Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-03-04 @ 2:54 PM
Study NCT ID:
NCT03623256
Status:
UNKNOWN
Last Update Posted:
2021-07-22
First Post:
2018-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia
Sponsor:
Augusta University
Organization:
Study Overview
Official Title:
Comparison of Intrathecal Versus Epidural Fentanyl: Effect of Neuraxial Route of Administration on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: