Randomized Trial Comparing the Injection of Intrathecal Fentanyl Versus Epidural Fentanyl for the Initiation of Labour Analgesia on the Incidence of Pruritis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pruritus
研究概览
简要总结
The purpose of this study is to investigate the effect of neuraxial analgesia initiation on the incidence of pruritus in laboring women. Specifically, this study aim to compare intrathecal fentanyl with epidural fentanyl in order to determine whether the epidural route is associated with a lower occurrence and severity of pruritus. By clarifying these differences, the research seek to optimize analgesic strategies during labor while minimizing opioid-related side effects
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, Investigator, Outcomes Assessor)
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
- •Age ≥ 18 years
- •Vaginal delivery
- •Gestational age ≥ 37 weeks
- •Requesting neuraxial analgesia
- •French or English language
排除标准
- •ASA score > 3
- •Allergy or contraindication to receiving opioids/local anesthesia (morphine or fentanyl)
- •BMI > 40 kg/m²
- •Hepatic or renal failure,
- •Severe preeclampsia and signs of severity according to the criteria of the American College of Obstetricians and Gynecologists
- •Maternal hemorrhage (placental abruption, hepatic subcapsular hematoma,...)
- •Severe scoliosis
- •Biliary cholestasis or polymorphic eruption of pregnancy
- •Inability to provide informed consent, either secondary to mental or physical disability or a significant language barrier (inability to understand English or French)
- •Prior administration of an opioid or opioid misuse
研究组 & 干预措施
Spinal
Intrathecal fentanyl This group will receive intrathecal Bupivacaïne 0.25% 1ml + Fentanyl 15mcg And epidural Nacl 0.9%
干预措施: Spinal analgesia (Procedure)
Epidural
Epidural fentanyl This group will receive intrathecal Bupivacaïne 0.25% 1ml + NaCl 0,9% And epidural fentanyl 100mcg
干预措施: Epidural Analgesia (Procedure)
结局指标
主要结局
Pruritus
时间窗: Every 15 minutes for the first hour, then every 30min for 2 hours until neuraxial analgesia
Incidence et severity * 4-point Likert scale: Absent, light, moderate, severe/unbearable. * number of patients treated by antipruritic (Naloxone)
次要结局
- Nausea Vomiting(2 hours until neuraxial analgesia)
- Hypotension(2 hours until neuraxial analgesia)
- Urinary rentention(24 hours until the neuraxial analgesia)
- Maternal satisfaction(24 hours until neuraxial analgesia)
- Fetal Bradycardia(2 hours until neuraxial analgesia)
研究者
Valerie Zaphiratos
Associate Professor of Anesthesiology
St. Justine's Hospital