Improving ObsQoR-11 With Continuous Wound Infusion Versus Intrathecal Morphine After Elective Cesarean Delivery: A Randomized Double-Blinded Controlled Trial Targeting Patients' Recovery and Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- ObsQoR-11 at 24 hours
研究概览
简要总结
The purpose of this prospective randomized double-blinded and controlled study is to evaluate the quality of recovery after elective cesarean delivery using the Obstetric Quality-of-Recovery-11 (ObsQoR-11) score at 24 hours between patients receiving intrathecal morphine (ITM group) compared to patients receiving a ropivacaine continuous wound infusion (CWI group).
详细描述
Background:
Cesarean delivery (CD) is one of the most frequently practiced surgeries in the world. Most anesthetic techniques include the use of intrathecal morphine for post-operative analgesia. While it is the gold standard, it still carries significant side effects. Recently, other analgesic options have been evaluated. Continuous anesthetic wound infusion can provide satisfactory analgesia without intrathecal morphine administration. Quality of recovery and patients' satisfaction are patients'-oriented outcomes which are now recommended as primary aim in clinical research. However, most of previous studies evaluating different post-operative analgesia management in cesarean delivery have focused primarily only on pain scores or opioid consumption, which were not always clinically relevant even if some statistical difference was reported between groups. A new scoring tool, ObsQoR-11, have recently been validated for evaluating recovery after cesarean delivery. The goal of the present study is to demonstrate an improvement in the quality of recovery after cesarean delivery as well as in patients' satisfaction when ropivacaine continuous wound infusion is used compared to the standard management with intrathecal morphine.
Hypothesis:
The investigators hypothesized that the use of ropivacaine continuous wound infusion instead of intrathecal morphine for postoperative pain management will improve the ObsQoR-11 recovery score as well as patients' satisfaction after elective cesarean delivery.
Primary objective:
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, Investigator, Outcomes Assessor)
盲法说明
Only the anesthesiologist in charge in the operating room will be aware of treatment group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists status I and II
- •Maternal age above 18 years' old
- •Elective cesarean delivery
- •Spinal anesthesia
- •At least 37 weeks of gestational age
- •French-speaking patients (able to read and sign the consent form)
排除标准
- •Chronic pain
- •Chronic usage of any opioids
- •Cardiopathy
- •Unexpected difficult spinal anesthesia requiring general anesthesia or unsatisfactory sensory blockade
- •Unexpected complications requiring strong hemodynamic support (transfusions, volume challenges, multiple vasopressors, inotropic drugs...) or requiring anti-hypertensive medication (including magnesium)
- •Any contraindication (e.g. coagulopathy) or patient's refusal for spinal anesthesia
- •Morbid obesity (BMI > 40 at the time of delivery)
- •Active labour
- •Emergency CD
- •Fetal abnormality or prematurity (< 37 weeks of gestational age)
- •Multiple gestation
- •Inability to cooperate due to language or physical/mental incapacity
研究组 & 干预措施
Intrathecal Morphine (Control Group)
Spinal anesthesia with intrathecal morphine and postoperative continuous wound infusion with sterile saline.
干预措施: Intrathecal Morphine (Drug)
Continuous Wound Infusion (Intervention Group)
Spinal anesthesia without intrathecal morphine and postoperative continuous wound infusion with ropivacaine.
干预措施: Ropivacaine 0.2% (Drug)
结局指标
主要结局
ObsQoR-11 at 24 hours
时间窗: 24 hours after end of surgery
Quality of recovery after cesarean delivery using ObsQoR-11 score at 24 hours between patients receiving intrathecal morphine (ITM) compared to patients receiving a ropivacaine continuous wound infusion CWI)
次要结局
- ObsQoR-11 items(24, 48 and 72 hours after end of surgery)
- Global health score(24, 48 and 72 hours after end of surgery)
- ObsQoR-11 at 48 and 72 hours(48 and 72 hours after end of surgery)
- Pain scores(In postanesthesia care unit (PACU), at 2, 4, 6, 12, 24, 48, 72 hours and 5 and 7 days after the end of surgery)
- Nausea and vomiting score(At 2, 4, 6, 12, 24 hours after the end of surgery)
- Time to first mobilization with ambulation(During the first 24 hours after the end of surgery)
- Opioid consumption(In postanesthesia care unit (PACU), at 2, 4, 6, 12, 24, 48, 72 hours and 5 and 7 days after the end of surgery)
- Pruritus score(At 2, 4, 6, 12, 24 hours after the end of surgery)
研究者
Philippe Richebe
Director of Research, Principal Investigator, Anesthesiologist, Associate Professor, MD, PhD
Ciusss de L'Est de l'Île de Montréal