Recruiting

Fentanyl vs. Bupivacaine

Sponsor:

Augusta University

Code:

NCT03623256

Conditions

Labor Pain

Obstetric Pain

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Spinal fentanyl

Spinal bupivacaine

Spinal Fentanyl and Bupivacaine

Epidural fentanyl /spinal bupivacaine

Study Details

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.

Conditions

Labor Pain

Obstetric Pain

Study ID

NCT03623256

Start date

Oct 28, 2019

Status verified date

Jul, 2021

Completion date

Oct 31, 2023

Anticipated

Primary completion date

Oct 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

558 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Spinal Fentanyl

Spinal dose of preservative-free fentanyl 25 mcg (Volume 0.5 mL)

active comparator: Spinal Bupivacaine

Spinal dose of preservative-free 0.25% bupivacaine (Volume 0.5 mL)

active comparator: Spinal Fentanyl and Bupivacaine

Spinal combination of preservative-free 0.25% bupivacaine (0.5 mL) and fentanyl 25 mcg (0.5 mL). (Total Volume 1 mL).

experimental: Epidural fentanyl /spinal bupivacaine

Spinal preservative-free 0.25% bupivacaine (Volume 0.5 mL) and epidural fentanyl 100 mcg (Volume 2 mL).

Interventions

Spinal fentanyl

25 mcg of fentanyl (0.5 mL) will be administered by intrathecal route.

Spinal bupivacaine

1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL) will be administered by intrathecal route.

Spinal Fentanyl and Bupivacaine

1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL), and 25 mcg of fentanyl (0.5 mL) will be administered by intrathecal route.

Epidural fentanyl /spinal bupivacaine

1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL) will be administered by intrathecal route, and 100 mcg of fentanyl (2 mL) will be administered by epidural route.

Primary outcome measure

  • Fetal heart rate [ Time Frame: 20 minutes (Starting from placement of labor neuraxial block) ]

Central Contacts and Locations

Central contacts

Efrain Riveros Perez, MD

7067217361eriverosperez@augusta.edu

Alexander R Rocuts Martinez, MD

3304074681krocutsmartinez@augusta.edu

Locations

Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Steffen Meiler, MD

706-721-3671smeiler@augusta.edu

More Information

Sponsor

Augusta University

Last update posted

Jul 22, 2021

Last verified

Jul, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2021-07-22.