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Epidural Fentanyl for 2nd Stage Labor Analgesia

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ClinicalTrials.gov Identifier: NCT03120780
Recruitment Status : Recruiting
First Posted : April 19, 2017
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Blair Hayes, Ohio State University

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
Labor Pain 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : June 26, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: High Dose




Primary Outcome Measures :
  1. VRS Pain Score [ Time Frame: 30 minutes after epidural bolus ]
    VRS Pain score


Secondary Outcome Measures :
  1. VRS Pain Score [ Time Frame: At Time of Delivery ]
    VRS Pain Score

  2. Mode of Delivery [ Time Frame: At Time of Delivery ]
    Mode of Delivery (cesarean, spontaneous vaginal or assisted vaginal delivery)

  3. Patient Satisfaction [ Time Frame: 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 [ Time Frame: During labor until post-partum day one ]
    Nausea, vomiting, shivering, pruritis, hypotension, motor block, maternal respiratory depression, neonatal outcomes

  5. Rescue Epidural Boluses [ Time Frame: Until delivery ]
    Total number of clinician administered epidural boluses during the late first (≥8cm cervical dilation) and second stages of labor



Information from the National Library of Medicine

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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:   Must be pregnant woman to considered for study.
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03120780


Contacts
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Contact: John Coffman, MD 614-293-8487 john.coffman@osumc.edu
Contact: Juan Fiorda, MD 614-293-3559 juan.fiorda@osumc.edu

Locations
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United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: John Coffman, MD    614-293-8497    john.coffman@osumc.edu   
Contact: Juan Fiorda, MD    614-293-3559    juan.fiorda@osumc.edu   
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: John Coffman, MD The Ohio State University Wexner Medical Center
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Responsible Party: Blair Hayes, Assistant Professor - Clinical, Ohio State University
ClinicalTrials.gov Identifier: NCT03120780    
Other Study ID Numbers: 2016H0439
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD.

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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.: No
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics