Epidural Analgesia Techniques for Labor Pain

Overseen By Isabelle Caron, Dr.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Must not be taking: Fentanyl

Disqualifiers: Preeclampsia, Eclampsia, Gestational diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods of managing labor pain using epidural analgesia. It compares a continuous flow of pain relief medication (Continuous Infusion) with a method that administers doses at intervals (Programmed Intermittent Epidural Bolus). Researchers aim to determine if the interval method uses less medication overall. Pregnant women in early labor, planning to use epidural pain relief and without certain medical conditions like gestational diabetes or multiple pregnancies, may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to important research that could enhance pain management options for future mothers.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have any pregnancy-related conditions or a history of chronic pain, you may not be eligible to participate.

What prior data suggests that these epidural analgesia techniques are safe for labor pain management?

Research has shown that a programmed intermittent epidural bolus (PIEB) for labor pain offers certain safety benefits. Studies have found that PIEB is associated with fewer unexpected doctor visits and a lower incidence of muscle weakness compared to continuous epidural infusion (CEI). Specifically, muscle weakness occurred in about 22% of cases with PIEB, compared to about 28% with CEI.

Patients using PIEB also reported higher satisfaction during labor. There were no significant differences in cesarean delivery rates, indicating that PIEB did not lead to more serious interventions.

Overall, PIEB appears well-tolerated and offers advantages over traditional methods like CEI, suggesting it is a safe option for managing labor pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring new epidural analgesia techniques for labor pain because these methods could offer more effective pain management. Unlike the traditional continuous infusion, which provides a steady flow of medication, the programmed intermittent epidural bolus technique delivers medication at set intervals. This approach might enhance pain relief and reduce the total amount of medication needed, potentially leading to fewer side effects for both the mother and baby. Additionally, combining it with patient-controlled analgesia gives mothers more control over their pain management during labor.

What evidence suggests that this trial's treatments could be effective for labor pain?

This trial will compare two epidural analgesia techniques for labor pain: the continuous infusion method and the programmed intermittent epidural bolus (PIEB) method. Studies have shown that PIEB effectively manages labor pain. Research indicates that PIEB often leads to lower pain levels and reduces the need for additional pain relief. It also tends to increase maternal satisfaction. Compared to continuous infusion, PIEB may use less medication and result in fewer assisted deliveries, although results can vary. Overall, PIEB appears promising for providing effective pain relief during labor. ^{5 6 7 8 9}

Who Is on the Research Team?

Geneviève Rivard, Dr.

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

This trial is for pregnant women in labor, whether it's their first child or not. They must be at least 18 years old and have agreed to epidural pain relief. Their overall health should be good to moderately impaired (ASA I-III), and they need to be in early labor with a cervical dilation of 6cm or less.

Inclusion Criteria

I am pregnant and in labor, regardless of how many times I've been pregnant before.

You are in the early stages of labor and your cervix has dilated up to 6cm.

I have agreed to receive pain relief through an epidural.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a programmed intermittent epidural bolus or continuous infusion combined with patient-controlled epidural analgesia during labor

1 day

In-person during labor

Follow-up

Participants are monitored for outcomes such as cesarean section, patient satisfaction, and pain evaluation

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Infusion
• Programmed Intermittent Epidural Bolus

Trial Overview

The study is testing two methods of delivering pain medication through an epidural during labor: one group will receive the drug bupivacaine continuously, while the other will get programmed intermittent doses plus control over additional dosing as needed.

How Is the Trial Designed?

Group I: Study group Experimental Treatment 1 Intervention

Programmed intermittent epidural bolus + patient controlled analgesia

Group II: Control group Active Control 1 Intervention

Continuous infusion + patient controlled epidural analgesia

Continuous Infusion is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Continuous Epidural Infusion for:

• Labour analgesia

Approved in United States as Continuous Epidural Infusion for:

• Labour analgesia

Approved in Canada as Continuous Epidural Infusion for:

• Labour analgesia

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Published Research Related to This Trial

In a study comparing two methods of labor analgesia, programmed intermittent epidural boluses (PIEB) resulted in fewer women needing rescue clinician boluses (12% vs. 19%) compared to continuous epidural infusion (CEI), indicating better pain management with PIEB.

PIEB provided comparable pain relief during labor, with median pain scores of 0 for PIEB versus 2 for CEI, suggesting that PIEB may be a more effective and preferable technique for maintaining labor analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed intermittent epidural boluses for maintenance of labor analgesia: an impact study. McKenzie, CP., Cobb, B., Riley, ET., et al.[2022]

Intermittent epidural bolus (IEB) for labor analgesia resulted in a small but significant reduction in local anesthetic usage compared to continuous epidural infusion (CEI), suggesting a more efficient use of medication.

Maternal satisfaction scores were higher with IEB compared to CEI, indicating that women may prefer this method for pain relief during labor, although further research is needed to confirm its effects on other labor outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. George, RB., Allen, TK., Habib, AS.[2022]

The programmed intermittent epidural bolus (PIEB) technique significantly reduced local anesthetic consumption compared to the continuous epidural infusion (CEI) method in patients undergoing major abdominal cancer surgery, with median PCEA bolus volumes of 10 mL for PIEB versus 28 mL for CEI.

Despite the reduced local anesthetic use in the PIEB group, pain scores remained comparable between the two groups, indicating that PIEB can maintain effective pain management while using less medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed intermittent epidural bolus versus continuous epidural infusion for postoperative analgesia after major abdominal and gynecological cancer surgery: a randomized, triple-blinded clinical trial. Wiesmann, T., Hoff, L., Prien, L., et al.[2019]

In a study of 221 primiparous women, the combination of programmed intermittent epidural bolus (PIEB) and patient-controlled epidural analgesia (PCEA) resulted in significantly fewer cesarean sections (5% vs. 14%) compared to continuous epidural infusion (CEI), indicating a safer delivery method.

The PIEB+PCEA group also required a lower total dose of ropivacaine, suggesting improved analgesic efficacy without increasing motor block, and overall maternal satisfaction was high.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Labor outcomes with epidural analgesia: an observational before-and-after cohort study comparing continuous infusion versus programmed intermittent bolus plus patient-controlled analgesia. Holgado, CM., Girones, A., Tapia, N., et al.[2021]

In a study of 150 patients, the programmed intermittent epidural bolus (PIEB) technique with 10 ml every 60 minutes (Group 10q60) resulted in significantly fewer patients needing physician-administered boluses for breakthrough pain compared to other regimens, indicating improved management of pain during labor.

Although overall pain scores and patient satisfaction were similar across all groups, the PIEB technique may offer a more effective approach to maintaining labor analgesia with less reliance on additional interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed intermittent epidural bolus as compared to continuous epidural infusion for the maintenance of labor analgesia: a prospective randomized single-blinded controlled trial. Fidkowski, CW., Shah, S., Alsaden, MR.[2020]

In a study of 145 women in labor, the Programmed Intermittent Epidural Anesthetic Bolus (PIEB) technique significantly reduced the incidence of motor block to 2.7%, compared to 37% in the Continuous Epidural Infusion (CEI) group, indicating a safer option for maintaining labor analgesia.

PIEB also led to fewer instrumental deliveries (7% vs. 20% in CEI) and lower total local anesthetic consumption, suggesting it may enhance patient satisfaction while effectively managing pain during labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed intermittent epidural bolus versus continuous epidural infusion for labor analgesia: the effects on maternal motor function and labor outcome. A randomized double-blind study in nulliparous women. Capogna, G., Camorcia, M., Stirparo, S., et al.[2022]

In a study of 90 term nulliparous women in labor, a slower delivery speed of 125 mL·hr-1 for programmed intermittent epidural bolus (PIEB) did not result in lower sensory block levels compared to a faster speed of 250 mL·hr-1.

However, the slower delivery speed was associated with a significantly lower incidence of hypotension (11.1% vs 33.3%), suggesting a potential safety benefit that needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed intermittent epidural bolus for labour analgesia: a randomized controlled trial comparing bolus delivery speeds of 125 mL·hr-1 versus 250 mL·hr-1. Mazda, Y., Arzola, C., Downey, K., et al.[2022]

In a study of 132 laboring women, those receiving programmed intermittent epidural boluses required significantly less anesthetic (24.9 mL) compared to those on continuous epidural infusion (34.4 mL), indicating a more efficient use of medication.

Both techniques provided similar pain control and did not differ in terms of maternal satisfaction, side effects, or newborn outcomes, suggesting that programmed intermittent boluses can be a safe and effective alternative for labor analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of programmed intermittent epidural boluses and continuous epidural infusion on labor analgesia and obstetric outcomes: a randomized controlled trial. Ferrer, LE., Romero, DJ., Vásquez, OI., et al.[2022]

Citations

1.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK596204/

Evidence reviews for programmed intermittent epidural bolus

The aim of this review was to determine if PIEB provides safe and effective maintenance of epidural analgesia in women in labour.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S095281802300315X

Influence of different volumes and frequency ...

PIEB has been associated with decreased pain scores and need for rescue analgesia and increased maternal satisfaction.

3.

cureus.com

cureus.com/articles/381075-mapping-the-effectiveness-of-programmed-intermittent-epidural-bolus-versus-continuous-epidural-infusion-for-labor-analgesia-a-scoping-review

Mapping the Effectiveness of Programmed Intermittent ...

The IEB group reported higher satisfaction. Moreover, instrumental delivery rates were lower in the IEB group and were not significant. Cesarean ...

4.

rapm.bmj.com

rapm.bmj.com/content/70/Suppl_1/A53.1

99 Programmed Intermittent Epidural Boluses (PIEB) for ...

The aim of this study was to compare the analgesic efficacy of PIEB technique and traditional techniques of epidural analgesia for labor pain relief.

5.

nature.com

nature.com/articles/s41598-019-39248-5

A Systematic Review and Meta-Analysis Comparing ...

The programmed intermittent epidural bolus (PIEB) technique offers multiple benefits over continuous epidural infusion (CEI), but controversy still exists.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11205856/

Programmed Intermittent Epidural Bolus Reduces ...

In our study, we found that PIEB substituting for CEI resulted in a 6.9% reduction in women requiring unscheduled visits, as well as the pain ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8812607/

Programmed intermittent epidural bolus in parturients

The outcomes were the effect of analgesia, satisfaction score, mode of delivery, duration of labor, neonatal condition, and adverse events.

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0959289X24002279

a retrospective study of motor block and obstetric outcomes ...

Use of a programmed intermittent epidural bolus (PIEB) regimen during labour is associated with several benefits over a continuous epidural infusion (CEI).

9.

obstetanesthesia.com

obstetanesthesia.com/article/S0959-289X(24)00227-9/abstract

Programmed intermittent epidural bolus regimen vs ...

Introduction of PIEB was associated with reduced incidence of motor block (28.4% (95% CI 25.7% to 31.3%) vs 22.4%, (95% CI 19.9% to 25.2%), ...