Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cardiology, Women's Studies |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/29/2018 |
| Start Date: | April 1, 2019 |
| End Date: | October 31, 2021 |
| Contact: | Efrain Riveros Perez, MD |
| Email: | eriverosperez@augusta.edu |
| Phone: | 7067217361 |
Comparison of Intrathecal Versus Epidural Fentanyl: Effect of Neuraxial Route of Administration on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia
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.
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.
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.
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.
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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