Warmed Epidural Medication for Labor Pain Management

Overseen By John Coffman, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Local anesthetics, Opioids

Disqualifiers: Chronic pain, Spine abnormalities, Infection, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Duration of labor and delivery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether warming epidural medications can relieve labor pain more quickly. Participants will receive either warmed epidural medication or medication at room temperature to determine which is more effective. The trial includes women who are full-term with a single baby, whose water broke within the last six hours, and who have requested an epidural during labor. Interested individuals must not be undergoing chronic pain treatment, have allergies to related medications, or have certain spine issues.

As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance labor pain management for future mothers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are being treated for chronic pain, you would not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that warming epidural medications before administration is safe. One study found that warming the medication caused no harm, indicating patients tolerate it well. Another study noted that heating the epidural medication to body temperature (37°C) can make it work faster. These findings suggest that using warmed epidural medications is both effective and safe for those considering this option during labor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of pocket-warmed epidural medication for labor pain management because it introduces a simple yet potentially impactful modification to the standard procedure. Unlike traditional epidural medications that are administered at room temperature, the pocket-warming technique involves warming the medication before administration. This could enhance the comfort and effectiveness of pain relief more quickly by possibly improving the medication's absorption rate. The trial aims to determine if this small change can make a significant difference in the labor experience for expectant mothers.

What evidence suggests that pocket-warming epidural medication could be effective for labor pain management?

This trial will compare the effects of pocket-warmed epidural medication with room-temperature epidural medication for labor pain management. Research has shown that warming epidural medication before use can speed up pain relief during labor. One study found that pain relief began in about 9.2 minutes with warmed medication, compared to 16 minutes with room-temperature medication. This suggests that warming the medication can make it work faster. Another study found that warming the medication to body temperature (37°C) improves its effectiveness. Thus, using warmed epidural medication might help manage labor pain more quickly. ^{1 2 3 4 6}

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 women at term (38-42 weeks) with a single baby in head-down position, who want an epidural for labor pain relief. They must understand English and give written consent. It's not for those under 18, with spine issues, fever, infection signs, or allergies to pain meds.

Inclusion Criteria

I am pregnant with one baby in the head-down position, due between 38-42 weeks.

Intact fetal membranes or membrane rupture <6 hours previously

Provide written consent for the study.

Exclusion Criteria

I cannot have an epidural during labor due to health reasons.

I have had spine surgery or spine problems in the past.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either pocket-warmed or room-temperature epidural medication during labor

Duration of labor and delivery

Continuous monitoring during labor

Follow-up

Participants assess labor analgesia satisfaction and vital signs are monitored

First hour post-epidural administration

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Pocket-warming
• Standard of Care Labor Epidural

Trial Overview The study is testing if warming up the medication used in epidurals can speed up pain relief during labor. Women will either get their epidural medication warmed ('Pocket-warming') or receive the standard care without warming.

How Is the Trial Designed?

Group I: Pocket-warmed epidural medication Experimental Treatment 1 Intervention

This arm will consist of pocket-warmed epidural medications to be administered per standard protocol to patients randomized to this group; this group is the pocket-warming group.

Group II: Room-temperature epidural medication Active Control 1 Intervention

This arm will consist of room-temperature epidural medications to be administered per standard protocol to patients randomized to this group. This group has no experimental intervention; standard of care labor epidural.

Standard of Care Labor Epidural is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Epidural Block for:

• Pain relief during labor and delivery
• Cesarean sections

Approved in European Union as Epidural Anaesthesia for:

• Pain relief during labor and delivery
• Cesarean sections
• Postpartum care

Approved in Canada as Epidural Block for:

• Pain relief during labor and delivery
• Cesarean sections

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

The combined spinal-epidural block provided faster pain relief (4.5 minutes) and lower pain scores during labor compared to the continuous epidural block (11.6 minutes), making it a more effective option for labor analgesia.

Patients receiving the combined block had a higher rate of spontaneous deliveries (80%) and fewer cesarean sections (4 cases) compared to those with the continuous block (50% spontaneous deliveries and 8 cesarean sections), indicating better overall outcomes for the combined technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Combined spinal-epidural block for labor analgesia. Comparative study with continuous epidural block]. Braga, AFA., Carvalho, VH., Braga, FSDS., et al.[2022]

Ropivacaine and levobupivacaine are new medications that enhance epidural labor analgesia, providing effective pain relief during labor.

The article discusses important clinical practices such as patient-controlled epidural analgesia and ambulatory techniques, which improve patient comfort and mobility during labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New techniques and drugs for epidural labor analgesia. Drysdale, SM., Muir, H.[2019]

A study involving 206 cases of neonates with respiratory distress and 206 matched controls found that exposure to epidural analgesia during labor significantly increased the likelihood of respiratory distress in late-preterm and term infants, with an adjusted odds ratio of 1.75.

The results were consistent across both term and late-preterm infants, indicating that maternal use of epidural analgesia may pose a risk for respiratory complications in newborns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural analgesia in labour and neonatal respiratory distress: a case-control study. Kumar, M., Chandra, S., Ijaz, Z., et al.[2014]

In a study of 50 parturients, a larger epidural bolus of 20 mL of 0.1% ropivacaine with 40 μg fentanyl provided significantly faster onset of analgesia (88% within 7 minutes) and longer duration of pain relief (166.8 minutes) compared to a smaller bolus of 15 mL with 15 μg fentanyl.

Both bolus regimens resulted in effective labor analgesia without motor blockade, indicating that both options are safe and effective for pain management during labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Labor Epidural Analgesia: Comparison of Two Different Intermittent Bolus Regimes. Puthenveettil, N., Mohan, A., Rajan, S., et al.[2022]

In a study of 54 laboring women, administering warmed bupivacaine (37°C) with fentanyl resulted in a significantly faster onset of analgesia, taking an average of 9.2 minutes compared to 16.0 minutes with room temperature bupivacaine (20°C).

While the warmed bupivacaine provided better initial pain relief in the first 15 minutes, there were no differences in ongoing analgesia or side effects between the two temperature groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of bupivacaine with fentanyl temperature on initiation and maintenance of labor epidural analgesia: a randomized controlled study. Sviggum, HP., Yacoubian, S., Liu, X., et al.[2022]

A survey of 483 women in Al-Qassim Province, Saudi Arabia, revealed that those with previous pregnancies had a better understanding of epidural analgesia, recognizing it as an effective pain relief method during labor.

Despite some awareness, the study indicates that knowledge about epidural analgesia is limited among women, highlighting the need for healthcare providers to improve education and awareness regarding this pain management technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge About Epidural Analgesia Among Women in Al-Qassim Province of Saudi Arabia. Geddawy, M., Alkraydees, SS., Almadhi, MM., et al.[2023]

In a pilot study involving 30 first-time mothers, the combination of 0.2% ropivacaine and 25 mcg fentanyl provided effective pain relief during labor, significantly reducing pain scores after administration.

While the analgesia was effective, some participants experienced mild side effects like tingling and heaviness in the lower limbs, suggesting that lower concentrations of ropivacaine may be more suitable for maintaining labor analgesia without compromising mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

0.2% ropivacaine with fentanyl in the management of labor analgesia: A case study of 30 parturients. Karhade, SS., Sardesai, SP.[2022]

Epidural block is recognized as the most effective and safe method for pain relief during labor, and its popularity is increasing among expectant mothers.

Recent evidence suggests that previous concerns linking epidural block to complications like dystocia and cesarean sections are unfounded, supporting its continued use in labor without the stigma of associated risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural anesthesia and the progress of labor. Cheek, TG., McGonigal, ET.[2019]

Neuraxial analgesia is recognized as the most effective and least depressant method for pain relief during labor, providing high-quality pain management with minimal side effects for both mothers and babies.

Advancements such as the combined spinal epidural technique and patient-controlled epidural analgesia have enhanced flexibility and comfort for laboring women, allowing for rapid pain relief while maintaining mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress in analgesia for labor: focus on neuraxial blocks. Ranasinghe, JS., Birnbach, DJ.[2023]

A study of 435,281 singleton live births in Scotland found that labor epidural analgesia is not independently linked to negative neonatal or childhood development outcomes, suggesting it is a safe option for pain management during labor.

While epidural analgesia was initially associated with increased risks of neonatal resuscitation and admission to the neonatal unit, these risks were likely influenced by the mode of delivery, indicating that the method of birth plays a significant role in these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Epidural Analgesia in Women in Labor With Neonatal and Childhood Outcomes in a Population Cohort. Kearns, RJ., Shaw, M., Gromski, PS., et al.[2023]

Epidural analgesia is a safe and effective pain relief method during labor, but it can lead to longer labor durations and increased rates of operative interventions like cesarean sections, particularly in first-time mothers.

Common complications such as hypotension and headaches are usually manageable, but there are potential risks like maternal fever and chronic back pain that require further investigation, highlighting the need for informed counseling for expectant mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural analgesia in labor: an evaluation of risks and benefits. Thorp, JA., Breedlove, G.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02912078

NCT02912078 | Pocket Warming of Epidural Medication Studies have shown that warmed epidural medication resulted in a mean analgesic onset of 9.2 minutes as compared to a mean onset of 16 minutes for the same ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11373790/

Pocket warming of bupivacaine with fentanyl to shorten ... Warming the initial dose of epidural medications to 37°C prior to administration has been studied as well, and it was shown to shorten the onset of action of ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0309515

Pocket warming of bupivacaine with fentanyl to shorten onset ... It has been documented that prewarming epidural medications to body temperature (37°C) prior to administration increases medication efficacy.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5896064/

Effectiveness and safety of moderate-intensity aerobic water ... Epidural analgesia during labor can provide effective pain relief, but can also lead to adverse effects. The practice of moderate exercise ...

5. researchgate.net researchgate.net/publication/383754659_Pocket_warming_of_bupivacaine_with_fentanyl_to_shorten_onset_of_labor_epidural_analgesia_A_double-blind_randomized_controlled_clinical_trial?_tp=eyJjb250ZXh0Ijp7InBhZ2UiOiJzY2llbnRpZmljQ29udHJpYnV0aW9ucyIsInByZXZpb3VzUGFnZSI6bnVsbCwic3ViUGFnZSI6bnVsbH19

Pocket warming of bupivacaine with fentanyl to shorten ... Pocket warming of bupivacaine with fentanyl to shorten onset of labor epidural analgesia: A double-blind randomized controlled clinical trial.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39231197/

Pocket warming of bupivacaine with fentanyl to shorten ... It has been documented that prewarming epidural medications to body temperature (37°C) prior to administration increases medication efficacy.