Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia

  • End date
    Oct 31, 2023
  • participants needed
  • sponsor
    Augusta University
Updated on 2 March 2022
epidural analgesia
pain relieving
fetal bradycardia


There have been studies reporting that combined spinal-epidural (CSE) with fentanyl and bupivacaine produce fetal bradycardia, (M.Kuczkowski, 2004) (Abro 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.


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.

Condition Labor Pain, Obstetric Pain
Treatment Spinal fentanyl, Spinal bupivacaine, Spinal Fentanyl and Bupivacaine, Epidural fentanyl /spinal bupivacaine
Clinical Study IdentifierNCT03623256
SponsorAugusta University
Last Modified on2 March 2022


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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