Comparison of Intrathecal Versus Epidural Fentanyl: Effect of Neuraxial Route of Administration on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia
试验速览
- 阶段
- 4 期
- 入组人数
- 558
- 试验地点
- 1
- 主要终点
- Fetal heart rate
研究概览
简要总结
There have been studies reporting that combined spinal-epidural (CSE) with fentanyl and bupivacaine produce fetal bradycardia, (M.Kuczkowski, 2004) (Abrão K, 2009 ). It is unknown whether any differences in risk exist between fentanyl and bupivacaine when used as a part of the CSE procedure. Some authors have reported cases of parturients who developed uterine hyperactivity and fetal bradycardia after subarachnoid administration of fentanyl during labor. (D'Angelo & Eisenach, 1997) (Friedlander JD, 1997). It has been suggested that uterine hypertonus, leading to non-reassuring fetal heart rate tracings, might be an etiologic factor in these situations. (Landau, 2002).
We propose this study to test the hypothesis that administration of epidural fentanyl is associated with a lower incidence of fetal bradycardia compared to intrathecal fentanyl.
详细描述
After approval by the Institutional Review Board and written informed consent, we plan to prospectively study pregnant patients who undergo neuraxial labor analgesia. All patients will receive combined-spinal-epidural analgesia. Patients will be randomly assigned to one of four groups by means of sealed envelope technique. Group A will receive a spinal dose of preservative-free fentanyl 25 mcg. Group B will receive one dose of spinal preservative-free 0.25% bupivacaine. Group C will receive a spinal combination of preservative-free 0.25% bupivacaine and fentanyl 25 mcg. Group D will receive spinal preservative-free 0.25% bupivacaine and epidural fentanyl 100 mcg. After the procedure, we will monitor the fetal heart rate and tocometry tracings for 20 min. Thereafter, an epidural infusion with a solution containing 0.125% bupivacaine and 2mcg/mL of fentanyl will be started. We will record demographic variables (age, and BMI), obstetric variables (parity, gestational age, cervical dilation, oxytocin infusion) and anesthetic variables (level of insertion of epidural catheter).
Primary outcomes:
Fetal heart rate (baseline, minimal and abnormal patterns)
Secondary outcomes:
- Blood pressure (systolic, diastolic and mean) measured at baseline and every 5 minutes after administration of medication.
- Dermatomal level measured after 20 minutes of medication administration.
- Pain level (visual analogue scale) after 20 minutes of medication administration.
- Patient satisfaction level (1-10 scale) after 20 minutes of medication administration.
- Uterine tone measured with tocometer at baseline and during 20 minutes after medication administration.
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
- Single (Participant)
盲法说明
Participant will be blinded. The investigators will not be blinded because they are the same care providers. In addition, the volume of intrathecal anesthetic is different when bupivacaine plus fentanyl is used in comparison with only one medication used.
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
- •Older than 18 years
- •Term pregnancy (> 37 weeks)
- •Absence of obstetric morbidities
- •Active labor
- •Request of neuraxial analgesia per patient and/or obstetrician
- •Combined spinal-epidural technique
排除标准
- •Abnormal fetal heart rate tracing.
- •Uterine tachysystole before neuraxial analgesia.
- •Baseline blood pressure <90/60 mmHg.
- •Allergies to local anesthetics or fentanyl.
- •Maternal fever.
- •Pruritus before performance of neuraxial analgesia.
- •Contraindications for neuraxial technique.
- •Unwillingness to participate.
研究组 & 干预措施
Spinal Fentanyl
Spinal dose of preservative-free fentanyl 25 mcg (Volume 0.5 mL)
干预措施: Spinal fentanyl (Drug)
Spinal Bupivacaine
Spinal dose of preservative-free 0.25% bupivacaine (Volume 0.5 mL)
干预措施: Spinal bupivacaine (Drug)
Spinal Fentanyl and Bupivacaine
Spinal combination of preservative-free 0.25% bupivacaine (0.5 mL) and fentanyl 25 mcg (0.5 mL). (Total Volume 1 mL).
干预措施: Spinal Fentanyl and Bupivacaine (Drug)
Epidural fentanyl /spinal bupivacaine
Spinal preservative-free 0.25% bupivacaine (Volume 0.5 mL) and epidural fentanyl 100 mcg (Volume 2 mL).
干预措施: Epidural fentanyl /spinal bupivacaine (Drug)
结局指标
主要结局
Fetal heart rate
时间窗: 20 minutes (Starting from placement of labor neuraxial block)
Fetal bradycardia and abnormal fetal heart rate tracing
次要结局
- Blood pressure(20 minutes (Starting from placement of labor neuraxial block))
- Dermatomal level(20 minutes (Starting from placement of labor neuraxial block))
- Maternal Pain level: visual analogue scale(20 minutes (Starting from placement of labor neuraxial block))
- Patient satisfaction level: Likert Scale(20 minutes (Starting from placement of labor neuraxial block))
- Uterine tone(20 minutes (Starting from placement of labor neuraxial block))
研究者
Efrain Riveros Perez, MD
Assistant Professor Department of Anesthesiology and Perioperative Medicine
Augusta University