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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will examine recent claims regarding the beneficial effect of warming epidural medications in order to hasten the onset of labor analgesia.

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.

What data supports the effectiveness of the treatment Pocket-warming of epidural medication for labor pain management?

Research shows that epidural analgesia, which involves injecting medication near the spinal cord to block pain, is a widely accepted and effective method for pain relief during labor. Techniques like the combined spinal-epidural block provide rapid pain relief with minimal side effects, suggesting that innovations like preheating the medication could potentially enhance these benefits. ^{1 2 3 4 5}

Is warmed epidural medication safe for labor pain management?

Epidural anesthesia is generally considered safe for labor pain relief, with studies showing it is effective and widely used. While there are some concerns about potential drawbacks, the association with complications like cesarean sections is not proven to be causal. ^{1 2 6 7 8}

How is the warmed epidural medication for labor pain management different from other treatments?

The warmed epidural medication for labor pain management is unique because it involves administering bupivacaine with fentanyl at a warmer temperature (37°C), which can lead to a faster onset of pain relief compared to the standard room temperature administration. ^{1 4 9 10 11}

Research Team

John Coffman, MD

Principal Investigator

Ohio State University

Eligibility Criteria

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.

Provide written consent for the study.

Intact fetal membranes or membrane rupture <6 hours previously

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

[Combined spinal-epidural block for labor analgesia. Comparative study with continuous epidural block]. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

New techniques and drugs for epidural labor analgesia. [2019]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Progress in analgesia for labor: focus on neuraxial blocks. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Epidural analgesia in labour and neonatal respiratory distress: a case-control study. [2014]

5. India pubmed.ncbi.nlm.nih.gov

Labor Epidural Analgesia: Comparison of Two Different Intermittent Bolus Regimes. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Epidural anesthesia and the progress of labor. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Association of Epidural Analgesia in Women in Labor With Neonatal and Childhood Outcomes in a Population Cohort. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Epidural analgesia in labor: an evaluation of risks and benefits. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of bupivacaine with fentanyl temperature on initiation and maintenance of labor epidural analgesia: a randomized controlled study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Knowledge About Epidural Analgesia Among Women in Al-Qassim Province of Saudi Arabia. [2023]

11. India pubmed.ncbi.nlm.nih.gov

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