Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia

NCT03623256 | Unknown Phase 4 FDA Drug

• 1 other identifier: 1238162
• Study Type: interventional
• Target: 558
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Fetal heart rate

  Fetal bradycardia and abnormal fetal heart rate tracing

  20 minutes (Starting from placement of labor neuraxial block)

Secondary Outcomes (5)

• Blood pressure

  20 minutes (Starting from placement of labor neuraxial block)

• Dermatomal level

  20 minutes (Starting from placement of labor neuraxial block)

• Maternal Pain level: visual analogue scale

  20 minutes (Starting from placement of labor neuraxial block)

• Patient satisfaction level: Likert Scale

  20 minutes (Starting from placement of labor neuraxial block)

• Uterine tone

  20 minutes (Starting from placement of labor neuraxial block)

Study Arms (4)

Spinal Fentanyl

ACTIVE COMPARATOR

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

Drug: Spinal fentanyl

Spinal Bupivacaine

ACTIVE COMPARATOR

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

Drug: Spinal bupivacaine

Spinal Fentanyl and Bupivacaine

ACTIVE COMPARATOR

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

Drug: Spinal Fentanyl and Bupivacaine

Epidural fentanyl /spinal bupivacaine

EXPERIMENTAL

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

Drug: Epidural fentanyl /spinal bupivacaine

Interventions

Spinal fentanyl DRUG

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

Also known as: Fentora

Spinal Fentanyl

Spinal bupivacaine DRUG

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

Also known as: Marcaine

Spinal Bupivacaine

Spinal Fentanyl and Bupivacaine DRUG

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.

Also known as: Marcaine and Fentora

Spinal Fentanyl and Bupivacaine

Epidural fentanyl /spinal bupivacaine DRUG

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.

Also known as: Marcaine and Fentora

Epidural fentanyl /spinal bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant patients in labor
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

MeSH Terms

Conditions

Labor Pain

Interventions

Fentanyl; Bupivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Efrain Riveros Perez, MD

  Augusta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Efrain Riveros Perez, MD

CONTACT

7067217361; eriverosperez@augusta.edu

Alexander R Rocuts Martinez, MD

CONTACT

3304074681; krocutsmartinez@augusta.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be blinded. The investigators will not be blinded because they are the same care providers. In addition, the volume of intrathecal anesthetic is different when bupivacaine plus fentanyl is used in comparison with only one medication used.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Department of Anesthesiology and Perioperative Medicine

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 9, 2018
• Study Start: October 28, 2019
• Primary Completion: October 1, 2023
• Study Completion: October 31, 2023
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

US (1)