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

200 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Epidural Analgesia Techniques for Labor Pain?

Research shows that the programmed intermittent epidural bolus (PIEB) technique can improve labor pain relief and reduce the need for additional manual doses compared to continuous epidural infusion (CEI). PIEB is associated with better pain management and patient satisfaction during labor. ^{1 2 3 4 5}

Is epidural analgesia safe for labor pain?

Research shows that both programmed intermittent epidural bolus (PIEB) and continuous epidural infusion (CEI) are generally safe for managing labor pain. Studies indicate that PIEB may lead to fewer side effects like reduced motor block (less muscle weakness) and greater patient satisfaction compared to CEI. ^{1 2 3 5 6}

How does the treatment Programmed Intermittent Epidural Bolus (PIEB) differ from other treatments for labor pain?

Programmed Intermittent Epidural Bolus (PIEB) is unique because it delivers pain relief in timed doses rather than a continuous flow, which can reduce the risk of motor block (muscle weakness) and improve labor outcomes compared to the traditional continuous epidural infusion (CEI). This method can also be combined with patient-controlled options, allowing for more personalized pain management during labor. ^{1 2 6 7 8}

What is the purpose of this trial?

This study aims to establish if programmed intermittent epidural bolus combined to patient controlled analgesia in labour analgesia will lower the hourly bupivacaine consumption when compared to continuous infusion combined with patient controlled analgesia. The investigators' hypothesis is that the use of programmed intermittent epidural bolus will lower the hourly bupivacaine consumption.

Research Team

Geneviève Rivard, Dr.

Principal Investigator

Université de Sherbrooke

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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]

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]

References

1. Korea (South) 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. [2020]

2. Italy 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. [2021]

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

Programmed intermittent epidural boluses for maintenance of labor analgesia: an impact study. [2022]

4. England 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. [2019]

5. United States 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. [2022]

6. United States 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. [2022]

7. Germany 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. [2022]

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

Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. [2022]