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

Trial Summary

What is the purpose of this trial?

Epidural analgesia was introduced to the world of obstetrics in 1909 by Walter Stoeckel. Over the following 100 years it has developed to become the gold-standard for delivery of intra-partum analgesia, with between 60 and 75% of North American parturients receiving an epidural during their labor. Effective labor analgesia has been shown to improve maternal and fetal outcomes. One aspect of catheter insertion that has not been fully evaluated, and with very little recent work undertaken, is the optimal length of epidural catheter to be left in the epidural space. Dislodgement or displacement of epidural catheter remains a significant cause for failure with analgesia. Novel methods of fixation may further reduce the risk of catheter migration. Another factor is the direction of travel within the epidural space, only 13% of lumbar catheters remain uncoiled after insertion of more than 4 cm into the epidural space. 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: This study aims to evaluate the difference in quality of labor analgesia delivered by epidural catheters inserted to either 4 or 5 cm into the epidural space. This study will be conducted as an interventional double-blinded randomised control trial to establish best practice.

Research Team

Mrinalini Balki, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Eligibility Criteria

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.

I am in the second stage of labor.

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

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

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

Treatment Details

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.

Participant Groups

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+