Epidural Catheter for Labor Pain

Overseen By Mrinalini Balki, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Disqualifiers: Contraindication to epidural, High BMI, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 hours

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal use of epidural catheters for managing labor pain. Researchers are testing whether inserting the catheter 4 cm or 5 cm into the epidural space provides better pain relief. The goal is to determine which length offers the most effective and reliable pain management during labor. Women in the second stage of labor with a dilation of 3-7 cm and a BMI under 40 kg/m² may be eligible to participate. As an unphased trial, this study allows participants to contribute to improving labor pain management techniques.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this epidural catheter technique is safe for labor pain management?

Research shows that epidural pain relief effectively manages labor pain. Studies have found that it provides fast and effective relief for those who choose it. Both the 4 cm and 5 cm epidural catheter lengths are considered safe.

Epidural pain relief is widely used and generally safe, with most studies reporting it as effective for managing pain. However, pain can still occur in about 14-55% of cases, even with an epidural. In such instances, an anesthesiologist may need to provide additional assistance. Overall, epidural pain relief is usually well-tolerated and is a common choice for managing labor pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing epidural catheter lengths for labor pain management because it explores potential differences in effectiveness and comfort. Unlike standard epidural procedures, which typically use a fixed catheter length, this study examines both 4 cm and 5 cm insertions to see if one provides better pain relief or reduces complications. By fine-tuning the catheter length, this trial could lead to more personalized and effective pain management for women in labor, possibly improving the overall birthing experience.

What evidence suggests that this trial's epidural catheter lengths could be effective for labor pain?

Research has shown that epidurals effectively reduce labor pain. Studies have found that they relieve pain for most women who choose them, without increasing the risk of needing a C-section. Epidurals are widely recognized as a top choice for managing labor pain. This trial explores whether the length of the epidural catheter, either 4 cm or 5 cm, affects its effectiveness. Participants will receive either the 4 cm or 5 cm epidural catheter. The main goal is to determine if one length stays in place better and provides continuous pain relief. ^{1 2 6 7 8}

Who Is on the Research Team?

Mrinalini Balki, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Are You a Good Fit for This Trial?

This trial is for non-obese women over 18 years old in the second stage of labor, with a cervix dilation between 3-7 cm. They must not have had issues with epidurals before, be willing to consent, and should not be close to needing an instrumental or surgical delivery.

Inclusion Criteria

I am a woman aged 18 or older.

The opening of the cervix is between 3 to 7 centimeters wide when the insertion is done.

I am in the second stage of labor.

Exclusion Criteria

Inability or unwillingness to provide written consent

You had trouble getting an epidural in the past.

You are about to have a medical procedure or surgery to deliver a baby.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive epidural analgesia with catheters inserted to either 4 cm or 5 cm into the epidural space

24 hours

Continuous monitoring during labor

Follow-up

Participants are monitored for safety and effectiveness after the epidural procedure

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Epidural catheter

Trial Overview The study tests if there's a difference in pain relief during labor when an epidural catheter is inserted either 4 cm or 5 cm into the back space. It's a double-blinded trial where neither participants nor researchers know who gets which length until after results are collected.

How Is the Trial Designed?

Group I: 5 cm epidural catheter Active Control 1 Intervention

The epidural catheter will be thread into the epidural space at a length of 5 cm.

Group II: 4 cm epidural catheter Active Control 1 Intervention

The epidural catheter will be thread into the epidural space at a length of 4 cm.

Who Is Running the Clinical Trial?

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Lead Sponsor

Trials

132

Recruited

11,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04946032

Study Details | NCT04946032 | Optimum Length of ... Hypothesis: The investigators hypothesize that catheters inserted to 4 cm will have a lower rate of failure when compared to those inserted to 5 cm. Objective: ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9295827/

Effects of Epidural Analgesia on Labor Pain and Course ... Epidural analgesia alleviated labor pain in all primigravid parturients who opted for it, without an increase in cesarean section and instrumental vaginal ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S000293782200463X

Modern labor epidural analgesia: implications for ... Over its historic development, it has been implicated in several undesirable outcomes, including prolongation of labor and increased need for operative delivery ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12413817/

Effect of Epidural Catheter Design on Analgesic Efficacy ... Conclusion. Single-orifice catheters did not enhance analgesia quality during labor maintenance under a 360-mL/h programmed intermittent ...

5. janesthanalgcritcare.biomedcentral.com janesthanalgcritcare.biomedcentral.com/articles/10.1186/s44158-021-00003-w

Pain management during labor: use of intermittent drug ... Our study demonstrated that epidural anesthesia with programmed intermittent epidural boluses by an automated device provides an effective and safe management ...

6. ajog.org ajog.org/article/S0002-9378(22)00463-X/fulltext

implications for labor outcomes and maternal-fetal health Some forms of epidural analgesia were associated with higher risk of assisted vaginal delivery, but the use of newer modalities has been shown ...

7. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1361777/pdf

Pain control and neonatal outcomes in 211 women under ... Only 9% of mothers can tolerate labor pain (9). Epidural anesthesia effectively relieves labor pain (10,. 11). Most studies on epidural ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0959289X25003954

Factors associated with breakthrough pain during labor ... Breakthrough pain requiring anesthesiologist intervention occurs in 14–55% of parturients despite labor epidural analgesia, substantially ...