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

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ClinicalTrials.gov Identifier: NCT03623256
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Efrain Riveros Perez, MD, Augusta University

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.


Condition or disease Intervention/treatment Phase
Labor Pain Obstetric Pain Drug: Spinal fentanyl Drug: Spinal bupivacaine Drug: Spinal Fentanyl and Bupivacaine Drug: Epidural fentanyl /spinal bupivacaine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 558 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Single (Participant)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Comparison of Intrathecal Versus Epidural Fentanyl: Effect of Neuraxial Route of Administration on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia
Actual Study Start Date : October 28, 2019
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Spinal Fentanyl
Spinal dose of preservative-free fentanyl 25 mcg (Volume 0.5 mL)
Drug: Spinal fentanyl
25 mcg of fentanyl (0.5 mL) will be administered by intrathecal route.
Other Name: Fentora

Active Comparator: Spinal Bupivacaine
Spinal dose of preservative-free 0.25% bupivacaine (Volume 0.5 mL)
Drug: Spinal bupivacaine
1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL) will be administered by intrathecal route.
Other Name: Marcaine

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).
Drug: 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.
Other Name: Marcaine and Fentora

Experimental: Epidural fentanyl /spinal bupivacaine
Spinal preservative-free 0.25% bupivacaine (Volume 0.5 mL) and epidural fentanyl 100 mcg (Volume 2 mL).
Drug: 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.
Other Name: Marcaine and Fentora




Primary Outcome Measures :
  1. Fetal heart rate [ Time Frame: 20 minutes (Starting from placement of labor neuraxial block) ]
    Fetal bradycardia and abnormal fetal heart rate tracing


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 20 minutes (Starting from placement of labor neuraxial block) ]
    Maternal systolic, diastolic and mean arterial pressure measured at baseline and every 5 minutes after administration of medication

  2. Dermatomal level [ Time Frame: 20 minutes (Starting from placement of labor neuraxial block) ]
    Analgesic level measured by sensitivity to temperature stimulus

  3. Maternal Pain level: visual analogue scale [ Time Frame: 20 minutes (Starting from placement of labor neuraxial block) ]
    Pain evaluated by visual analogue scale (0, no pain; 10, worst pain)

  4. Patient satisfaction level: Likert Scale [ Time Frame: 20 minutes (Starting from placement of labor neuraxial block) ]
    Satisfaction level measured by Likert Scale (5: fully satisfied, 4: satisfied, 3: neutral, 2: dissatisfied, 1: fully dissatisfied)

  5. Uterine tone [ Time Frame: 20 minutes (Starting from placement of labor neuraxial block) ]
    Measured with tocometer (In milimeters above baseline) at baseline and during 20 minutes after medication administration.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant patients in labor
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623256


Contacts
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Contact: Efrain Riveros Perez, MD 7067217361 eriverosperez@augusta.edu
Contact: Alexander R Rocuts Martinez, MD 3304074681 krocutsmartinez@augusta.edu

Locations
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United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Steffen Meiler, MD    706-721-3671    smeiler@augusta.edu   
Sponsors and Collaborators
Augusta University
Investigators
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Principal Investigator: Efrain Riveros Perez, MD Augusta University
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Responsible Party: Efrain Riveros Perez, MD, Assistant Professor Department of Anesthesiology and Perioperative Medicine, Augusta University
ClinicalTrials.gov Identifier: NCT03623256    
Other Study ID Numbers: 1238162
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The study team will decide about sharing information upon request

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Bradycardia
Labor Pain
Pain
Neurologic Manifestations
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Fentanyl
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General