Wound Infiltration with Dexmedetomidine in Cesarean Section: Effect on Postoperative Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
The effects of four different wound infiltration protocols in cesarean section will be investigated on parturient' pain intensity, PCA morphine consumption given, side effects and parturient' overall satisfaction.
One group will receive for wound infiltration dexmedetomidine, the second ropivacaine, the third dexmedetomidine combined with ropivacaine, while the last one will receive normal saline (placebo group).
详细描述
Parturients undergoing scheduled cesarean section under combined spinal-epidural anesthesia will be included in the study. Women will be randomly allocated according to the type of the solution used for wound infiltration into one of the following four groups using the closed envelop method.
Group DEX: Following the closure of the uterine incision and the rectus fascia, 20 mL solution of dexmedetomidine 1γ/kg within Normal Saline will be infiltrated subcutaneously along the skin wound edges.
Group ROPI: Following the closure of the uterine incision and the rectus fascia, 20 mL solution of ropivacaine 0.375% will be infiltrated subcutaneously along the skin wound edges.
Group DEX-ROPI: Following the closure of the uterine incision and the rectus fascia, 20 mL solution of dexmedetomidine 1γ/kg within ropivacaine 0.375% will be infiltrated subcutaneously along the skin wound edges.
Placebo Group: Following the closure of the uterine incision and the rectus fascia, 20 ml with 0.9 % saline solution will be infiltrated subcutaneously along the skin wound edges.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnancy >37 weeks, ASA I-II, BMI<35
排除标准
- •patient refusal, epilepsy, GERD, morbid obesity, drug allergy, ASA class >2, presence of atrioventricular block, severe systemic disease, multiple gestation, high risk pregnancy, contraindications to epidural technique, a history of severe systemic disease, recreational drug or alcohol use
研究组 & 干预措施
Dexmedetomidine
Drug: dexmedetomidine (Dexmed) 20 mL solution of dexmedetomidine used for wound infiltration
干预措施: Dexmedetomidine (Drug)
Ropivacaine
Drug: ropivacaine 20 mL solution of ropivacaine 0.375% used for wound infiltration
干预措施: Ropivacaine (Drug)
Dexmedetomidine - Ropivacaine
Drug: dexmedetomidine (Dexmed) combined with Drug: ropivacaine 20 mL solution of dexmedetomidine 1γ/kg within ropivacaine 0.375% used for wound infiltration
干预措施: Dexmedetomidine - Ropivacaine (Drug)
0.9 % saline
Drug:0.9 % saline solution (Normal saline). 20 ml with 0.9 % saline solution used for wound infiltration
干预措施: 0,9% saline (Other)
结局指标
主要结局
Pain score
时间窗: up to 24 hours after the end of surgery
Postoperative pain will be assessed in rest and mobilization using the Visual Analogue Scale (VAS, 0-10)
次要结局
- overall patient satisfaction(24 hours after the end of surgery)
- morphine consumption(24 hours after the PCA device initiation will be recorded)
研究者
Paraskevi Matsota
Assoc Prof of Anaesthesiology
Attikon Hospital