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

Labor Pain Clinical Trial

Official title:

Comparison of Intrathecal Versus Epidural Fentanyl: Effect of Neuraxial Route of Administration on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03623256
• Other study ID #: 1238162
• Status: Recruiting
• Phase: Phase 4
• Start date: October 28, 2019
• Est. completion date: October 31, 2023

Study information

• Verified date: July 2021
• Source: Augusta University
• Contact: Efrain Riveros Perez, MD
• Phone: 7067217361
• Email: eriverosperez[@]augusta.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 558
• Est. completion date: October 31, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bradycardia
• Labor Pain
• Obstetric Pain

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal heart rate	Fetal bradycardia and abnormal fetal heart rate tracing	20 minutes (Starting from placement of labor neuraxial block)
Secondary	Blood pressure	Maternal systolic, diastolic and mean arterial pressure measured at baseline and every 5 minutes after administration of medication	20 minutes (Starting from placement of labor neuraxial block)
Secondary	Dermatomal level	Analgesic level measured by sensitivity to temperature stimulus	20 minutes (Starting from placement of labor neuraxial block)
Secondary	Maternal Pain level: visual analogue scale	Pain evaluated by visual analogue scale (0, no pain; 10, worst pain)	20 minutes (Starting from placement of labor neuraxial block)
Secondary	Patient satisfaction level: Likert Scale	Satisfaction level measured by Likert Scale (5: fully satisfied, 4: satisfied, 3: neutral, 2: dissatisfied, 1: fully dissatisfied)	20 minutes (Starting from placement of labor neuraxial block)
Secondary	Uterine tone	Measured with tocometer (In milimeters above baseline) at baseline and during 20 minutes after medication administration.	20 minutes (Starting from placement of labor neuraxial block)