Epidural Analgesia Techniques for Labor Pain

GR
IC
Overseen ByIsabelle Caron, Dr.
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Université de Sherbrooke
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.56789

Who Is on the Research Team?

GR

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.
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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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Study groupExperimental Treatment1 Intervention
Group II: Control groupActive Control1 Intervention

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

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Approved in European Union as Continuous Epidural Infusion for:
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Approved in United States as Continuous Epidural Infusion for:
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Approved in Canada as Continuous Epidural Infusion for:

Find a Clinic Near You

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.
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.
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.
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]

Citations

Evidence reviews for programmed intermittent epidural bolusThe aim of this review was to determine if PIEB provides safe and effective maintenance of epidural analgesia in women in labour.
Influence of different volumes and frequency ...PIEB has been associated with decreased pain scores and need for rescue analgesia and increased maternal satisfaction.
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 ...
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.
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.
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 ...
Programmed intermittent epidural bolus in parturientsThe outcomes were the effect of analgesia, satisfaction score, mode of delivery, duration of labor, neonatal condition, and adverse events.
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).
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%), ...
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