Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03623256
Study type Interventional
Source Augusta University
Contact Efrain Riveros Perez, MD
Phone 7067217361
Email eriverosperez@augusta.edu
Status Recruiting
Phase Phase 4
Start date October 28, 2019
Completion date October 31, 2023

See also
  Status Clinical Trial Phase
Completed NCT03539562 - Therapeutic Rest to Delay Admission in Early Labor: A Prospective Study on Morphine Sleep
Withdrawn NCT04662450 - Evaluation and Management of Parturients' Pain Intensity N/A
Completed NCT02885350 - Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour Phase 4
Completed NCT02550262 - Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor N/A
Completed NCT01598506 - Intrathecal Hydromorphone for Labor Analgesia Phase 2
Withdrawn NCT01636999 - Comparing Sedara to Butorphanol in Early Labor N/A
Completed NCT00987441 - Epidural Labor Analgesia and Infant Neurobehavior N/A
Completed NCT00755092 - Effect of Doula in Nulliparas and Multiparas N/A
Terminated NCT00787176 - The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes N/A
Recruiting NCT06036797 - Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia Phase 2
Completed NCT05512065 - Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women N/A
Completed NCT05327088 - Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia Phase 2
Completed NCT03103100 - Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation Phase 3
Active, not recruiting NCT02271100 - Assessment of the Use of Ultrasound for Epidural Catheter Placement and Comparison With Palpation Technique N/A
Completed NCT02926469 - Virtual Reality Analgesia in Labor: The VRAIL Pilot Study N/A
Completed NCT03712735 - Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women Phase 4
Not yet recruiting NCT05565274 - Outcome of Combined Tramadol and Paracetamol Versus Pentazocine as Labour Analgesia Among Parturients N/A
Recruiting NCT02575677 - Oxycodone in Treatment of Early Labour Pain Efficacy and Safety
Recruiting NCT01708668 - The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia N/A
Completed NCT02327559 - Prenatal Education About Reducing Labor Stress (PEARLS) N/A