120 Participants Needed

Bupivacaine for Labor Pain

LT
AM
Overseen ByAyumi Maeda, MD
Age: Any Age
Sex: Female
Trial Phase: Phase 4
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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 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.12345

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.26789

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.210111213

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.

Eligibility Criteria

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.
See 2 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Active Control
Group I: DPE GroupActive Control1 Intervention
Subjects will receive an epidural catheter via a dural puncture epidural technique.
Group II: EPL GroupActive Control1 Intervention
Subjects will receive an epidural catheter via a traditional epidural technique.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Findings from Research

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

References

Effect of second-stage 0.25% epidural bupivacaine on the outcome of labor. [2018]
Comparative evaluation of four different infusion rates of ropivacaine (2 mg/mL) for epidural labor analgesia. [2019]
A randomized comparison of levobupivacaine, bupivacaine and ropivacaine with fentanyl, for labor analgesia. [2018]
[Influence of epidural ropivacaine in combination with fentanyl for labor analgesia on the clinical outcome of labor]. [2018]
[Comparison of ropivacaine and bupivacaine for epidural analgesia during labor]. [2018]
Comparison of maternal and neonatal outcomes with epidural bupivacaine plus fentanyl and ropivacaine plus fentanyl for labor analgesia. [2018]
An analysis of the need for anesthetic interventions with differing concentrations of labor epidural bupivacaine: an observational study. [2013]
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]
0.125% ropivacaine is similar to 0.125% bupivacaine for labor analgesia using patient-controlled epidural infusion. [2022]
In vivo comparison of the effects of bupivacaine and levobupivacaine on the pregnant rat myometrium using electrohysterogram. [2018]
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]
Comparison of bupivacaine and ropivacaine in combination with fentanyl used for walking epidural anesthesia in labor. [2022]
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