Effect of Intrathecal Morphine on Urinary Bladder Function and Recovery in Patients Having a Cesarean Delivery - A Double-blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Debimetry
研究概览
简要总结
The enhanced recovery anesthesia concept has been widely adopted, including cesarean delivery. Modern obstetrical anesthesia aims to offer an experience to a patient undergoing a cesarean delivery similar to normal vaginal delivery in order to maximize postoperative comfort and facilitate bonding between the mother and her newborn. Therefore, early removal of the bladder catheter has been recommended. However, this is challenged by the administration of intrathecal morphine recommended to provide long-lasting postoperative analgesia after cesarean delivery.
详细描述
This double-blind, randomized trial investigates the effects of intrathecal morphine on urinary dynamics in women undergoing CD under spinal anesthesia. The hypothesis is that the addition of intrathecal morphine (ITM) will delay micturition in women undergoing cesarean delivery. The primary outcome is the effect of ITM on urodynamics the difference in time to micturition. The secondary outcome is the need for bladder re-catheterization.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Patient assessments and bladder urodynamic data collection were performed by two blinded anesthesiologists.
Randomization was performed using the sealed envelopes method. Therefore, one of the anesthesiologists of the research team, who was unblinded, opened the envelopes and prepared the injection mixtures.
Another two blinded anesthesiologists administered perioperative anesthesia and monitored the patient during the perioperative period, and evaluated sensitive and motor block.
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
- •ASA physical status I and II
- •Term singleton pregnancies
- •Elective cesarean delivery under spinal anesthesia
- •Between October 2021 and March 2022
排除标准
- •Pre-existing or gestational hypertension
- •Cardiovascular disease
- •Cerebrovascular disease
- •Known fetal abnormalities
- •Extremes of weight (<40 kg or > 100 kg)
- •Contraindications to neuraxial anesthesia
- •Twin pregnancies
- •Excessive intraoperative bleeding (blood loss exceeding > 1000 mL or requiring a blood transfusion)
研究组 & 干预措施
Morphine
50 mg prilocaine + 2.5 mcg sufentanil + 100 mcg morphine (0.1ml)
干预措施: 100 mcg morphine (Drug)
Morphine
50 mg prilocaine + 2.5 mcg sufentanil + 100 mcg morphine (0.1ml)
干预措施: 50 mg prilocaine + 2.5 mcg sufentanil (Drug)
NaCl 0.9%
50 mg prilocaine + 2.5 mcg sufentanil + 0.1 ml saline
干预措施: 0.9% NaCl (Drug)
NaCl 0.9%
50 mg prilocaine + 2.5 mcg sufentanil + 0.1 ml saline
干预措施: 50 mg prilocaine + 2.5 mcg sufentanil (Drug)
NaCl 0.9%
50 mg prilocaine + 2.5 mcg sufentanil + 0.1 ml saline
干预措施: bilateral transverse abdominal plane block (Procedure)
结局指标
主要结局
Debimetry
时间窗: until the end of the study, an average of 6 months
Vesicle function 3
First micturition (hours)
时间窗: until the end of the study, an average of 6 months
Vesicle function 1
Bladder volume (mL)
时间窗: until the end of the study, an average of 6 months
Vesicle function 2
次要结局
- Bladder re-catherization(until the end of the study, an average of 6 months)
研究者
Jean François Brichant
Principal investigator
University of Liege