Ropivacaine Through Continuous Infusion Versus Epidural Morphine for Postoperative Analgesia After Emergency Cesarean Section (ROMANCE)
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.
研究概览
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Grenoble、法国
- Hôpital Couple Enfant - CHU de Grenoble
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Continuous wound infusion group
Patients receive analgesia through a multiorifice wound catheter connected to ropivacaine infusion.
Saline solution is given in the epidural bolus.
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有源比较器：Epidural morphine group
Patients receive epidural analgesia through an epidural bolus of morphine.
Saline solution is perfused through the wound catheter.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain score during mobilization
大体时间：at 24 hours
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Visual analog scale for pain while the patient moves from lying to sitting
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at 24 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain score at rest
大体时间：at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
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Visual analog scale for pain while the patient is at rest
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at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
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Pain score during mobilization
大体时间：at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
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Visual analog scale for pain while the patient moves from lying to sitting
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at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
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The incidence of morphine side effects: nausea, vomiting, pruritus
大体时间：at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
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At every time points, side effects will be recorded
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at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
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Duration of Indwelling Urethral Catheters
大体时间：at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
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At ever time points, the presence of urethral catheter will be recorded and total duration will be compared.
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at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
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Recovery of bowel function
大体时间：at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
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At ever time points, patients will be asked whether they recovered bowel function and total duration to recover bowel function will be compared.
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at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
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Morphine consumption dose
大体时间：During hospital stay (an average of 3 days)
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Total dose of morphine consumed for pain management after the epidural bolus
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During hospital stay (an average of 3 days)
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Parturient satisfaction score
大体时间：at 48 hours
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Satisfaction about pain management and breastfeeding
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at 48 hours
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Complications during wound-catheter removal
大体时间：at 48 hours
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Fever, pain, difficulties and infection at removal
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at 48 hours
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Delay between birth and breastfeeding
大体时间：During hospital stay (an average of 3 days)
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During hospital stay (an average of 3 days)
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Duration of stay
大体时间：Hospital stay (an average of 3 days)
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Hospital stay (an average of 3 days)
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Residual pain
大体时间：3 months
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Numeric Rating Scale for Pain by phone interview
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3 months
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合作者和调查者
出版物和有用的链接
一般刊物
- Palmer CM, Nogami WM, Van Maren G, Alves DM. Postcesarean epidural morphine: a dose-response study. Anesth Analg. 2000 Apr;90(4):887-91. doi: 10.1097/00000539-200004000-00021.
- Fuller JG, McMorland GH, Douglas MJ, Palmer L. Epidural morphine for analgesia after caesarean section: a report of 4880 patients. Can J Anaesth. 1990 Sep;37(6):636-40. doi: 10.1007/BF03006481.
- Bamigboye AA, Hofmeyr GJ. Local anaesthetic wound infiltration and abdominal nerves block during caesarean section for postoperative pain relief. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD006954. doi: 10.1002/14651858.CD006954.pub2.
- Mecklem DW, Humphrey MD, Hicks RW. Efficacy of bupivacaine delivered by wound catheter for post-Caesarean section analgesia. Aust N Z J Obstet Gynaecol. 1995 Nov;35(4):416-21. doi: 10.1111/j.1479-828x.1995.tb02156.x.
- Ranta PO, Ala-Kokko TI, Kukkonen JE, Ohtonen PP, Raudaskoski TH, Reponen PK, Rawal N. Incisional and epidural analgesia after caesarean delivery: a prospective, placebo-controlled, randomised clinical study. Int J Obstet Anesth. 2006 Jul;15(3):189-94. doi: 10.1016/j.ijoa.2006.02.003.
- O'Neill P, Duarte F, Ribeiro I, Centeno MJ, Moreira J. Ropivacaine continuous wound infusion versus epidural morphine for postoperative analgesia after cesarean delivery: a randomized controlled trial. Anesth Analg. 2012 Jan;114(1):179-85. doi: 10.1213/ANE.0b013e3182368e87. Epub 2011 Oct 24.
- Siddik SM, Aouad MT, Jalbout MI, Rizk LB, Kamar GH, Baraka AS. Diclofenac and/or propacetamol for postoperative pain management after cesarean delivery in patients receiving patient controlled analgesia morphine. Reg Anesth Pain Med. 2001 Jul-Aug;26(4):310-5. doi: 10.1053/rapm.2001.21828.
- Rackelboom T, Strat SL, Silvera S, Schmitz T, Bassot A, Goffinet F, Ozier Y, Beaussier M, Mignon A. Improving continuous wound infusion effectiveness for postoperative analgesia after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2010 Oct;116(4):893-900. doi: 10.1097/AOG.0b013e3181f38ac6.
研究记录日期
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学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
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首次发布 (估计)
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