Bupivacaine for Labor Pain

Overseen By Ayumi Maeda, MD

Age: Any Age

Sex: Female

Trial Phase: Phase 4

Sponsor: Brigham and Women's Hospital

Must not be taking: Antiplatelet meds

Disqualifiers: Preeclampsia, Gestational diabetes, 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

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the amount of bupivacaine, a pain relief medication, needed to help women in labor feel comfortable when administered through an epidural, a common pain relief method. The trial aims to determine the right dose to relieve pain in 90% of women by comparing two techniques: one involving a small puncture and the other a standard method. Women expecting a single baby at full term who want an epidural for labor pain, especially if experiencing significant pain, might be suitable candidates. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand how it can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on antiplatelet medications, you may not be eligible to participate.

What is the safety track record for bupivacaine?

Research has shown that bupivacaine is generally safe for pain relief during labor. In low doses, it causes few side effects. The DPE (dural puncture epidural) method works particularly well, providing faster and more effective pain relief than the traditional EPL (epidural) method.

With the traditional EPL method, bupivacaine also offers good pain relief and is considered safe for both mothers and babies. However, some studies suggest it might lead to longer labor or a higher chance of needing a C-section.

Both methods using bupivacaine are well-tolerated and provide significant pain relief with a good safety record. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it aims to find out if the dural puncture epidural (DPE) technique offers better pain relief during labor compared to the traditional epidural technique. Both methods use bupivacaine, a common anesthetic, but the DPE technique involves a small puncture in the dura, potentially allowing for faster onset of pain relief and better overall management of labor pain. By comparing these two techniques, researchers hope to refine pain management during labor, potentially leading to more effective and efficient epidural options for expectant mothers.

What is the effectiveness track record for bupivacaine in managing labor pain?

Studies have shown that bupivacaine effectively relieves labor pain. In this trial, participants will receive bupivacaine through one of two techniques. Research indicates that the DPE technique, one of the methods being tested, can reduce the amount of medication needed for pain relief by 35% and provides faster and more effective pain relief compared to traditional methods. Meanwhile, many consider the EPL technique, the other method under study, the best option for managing labor pain, as many women choose it for its effective pain relief during labor. Both techniques effectively manage labor pain. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for women in labor with a pain rating of at least 5 out of 10, who are between 37-42 weeks pregnant with one baby positioned head down. They should be less than or equal to 5 cm dilated and want an epidural for pain relief. Women with major health problems can't join.

Inclusion Criteria

I rate my pain as 5 or more on a scale of 0 to 10.

Pregnant individuals without major health issues.

I am pregnant with one baby, due between 37-42 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive bupivacaine doses via either DPE or EPL technique, adjusted using a biased coin up-down allocation method

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine

Trial Overview

The study aims to find the right dose of Bupivacaine needed after a Lidocaine test dose for effective pain relief in labor using two techniques: DPE (Dural Puncture Epidural) and EPL (Epidural Labor Analgesia). A special method called biased coin up-down allocation will help estimate this optimal dose.

How Is the Trial Designed?

Group I: DPE Group Active Control 1 Intervention

Subjects will receive an epidural catheter via a dural puncture epidural technique.

Group II: EPL Group Active Control 1 Intervention

Subjects will receive an epidural catheter via a traditional epidural technique.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Published Research Related to This Trial

In a study involving 40 parturients, both epidural bupivacaine and ropivacaine combined with fentanyl provided similar levels of pain relief during labor, with no significant differences in side effects or neonatal outcomes.

Neither bupivacaine nor ropivacaine at the tested low concentrations ensured adequate analgesia during the second stage of labor, suggesting a need for further research into alternative methods or dosages for improved comfort during delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of maternal and neonatal outcomes with epidural bupivacaine plus fentanyl and ropivacaine plus fentanyl for labor analgesia. Bolukbasi, D., Sener, EB., Sarihasan, B., et al.[2018]

In a study of 60 women in labor, both ropivacaine and bupivacaine at a low concentration (0.1%) provided similar levels of analgesia, hemodynamic stability, and neonatal outcomes, indicating their equivalence as pain relief options during labor.

Ropivacaine showed a trend towards fewer motor block incidents compared to bupivacaine, with none of the women in the ropivacaine group experiencing motor block, suggesting it may be a safer option for maintaining mobility during labor, although this difference was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double blind comparison of combination of 0.1% ropivacaine and fentanyl to combination of 0.1% bupivacaine and fentanyl for extradural analgesia in labour. Bawdane, KD., Magar, JS., Tendolkar, BA.[2020]

In a study involving 40 pregnant rats, both bupivacaine and levobupivacaine were found to reduce uterine contraction frequencies during labor, but there was no significant difference in effectiveness between the two anesthetics.

Levobupivacaine resulted in less muscle relaxation compared to bupivacaine, suggesting it may be a more suitable option for labor analgesia while maintaining uterine contractility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo comparison of the effects of bupivacaine and levobupivacaine on the pregnant rat myometrium using electrohysterogram. Kaynak, G., Iskender, A., Albayrak, M., et al.[2018]

In a study involving 51 laboring patients, both 0.125% ropivacaine and 0.125% bupivacaine provided effective pain relief during labor with no significant differences in pain scores, anesthetic use, or side effects.

The results suggest that at the tested concentration, ropivacaine and bupivacaine are clinically indistinguishable for patient-controlled epidural analgesia, making either option a viable choice for labor analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

0.125% ropivacaine is similar to 0.125% bupivacaine for labor analgesia using patient-controlled epidural infusion. Owen, MD., D'Angelo, R., Gerancher, JC., et al.[2022]

In a study involving 70 patients, continuous administration of epidural bupivacaine throughout labor did not significantly impact the rates of instrument deliveries or the Apgar scores of newborns.

The findings suggest that using bupivacaine continuously during labor does not alter the overall outcomes of labor compared to stopping the medication at 8 cm of cervical dilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of second-stage 0.25% epidural bupivacaine on the outcome of labor. Luxman, D., Wolman, I., Niv, D., et al.[2018]

In a study involving 102 first-time mothers, all three epidural infusions (levobupivacaine, bupivacaine, and ropivacaine) provided effective pain relief during labor, keeping pain scores below 40 on a visual analogue scale.

However, those receiving levobupivacaine experienced higher pain scores compared to the other two groups, and bupivacaine caused a greater motor block than levobupivacaine, indicating that while all options are effective, they differ in pain control and motor function effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized comparison of levobupivacaine, bupivacaine and ropivacaine with fentanyl, for labor analgesia. Atiénzar, MC., Palanca, JM., Torres, F., et al.[2018]

Epidural ropivacaine combined with fentanyl for labor analgesia did not significantly affect the overall duration of labor stages, but it did prolong the second stage of labor while shortening the active stage duration.

This combination of analgesia was associated with a higher rate of spontaneous labor and assisted vaginal deliveries, and it may reduce the need for cesarean sections, indicating its potential efficacy in improving labor outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Influence of epidural ropivacaine in combination with fentanyl for labor analgesia on the clinical outcome of labor]. Li, Q., Li, CX., Liu, Y., et al.[2018]

In a study involving 60 nulliparous women during labor, both ropivacaine and bupivacaine provided similar levels of pain relief and motor block, indicating their equivalent efficacy for epidural analgesia.

Neither anesthetic caused significant motor blockade, with 96.66% of ropivacaine patients and 93.33% of bupivacaine patients experiencing minimal motor impairment, suggesting both are safe options for labor analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of ropivacaine and bupivacaine for epidural analgesia during labor]. Sánchez-Conde, P., Nicolás, J., Rodríguez, J., et al.[2018]

In a study of 100 women in active labor, both ropivacaine and bupivacaine provided equivalent pain relief, with similar onset times and durations of analgesia, ensuring high maternal satisfaction.

No significant differences in obstetric or neonatal outcomes were observed between the two groups, indicating that both medications are safe options for labor analgesia without compromising the health of the mother or baby.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of bupivacaine and ropivacaine in combination with fentanyl used for walking epidural anesthesia in labor. Gündüz, Ş., Eriş Yalçın, S., Karakoç, G., et al.[2022]

In a study involving 128 women, ropivacaine at a concentration of 2 mg/mL effectively managed labor pain with minimal motor block across various infusion rates (4, 6, 8, and 10 mL/hour).

The 6 mL/hour infusion rate was identified as potentially the most effective balance for pain relief and minimal motor block, while the 4 mL/hour rate resulted in less motor block despite requiring more top-up injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative evaluation of four different infusion rates of ropivacaine (2 mg/mL) for epidural labor analgesia. Cascio, MG., Gaiser, RR., Camann, WR., et al.[2019]

A single injection of intrathecal morphine and bupivacaine provided rapid pain relief for labor, with an average onset time of 2.6 minutes and effective analgesia lasting between 4 to 12 hours, allowing 93% of women not to request additional pain relief.

While the treatment group experienced longer labor durations and some mild side effects like pruritus and nausea, there were no major complications such as respiratory depression or post-spinal headaches, making this combination a safe alternative to epidural analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of intrathecal coadministration of morphine and bupivacaine for labor analgesia. Wu, JL., Hsu, MS., Hsu, TC., et al.[2015]

In a study of 4,493 women receiving labor epidural analgesia, lower concentrations of bupivacaine (0.04% and 0.0625%) resulted in fewer side effects like hypotension, but led to more instances of breakthrough pain requiring additional interventions.

Higher concentrations of bupivacaine (0.125%) were associated with less breakthrough pain but resulted in more side effects, indicating a trade-off between pain control and side effects when choosing bupivacaine concentrations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An analysis of the need for anesthetic interventions with differing concentrations of labor epidural bupivacaine: an observational study. Hess, PE., Pratt, SD., Oriol, NE.[2013]

In a study involving 450 first-time mothers, lower concentrations (0.05%) of bupivacaine, ropivacaine, and levobupivacaine provided similar levels of effective analgesia and motor block during labor, indicating that the type of anesthetic may not significantly impact outcomes.

The research found that analgesic efficacy is more dependent on the concentration of the anesthetic used rather than the specific type, as higher concentrations (≥0.1%) resulted in better pain relief compared to the lowest concentration (0.05%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of bupivacaine, ropivacaine and levobupivacaine with sufentanil for patient-controlled epidural analgesia during labor: a randomized clinical trial. Wang, LZ., Chang, XY., Liu, X., et al.[2018]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37824436/

Labor Analgesia Initiation With Dural Puncture Epidural ...

We sought to determine the effective dose of bupivacaine to achieve initial (first 30 minutes) labor analgesia in 90% of patients (ED90) with the DPE and EPL ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7179732/

Labor Analgesia Onset With Dural Puncture Epidural ...

Our data also indicate that a less concentrated local anesthetic (bupivacaine 0.125%) may be effective for epidural catheter dosing following DPE without ...

3.

bjanaesthesia.org

bjanaesthesia.org/article/S0007-0912(25)00098-4/fulltext

Epidural analgesia versus dural puncture ...

The DPE technique was found to be 50% more effective in providing adequate pain relief compared with traditional epidural analgesia. Furthermore ...

4.

dovepress.com

dovepress.com/labor-analgesia-initiation-with-dural-puncture-epidural-versus-standar-peer-reviewed-fulltext-article-DDDT

Labor Analgesia Initiation with Dural Puncture Epidural ...

Recently, the DPE technique was found to lower the effective dose for 90% (ED90) of patients receiving bupivacaine for labor analgesia by 35%.

5.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2807803

Effect of Dural-Puncture Epidural vs Standard ...

A recent meta-analysis from 2022 reported faster onset to satisfactory pain relief in women receiving DPE labor analgesia. Since then, a large ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11556960/

Effect of dural puncture epidural technique combined with ...

Studies have shown that DPE is a safe and effective technique for labor analgesia. It provides faster and more adequate analgesia than EP.

7.

withpower.com

withpower.com/trial/phase-labor-pain-11-2023-24910

Bupivacaine for Labor Pain

Studies show that bupivacaine, when used in low concentrations for labor pain relief, is generally safe with minimal side effects. It is comparable to ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03366935

Combined Implementation of Dural Puncture Epidural and ...

We designed this prospective randomized, double-blind study to evaluate the safety and efficacy of the combined implementation of DPE technique and PIEB for ...