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Opioid Analgesic
Epidural Fentanyl for Labor Pain
Phase 4
Recruiting
Led By John Coffman, MD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Effective labor epidural analgesia with continuous epidural infusion established
A single vertex presentation fetus at term (38-42 weeks)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until delivery
Awards & highlights
Study Summary
This trial is testing if a higher dose of epidural fentanyl provides more pain relief during labor and delivery.
Who is the study for?
This trial is for first-time mothers in spontaneous labor, with a single baby in the correct head-down position at term (38-42 weeks), who can understand and agree to the study. They should have effective pain relief from an existing epidural but no chronic pain issues, allergies to opioids or local anesthetics, spine problems, or history of spine surgery.Check my eligibility
What is being tested?
The study compares two doses of fentanyl given through an epidural during later stages of labor: a lower dose (20 mcg) versus a higher dose (100 mcg). The goal is to determine which dosage provides better pain relief during childbirth.See study design
What are the potential side effects?
Possible side effects include nausea, itching, respiratory depression (slow breathing), drowsiness, and decreased blood pressure. These are common opioid-related side effects that may vary depending on the individual's reaction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have an effective labor epidural in place.
Select...
My baby is in the head-down position and I am 38-42 weeks pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during labor until post-partum day one
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during labor until post-partum day one
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Adverse Events
Mode of Delivery
Patient Satisfaction
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: High Dose FentanylExperimental Treatment1 Intervention
High dose epidural fentanyl combined with local anesthetic as 10mL of 0.125% bupivacaine with 100 mcg fentanyl (Fentanyl 100 mcg)
Group II: Low Dose FentanylActive Control1 Intervention
Low dose epidural fentanyl combined with local anesthetic as 10mL of 0.125% bupivacaine with 20 mcg fentanyl (Fentanyl 20 mcg)
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Who is running the clinical trial?
Ohio State UniversityLead Sponsor
830 Previous Clinical Trials
505,470 Total Patients Enrolled
1 Trials studying Labor Pain
50 Patients Enrolled for Labor Pain
John Coffman, MDPrincipal InvestigatorThe Ohio State University Wexner Medical Center
1 Previous Clinical Trials
150 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an effective labor epidural in place.I have had spine surgery or have spine abnormalities.I am under 18 years old.Women who have never given birth.You are pregnant with more than one baby.My labor epidural did not work well for pain relief.I have been pregnant more than once.You went into labor on your own, without needing any help.My baby is in the head-down position and I am 38-42 weeks pregnant.I am currently being treated for chronic pain.You are allergic to local anesthetics or opioid medications.
Research Study Groups:
This trial has the following groups:- Group 1: Low Dose Fentanyl
- Group 2: High Dose Fentanyl
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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