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?

The primary objective of our study is to use a biased coin up-down allocation methodology to estimate the dose of bupivacaine required after the lidocaine test dose to achieve initial effective comfort in 90% of patients (post test-dose ED90) via the epidural (DPE or EPL) technique in women undergoing labor induction or augmentation; the investigators hypothesize that the investigators will be able to determine the post test-dose ED90 of bupivacaine for each technique with adequate precision to inform the optimal doses to study in a subsequent randomized trial comparing the analgesic effects of DPE vs. EPL. The investigators also hypothesize that the post test-dose ED90 of bupivacaine is lower with a DPE technique than with a conventional epidural technique.

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.

Is bupivacaine safe for use in labor pain management?

Studies show that bupivacaine, when used in low concentrations for labor pain relief, is generally safe with minimal side effects. It is comparable to ropivacaine, another pain relief medication, in terms of safety and effectiveness. ^{1 2 3 4 5}

How does the drug bupivacaine differ from other drugs for labor pain?

Bupivacaine is unique because it provides effective pain relief during labor with less motor block compared to some other local anesthetics, which means it allows for more movement. It is often used in combination with other drugs like morphine or fentanyl to enhance pain relief while minimizing side effects. ^{3 6 7 8 9}

What data supports the effectiveness of the drug Bupivacaine for labor pain?

Research shows that Bupivacaine is effective for labor pain relief, as it has been compared to similar drugs like ropivacaine and found to provide comparable pain relief during labor. ^{3 10 11 12 13}

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 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 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]

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 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 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 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 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 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 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]

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 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]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of second-stage 0.25% epidural bupivacaine on the outcome of labor. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Comparative evaluation of four different infusion rates of ropivacaine (2 mg/mL) for epidural labor analgesia. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized comparison of levobupivacaine, bupivacaine and ropivacaine with fentanyl, for labor analgesia. [2018]

4. China pubmed.ncbi.nlm.nih.gov

[Influence of epidural ropivacaine in combination with fentanyl for labor analgesia on the clinical outcome of labor]. [2018]

5. Spain pubmed.ncbi.nlm.nih.gov

[Comparison of ropivacaine and bupivacaine for epidural analgesia during labor]. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of maternal and neonatal outcomes with epidural bupivacaine plus fentanyl and ropivacaine plus fentanyl for labor analgesia. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

An analysis of the need for anesthetic interventions with differing concentrations of labor epidural bupivacaine: an observational study. [2013]

8. India 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. [2020]

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

0.125% ropivacaine is similar to 0.125% bupivacaine for labor analgesia using patient-controlled epidural infusion. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

In vivo comparison of the effects of bupivacaine and levobupivacaine on the pregnant rat myometrium using electrohysterogram. [2018]

11. China pubmed.ncbi.nlm.nih.gov

Comparison of bupivacaine, ropivacaine and levobupivacaine with sufentanil for patient-controlled epidural analgesia during labor: a randomized clinical trial. [2018]

12. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

The efficacy of intrathecal coadministration of morphine and bupivacaine for labor analgesia. [2015]

13. Turkey pubmed.ncbi.nlm.nih.gov

Comparison of bupivacaine and ropivacaine in combination with fentanyl used for walking epidural anesthesia in labor. [2022]