Clinical trial NCT03623256: Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia
Official title: Comparison of Intrathecal Versus Epidural Fentanyl: Effect of Neuraxial Route of Administration on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Labor Pain
Obstetric Pain
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 558
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly assigned to one of four groups:

Group A: Spinal dose of preservative-free fentanyl 25 mcg. Group B: Spinal preservative-free 0.25% bupivacaine. Group C: Spinal combination of preservative-free 0.25% bupivacaine and fentanyl 25 mcg.

Group D: 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 30 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). We will also record level of insertion, blood pressure every 5 minutes, dermatomal level, pain level, patient satisfaction level and pruritus.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fetal heart rate
timeFrame: 20 minutes (Starting from placement of labor neuraxial block)
Secondary outcomes:
measure: Blood pressure
timeFrame: 20 minutes (Starting from placement of labor neuraxial block)
measure: Dermatomal level
timeFrame: 20 minutes (Starting from placement of labor neuraxial block)
measure: Maternal Pain level: visual analogue scale
timeFrame: 20 minutes (Starting from placement of labor neuraxial block)
measure: Patient satisfaction level: Likert Scale
timeFrame: 20 minutes (Starting from placement of labor neuraxial block)
measure: Uterine tone
timeFrame: 20 minutes (Starting from placement of labor neuraxial block)
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
Study officials:
affiliation: Augusta University
name: Efrain Riveros Perez, MD
role: PRINCIPAL_INVESTIGATOR
References: