Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery : A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pain at rest
研究概览
简要总结
Cesarean delivery is one of the most common surgical procedures, performed at an increasingly high rate. It is associated with intense postoperative pain that may hamper the rehabilitation process and interfere with patient satisfaction and care provided to the newborn. Therefore, control of perioperative pain with multimodal regimens using local anesthetic may be important in short- and long-term convalescence after surgery.
Opioid-based regimens are the "gold standard" of cesarean delivery analgesia. However, spinal and epidural opioids have a ceiling effect.
Wound infiltration with local anesthetics has been used widely in the multimodal approach of pain relief. Continuous wound infusion with local anesthetic through a multiorifice catheter increases the duration of action and efficacy of local surgical wound infiltration compared with a one-time wound injection of local anesthetic.
After cesarean delivery, Local anesthetic continuous wound infusion would be associated with better reduction in pain scores when compared to intrathecal morphine . Therefore, an assessor and patient blinded, randomized study that aimed to compare the efficacy and side effects of these analgesia techniques was conducted.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
healthy, term women scheduled for cesarean delievry
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age between 18 and 50 years.
- •gestational age 37 to 42 weeks.
- •body mass index ranging from 18.0 to 30.0 kg/m2
- •American Society of Anesthesiology (ASA) physical status I or II
- •elective cesarean delivery with a Pfannenstiel incision
- •spinal anesthesia.
排除标准
- •history of chronic opioid use.
- •Allergy to opioids and or local anesthetics.
- •absolute or relative contraindication to neuraxial anesthesia.
- •fever or any other sign of infection.
- •Diabetes Mellitus under insulin therapy
- •physical separation of patients from the neonate during the postoperative period.
研究组 & 干预措施
Placebo (P)
Placebo group parturients will receive spinal anesthesia with intrathecal morphine and will have continuous normal saline wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain).
干预措施: wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain) (Device)
Placebo (P)
Placebo group parturients will receive spinal anesthesia with intrathecal morphine and will have continuous normal saline wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain).
干预措施: Spinal Anesthesia (Procedure)
Placebo (P)
Placebo group parturients will receive spinal anesthesia with intrathecal morphine and will have continuous normal saline wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain).
干预措施: intrathecal morphine (Drug)
Placebo (P)
Placebo group parturients will receive spinal anesthesia with intrathecal morphine and will have continuous normal saline wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain).
干预措施: Normal saline (Drug)
Ropivacaine (R)
Ropivacaine group parturients will receive spinal anesthesia without intrathecal morphine and will have continuous ropivacaine (Ropivacaina Molteni®) wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain).
干预措施: wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain) (Device)
Ropivacaine (R)
Ropivacaine group parturients will receive spinal anesthesia without intrathecal morphine and will have continuous ropivacaine (Ropivacaina Molteni®) wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain).
干预措施: Spinal Anesthesia (Procedure)
Ropivacaine (R)
Ropivacaine group parturients will receive spinal anesthesia without intrathecal morphine and will have continuous ropivacaine (Ropivacaina Molteni®) wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain).
干预措施: Ropivacaine (Ropivacaina Molteni®) (Drug)
结局指标
主要结局
pain at rest
时间窗: Hour 48
Pain scores at rest were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain.Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
次要结局
- pain at mobilization(Hour 48)
- incidence of postoperative nausea and vomiting(Hour 48)
- incidence of pruritus(Hour 48)
- incidence of urinary retention(during the 48 hours postoperatively)
- return of gastrointestinal function(during the 48 hours postoperatively)
- sedation(Hour 48)
- incidence of neurological alterations(Hour 48)
研究者
Hicham Abou Zeid
Assistant Professor
Saint-Joseph University