Epidural Fentanyl for Labor Pain

Overseen By John Coffman, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Ohio State University

Must be taking: Epidural analgesia

Must not be taking: Opioids, local anesthetics

Disqualifiers: Chronic pain, Spine issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: During labor until delivery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a higher dose of fentanyl, a pain relief medication, provides better pain management during the later stages of labor compared to a lower dose. The study tests two different doses of fentanyl administered through an epidural, a type of anesthesia often used during childbirth. Ideal candidates for this trial are first-time mothers in natural labor with one baby, who have already begun effective pain management through an epidural. Participants should not have a history of back issues or allergies to pain medications. As a Phase 4 trial, this research seeks to understand how an already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for fentanyl?

Research has shown that fentanyl is generally safe for managing labor pain. One study found that both intravenous (through a vein) and subcutaneous (under the skin) fentanyl effectively reduced pain during labor in low-risk pregnancies without major safety issues. Another study examined the use of epidural fentanyl combined with bupivacaine (a numbing medicine) and found it safe for pain relief during labor. These studies support that fentanyl, whether administered in different ways or combined with other medications, is well-tolerated for managing pain during childbirth. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using epidural fentanyl for labor pain because it offers a potentially more tailored approach to pain management. Unlike standard epidural options, which might use higher doses of local anesthetics alone, this trial explores combining bupivacaine with varying doses of fentanyl. The low-dose arm uses 20 mcg of fentanyl, providing a gentler option that might minimize side effects, while the high-dose arm uses 100 mcg, aiming for more robust pain relief. This variability allows for personalized pain management during labor, potentially improving comfort and satisfaction for mothers.

What evidence suggests that this trial's treatments could be effective for labor pain?

This trial will compare low-dose and high-dose epidural fentanyl for managing labor pain. Research has shown that epidural fentanyl effectively manages labor pain. One study found that combining fentanyl with bupivacaine reduces labor pain without causing significant muscle weakness. This method provides good pain relief during childbirth. Another study confirmed that fentanyl, whether applied through the skin or given directly into a vein, safely reduces pain during labor. Overall, fentanyl is well-regarded for its effectiveness in easing labor pain. ^{1 2 3 4 5}

Who Is on the Research Team?

John Coffman, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I have had spine surgery or have spine abnormalities.

I am under 18 years old.

Non-English speaking

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: High Dose Fentanyl Experimental Treatment 1 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 Fentanyl Active Control 1 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

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

In a study of 40 women receiving epidural analgesia during labor, a dose of 0.1 mg fentanyl provided effective pain relief within 6 to 15 minutes, lasting for an average of 130 minutes without impairing mobility.

The use of fentanyl did not cause any significant side effects such as nausea or circulatory disturbances, and all participants reported a positive experience with this method of pain relief during delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Peridural analgesia with fentanyl--an alternative to control of labor pain]. Francke, A., Frahm, R.[2013]

In a study of 80 healthy women in active labor, both patient-controlled and nurse-administered fentanyl provided similar levels of pain relief, indicating that the method of administration does not significantly affect analgesic efficacy.

There were no significant side effects such as maternal oversedation or vomiting, and neonatal outcomes were comparable between the two groups, suggesting that fentanyl is a safe option for pain management during labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of patient-controlled and nurse-administered analgesia using intravenous fentanyl during labor. Rayburn, WF., Smith, CV., Leuschen, MP., et al.[2013]

In a study involving 46 laboring women, epidural fentanyl (100 microg) provided pain relief comparable to epidural sufentanil (20 microg) during early labor, indicating both are effective options for analgesia.

The duration of analgesia was similar for both medications, with sufentanil lasting an average of 138 minutes and fentanyl 124 minutes, and side effects were also comparable, suggesting both options are safe for use in this setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of epidural fentanyl versus epidural sufentanil for analgesia in ambulatory patients in early labor. Connelly, NR., Parker, RK., Vallurupalli, V., et al.[2019]

Both fentanyl and sufentanil, when combined with low concentrations of bupivacaine, provided equivalent labor analgesia and maternal satisfaction in a study of 50 laboring women.

Sufentanil was found to be 10 times more potent than fentanyl for analgesia, but both combinations did not significantly differ in terms of pain scores, cesarean delivery rates, or neonatal Apgar scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of efficacy of bupivacaine and fentanyl with bupivacaine and sufentanil for epidural labor analgesia. Kalra, S., Saraswat, N., Agnihotri, GS.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Oral transmucosal fentanyl citrate is an effective treatment for breakthrough pain in cancer patients due to its rapid onset and short duration, making it suitable for managing sudden pain flares in patients already on opioid therapy.

The review discusses the drug's synthesis, pharmacological properties, and clinical efficacy, highlighting its role in improving pain management for cancer patients experiencing transitory pain episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral transmucosal fentanyl citrate for the treatment of breakthrough pain in cancer patients: an overview of its pharmacological and clinical characteristics. Mystakidou, K., Katsouda, E., Parpa, E., et al.[2022]

Epidural fentanyl significantly reduces the need for bupivacaine during labor, indicating its effectiveness in providing pain relief through a spinal mechanism.

In a study of 54 laboring patients, epidural fentanyl was shown to produce analgesia primarily through spinal action, while intravenous fentanyl did not have the same effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural fentanyl produces labor analgesia by a spinal mechanism. D'Angelo, R., Gerancher, JC., Eisenach, JC., et al.[2019]

Fentanyl sublingual tablets provide rapid pain relief for opioid-tolerant cancer patients, significantly reducing pain intensity compared to placebo within 15 minutes after administration, as shown in two randomized clinical trials.

The treatment was well tolerated, with most side effects being mild to moderate, and nearly half of the patients reported being satisfied or very satisfied with their pain management using fentanyl sublingual.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fentanyl sublingual: in breakthrough pain in opioid-tolerant adults with cancer. Chwieduk, CM., McKeage, K.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

μ-opioid receptor genetic polymorphisms and duration of epidural fentanyl analgesia during early labor. Zgheib, NK., Aouad, MT., Taha, SK., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural anesthesia for labor in an ambulatory patient. Breen, TW., Shapiro, T., Glass, B., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2589933324000363

Subcutaneous vs intravenous fentanyl for labor pain ... Both intravenously and subcutaneously administered fentanyl were safe and significantly reduced pain from baseline to delivery among low-risk pregnancies.

2. journals.lww.com journals.lww.com/md-journal/fulltext/2015/06020/epidural_analgesia_with_bupivacaine_and_fentanyl.8.aspx

Epidural Analgesia With Bupivacaine and Fentanyl Versus... Analgesia with ropivacaine in combination with fentanyl at 0.1%:0.0002% ratio for labor pain relief is associated with lower incidence of motor blocks.

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK69374/

Parenteral opioids for labor pain relief: a systematic review Women in the intravenous group received significantly more pethidine and reported significantly lower labour pain than the intramuscular group in this small ...

4. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-022-05169-x

Fentanyl for labour pain management: a scoping review The most common reported neonatal outcomes were foetal heart rate (33 records, 64.7%) and Apgar score (32 records, 62.7%). Conclusion. There is ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00691795

Epidural Fentanyl-bupivacaine Versus Clonidine- ... This study is designed to compare the efficacy of two treatments for controlling late first stage breakthrough pain during labor with an ...