65 Participants Needed

Epidural Fentanyl for Labor Pain

JF
JC
Overseen ByJohn Coffman, MD
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: Ohio State University
Must be taking: Epidural analgesia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 5 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but if you are being treated for chronic pain, you cannot participate.

What data supports the effectiveness of the drug fentanyl for labor pain relief?

Research shows that epidural fentanyl is effective in providing pain relief during labor, with studies indicating that it works primarily through a spinal mechanism. Additionally, a study found that 90.6% of women receiving epidural fentanyl experienced rapid and adequate pain relief.12345

Is epidural fentanyl safe for labor pain management?

Epidural fentanyl is commonly used for labor pain relief and has been shown to be helpful without causing significant side effects like oversedation or vomiting. Studies indicate that it is generally well-tolerated, with no major safety concerns reported for mothers or newborns.12678

How does the drug fentanyl differ from other treatments for labor pain?

Epidural fentanyl is unique because it provides pain relief during labor by acting directly on the spinal cord, allowing for effective pain management without impairing movement, so women can still walk around. This is different from other treatments that might limit mobility or require higher doses of local anesthetics.134910

What is the purpose of this trial?

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.

Research Team

JC

John Coffman, MD

Principal Investigator

Ohio State University

Eligibility Criteria

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.

Inclusion Criteria

I have an effective labor epidural in place.
Women who have never given birth.
You went into labor on your own, without needing any help.
See 2 more

Exclusion Criteria

I have had spine surgery or have spine abnormalities.
I am under 18 years old.
Non-English speaking
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either low-dose or high-dose epidural fentanyl during the late first and second stages of labor

During labor until delivery
Continuous monitoring during labor

Follow-up

Participants are monitored for adverse events and satisfaction with pain control until postpartum day one

1 day
1 visit (in-person) on postpartum day #1

Treatment Details

Interventions

  • Fentanyl
Trial Overview 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.
Participant Groups
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)

Fentanyl is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Fentanyl for:
  • Pain management
  • Anesthesia
🇪🇺
Approved in European Union as Fentanyl for:
  • Severe pain
  • Breakthrough pain in cancer patients
🇨🇦
Approved in Canada as Fentanyl for:
  • Pain relief
  • Neuropathic pain
🇯🇵
Approved in Japan as Fentanyl for:
  • Cancer pain
  • Postoperative pain

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials
891
Recruited
2,659,000+

Findings from Research

In a study of 220 nulliparous women receiving epidural fentanyl for early labor analgesia, genetic variations in the OPRM1 gene did not significantly affect the duration of analgesia, with an average of 161 minutes for wild type and 143 minutes for variant allele carriers.
The study found no significant differences in pain scores, side effects, or patient satisfaction related to these genetic variations, suggesting that OPRM1 SNVs may not influence the effectiveness of epidural fentanyl in this context.
μ-opioid receptor genetic polymorphisms and duration of epidural fentanyl analgesia during early labor.Zgheib, NK., Aouad, MT., Taha, SK., et al.[2019]
Sufentanil significantly extends the duration of spinal analgesia by about 25.4 minutes compared to fentanyl, without clinically meaningful differences in pain relief after intrathecal injection, based on a meta-analysis of 12 trials involving 881 patients.
Sufentanil may be safer for infants, as evidenced by higher Apgar scores at 5 minutes after delivery compared to fentanyl, while both drugs showed similar risks for respiratory depression and side effects like pruritus, nausea, and vomiting.
Sufentanil versus fentanyl for pain relief in labor involving combined spinal-epidural analgesia: a systematic review and meta-analysis of randomized controlled trials.Zhi, M., Diao, Y., Liu, S., et al.[2020]
Both epidural analgesic regimens (fentanyl and ultra low-dose bupivacaine) provided rapid and effective pain relief during labor, with similar rates of adequate analgesia (around 90%) in both groups.
The ultra low-dose bupivacaine regimen allowed for longer-lasting pain relief and a higher percentage of women delivering without needing additional anesthetics, but it also resulted in more cases of hip flexion weakness that affected ambulation compared to the fentanyl group.
Epidural anesthesia for labor in an ambulatory patient.Breen, TW., Shapiro, T., Glass, B., et al.[2022]

References

μ-opioid receptor genetic polymorphisms and duration of epidural fentanyl analgesia during early labor. [2019]
Sufentanil versus fentanyl for pain relief in labor involving combined spinal-epidural analgesia: a systematic review and meta-analysis of randomized controlled trials. [2020]
Epidural anesthesia for labor in an ambulatory patient. [2022]
Epidural fentanyl produces labor analgesia by a spinal mechanism. [2019]
Comparison of efficacy of bupivacaine and fentanyl with bupivacaine and sufentanil for epidural labor analgesia. [2021]
Oral transmucosal fentanyl citrate for the treatment of breakthrough pain in cancer patients: an overview of its pharmacological and clinical characteristics. [2022]
Comparison of patient-controlled and nurse-administered analgesia using intravenous fentanyl during labor. [2013]
Fentanyl sublingual: in breakthrough pain in opioid-tolerant adults with cancer. [2021]
Comparison of epidural fentanyl versus epidural sufentanil for analgesia in ambulatory patients in early labor. [2019]
[Peridural analgesia with fentanyl--an alternative to control of labor pain]. [2013]
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