a number of side effects. Wound infiltration with local anesthetics has been widely used in the multimodal management of postoperative pain and it may reduce postoperative morphine consumption.
In patients enrolled for emergency cesarean delivery with epidural catheter, the objective of this study will be to compare the analgesia provided by a local anesthetic wound 48-hours infusion through a multiorifice catheter (ropivacaine 2 mg/mL) versus epidural analgesia (epidural morphine bolus). Quality of pain control will be assessed with the measurements of morphine consumption and pain scores at rest and during mobilisation over 48 hours. At 3 months, patients will be interviewed to assess their residual pain and their satisfaction.
It is hypothesized that local anesthetic wound infusion would be non-inferior than epidural morphine analgesia to control pain after cesarean section, and be associated with a reduction of side effects related to the analgesics.
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
- Single (Participant)
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
- •Minimum age 18 years
- •ASA-1 and 2 Parturient
- •Emergency Cesarean delivery under epidural anesthesia
- •Suprapubic incision used for cesarean section
- •Functional epidural Catheter before the cesarean decision
- •(ASA Scores : Physical Status score)
排除标准
- •ASA-3 and 4 Parturient
- •BMI > 35 (before pregnancy)
- •Existing chronic pain
- •Contra-indication to study treatments
- •Chronic use of analgesics or morphinic
- •Preeclampsia
- •Infection
- •< 37 weeks pregnant +/- 3 days
研究组 & 干预措施
Continuous wound infusion group
Patients receive analgesia through a multiorifice wound catheter connected to ropivacaine infusion. Saline solution is given in the epidural bolus.
干预措施: Ropivacaine (Drug)
Epidural morphine group
Patients receive epidural analgesia through an epidural bolus of morphine. Saline solution is perfused through the wound catheter.
干预措施: Morphine (Drug)
结局指标
主要结局
Pain score during mobilization
时间窗: at 24 hours
Visual analog scale for pain while the patient moves from lying to sitting
次要结局
- Pain score at rest(at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h))
- Parturient satisfaction score(at 48 hours)
- Delay between birth and breastfeeding(During hospital stay (an average of 3 days))
- Duration of stay(Hospital stay (an average of 3 days))
- Complications during wound-catheter removal(at 48 hours)
- Pain score during mobilization(at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h))
- The incidence of morphine side effects: nausea, vomiting, pruritus(at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h))
- Duration of Indwelling Urethral Catheters(at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h))
- Recovery of bowel function(at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h))
- Morphine consumption dose(During hospital stay (an average of 3 days))
- Residual pain(3 months)