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Epidural Fentanyl for 2nd Stage Labor Analgesia

Sponsor
Ohio State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03120780
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
65.2
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is being done to investigate if there is more effective pain relief during the latter stages of labor and delivery when epidural fentanyl 100mcg is administered compared to epidural fentanyl 20mcg.

Condition or Disease Intervention/Treatment Phase
  • Drug: Fentanyl 20 mcg
  • Drug: Fentanyl 100 mcg
 Phase 4

Detailed Description

The objective is to evaluate if high-dose epidural fentanyl (100 micrograms) is more effective at providing pain relief during the late first stage (>8 cm cervical dilation) and second stage of labor until the time of delivery compared to low-dose epidural fentanyl (20 micrograms). In this study, anesthetic care will be provided to a subject by an experienced anesthesia provider according to standard hospital care. If the subject has adequate pain relief from the continuous epidural infusion, then a study investigator will record the verbal pain score and document any other side effects at hourly intervals beginning at >8cm cervical dilation, but no additional epidural medications will be administered. If pain relief becomes inadequate during the late first or second stage of labor (>8cm cervical dilation) and a manual epidural bolus is required, then the subject will be randomly assigned to one of two groups (like flipping a coin): one group will receive lower dose epidural fentanyl (20 micrograms) combined with local anesthetic; and one group will receive higher-dose epidural fentanyl (100micrograms) combined with the same amount of local anesthetic. Both doses are used frequently on labor and delivery and are considered to be safe based on available evidence. If there is not sufficient pain relief from the epidural medication given, then an experienced anesthesia provider will assess if another epidural dose may be effective and this additional epidural medication will be given at the discretion of the anesthesia provider. An experienced anesthesia provider will be available at all times during the study to assess pain and provide epidural medications. All patients participating in the study will have their pain scores assessed every hour as soon as the cervical dilation is noted to be >8cm; at the time of randomization; and at 10, 20, 30 and 60 minutes after the epidural dose is administered. The presence of any side-effects such as itching, shivering, nausea, vomiting, low blood pressure, slow respiratory rate or lower extremity muscle weakness will also be collected at hourly intervals as soon as the cervical dilation is noted to be >8cm. Subject satisfaction (1-100 rating scale) with anesthetic care provided will be assessed on postpartum day # 1 during routine follow-up visit.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Subjects will be randomly assigned to one of two groups: one group will receive lower dose epidural fentanyl (20 micrograms) combined with local anesthetic; and one group will receive higher-dose epidural fentanyl (100micrograms) combined with the same amount of local anesthetic.Subjects will be randomly assigned to one of two groups: one group will receive lower dose epidural fentanyl (20 micrograms) combined with local anesthetic; and one group will receive higher-dose epidural fentanyl (100micrograms) combined with the same amount of local anesthetic.
Masking:
Single (Participant)
Masking Description:
The subject and the research personnel will be blinded to the arm to which they are randomized. Only the clinician assessing the patient and administering epidural doses will be not be blinded to the study group.
Primary Purpose:
Prevention
Official Title:
High Dose Epidural Fentanyl for Second Stage Labor Analgesia
Actual Study Start Date :
Jun 26, 2017
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Low Dose Fentanyl

Low dose epidural fentanyl combined with local anesthetic as 10mL of 0.125% bupivacaine with 20 mcg fentanyl (Fentanyl 20 mcg)

Drug: Fentanyl 20 mcg
20 mcg fentanyl in 10 mL 0.125% bupivacaine
Other Names:
  • Low Dose

    		•
    Experimental: High Dose Fentanyl

    High dose epidural fentanyl combined with local anesthetic as 10mL of 0.125% bupivacaine with 100 mcg fentanyl (Fentanyl 100 mcg)

    Drug: Fentanyl 100 mcg
    100 mcg fentanyl in 10 mL 0.125% bupivacaine
    Other Names:
  • High Dose

    		•

    Outcome Measures

    Primary Outcome Measures

    1. VRS Pain Score [30 minutes after epidural bolus]

      VRS Pain score

    Secondary Outcome Measures

    1. VRS Pain Score [At Time of Delivery]

      VRS Pain Score

    2. Mode of Delivery [At Time of Delivery]

      Mode of Delivery (cesarean, spontaneous vaginal or assisted vaginal delivery)

    3. Patient Satisfaction [During labor until post-partum day one]

      Patient Satisfaction with Labor Pain Control (1-100 rating scale; 1= not satisfied at all, 100=completely satisfied)

    4. Adverse Events [During labor until post-partum day one]

      Nausea, vomiting, shivering, pruritis, hypotension, motor block, maternal respiratory depression, neonatal outcomes

    5. Rescue Epidural Boluses [Until delivery]

      Total number of clinician administered epidural boluses during the late first (≥8cm cervical dilation) and second stages of labor

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Nulliparous women

    2. Spontaneous labor

    3. A single vertex presentation fetus at term (38-42 weeks)

    4. Effective labor epidural analgesia with continuous epidural infusion established

    5. Provide written consent to participate in the study.

    Exclusion Criteria:

    1. Multigravida women

    2. Multigestation pregnancies

    3. Patients being treated/managed for chronic pain

    4. Allergies or significant adverse reactions to local anesthetic or opioid medications

    5. Inadequate or unsatisfactory labor epidural analgesia

    6. Patients with history of spine abnormalities or spine surgery

    7. Non-English speaking

    8. Prisoners

    9. Age less than 18 years old

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Ohio State University Wexner Medical Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University

    Investigators

    • Principal Investigator: John Coffman, MD, The Ohio State University Wexner Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Blair Hayes, Assistant Professor - Clinical, Ohio State University
    ClinicalTrials.gov Identifier:
    NCT03120780
    Other Study ID Numbers:
    • 2016H0439
    First Posted:
    Apr 19, 2017
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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.:
    No
    Additional relevant MeSH terms:
    Labor Pain
    Fentanyl

    Study Results

    No Results Posted as of Mar 4, 2022