NCT01211431撤回4 期
Post-cesarean Pain Control Via Continuous Infusion of Ropivacain et Diclogenac Into the Wound Versus Intathecal Morphine: Comparison of the Quality of Analgesia, Side Effects, and the Incidence of Residual Scar Pain
Centre Hospitalier Universitaire de Nīmes0 个研究点开始时间: 2010年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- Primary VAS score
研究概览
简要总结
The goal is to compare the quality of post-cesarean analgesia, the side effects and the incidence of residual scar pain obtained with intrathecal morphine (reference treatment) or with a continuous intra-wound solution including both ropivacain and diclofenac (experimental treatment).
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
- None
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
- •single, normally progressing pregancy
- •term > 36 weeks amenorrhea
- •BMI between 20 and 25 kg/m^2 before pregnancy
- •height between 55 and 90 kg
- •cesarean section by Joel-Cohen or Pfannenstiel techniques
- •patient has signed consent
- •patient has social security coverage
排除标准
- •Multiple pregnancy
- •pathological pregnancy: hypertension (>140/90 mmHg found during the pregnancy), pre-eclampsia, gestational diabetes
- •term < 36 weeks amenorrhea
- •non-pregnancy related maternal pathology (insufficiency)
- •obesity (BMI > 25 kg/m^2 before pregnancy)
- •height < 155 cm or > 180 cm
- •weight < 55 kg or > 90 kg
- •patient refuses to sign consent
- •surgical technique other than Joel-Cohen or Pfannenstiel
- •hepatic insufficiency (prothrombin < 60%)
- •contra-indications for rachianesthesia: infection, hemostasis problems (platelets < 80.109/L, prothrombin < 60%, TCA > 40s)
- •allergy to local anesthestics
- •patient is participating in another study, or has participated in another study within the last 6 months
- •patient is under any type of guardianship
研究组 & 干预措施
Reference
Active Comparator
Intrathécale morphine is used for post-cesarean pain control
干预措施: Reference (Drug)
Experimental
Experimental
A solution including both ropivacain and diclofenac continuously delivered to the wound is used for post-cesarean pain control
干预措施: Experimental (Drug)
结局指标
主要结局
Primary VAS score
时间窗: 36 hours post delivery
The patient is asked to evaluate cesarean-section related pain using a visual analog scale (VAS) score for pain on a scale of 1-10 in a sitting position.
次要结局
未报告次要终点
研究者
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