Optimum Length of Catheter in the Epidural Space for Labor Analgesia in Non-obese Women: a Randomised Controlled Trial of 4 Cm Versus 5 Cm

NCT ID: NCT04946032

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-23
• Study Completion Date: 2025-06-30

Brief Summary

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.

Detailed Description

Effective labor analgesia has been shown to improve maternal and fetal outcomes. It is of paramount importance to the obstetric anesthesiologist to optimize the quality of labor analgesia and identify any factors leading to ineffective epidural analgesia. 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.

Previous studies have advocated, for varying reasons, different lengths of catheter to be left in the space; these range from 2cm to 8cm. Longer epidural lengths in the space can be associated with foraminal escape, leading to unilateral block, and intravascular insertion, prompting additional manipulation. Shorter lengths have previously been associated with more frequent dislodgement. The directionality of the epidural catheter once in the space has been demonstrated to correlate with misdirection.

The aim of the study would be to standardize practice in how much epidural catheter is threaded into the epidural space.

Conditions

Labor Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

4 cm epidural catheter

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

Group Type: ACTIVE_COMPARATOR

Epidural catheter

Intervention Type: OTHER

The epidural catheter length will vary, either 4 cm or 5 cm into the epidural space.

5 cm epidural catheter

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

Group Type: ACTIVE_COMPARATOR

Epidural catheter

Intervention Type: OTHER

The epidural catheter length will vary, either 4 cm or 5 cm into the epidural space.

Interventions

Epidural catheter

The epidural catheter length will vary, either 4 cm or 5 cm into the epidural space.

Intervention Type: OTHER

Other Intervention Names

epidural

Eligibility Criteria

Inclusion Criteria

• All women aged 18 years and above.
• In established second stage of labor.
• 3-7 cm dilation at time of insertion.
• Women with BMI < 40 kg/m2

Exclusion Criteria

• Known contraindication to epidural insertion.
• Inability or unwillingness to provide written consent.
• Previous difficult epidural insertion.
• Previous failed epidural.
• Imminent instrumental or operative delivery.
• Dural puncture.
• Combined spinal epidural analgesia.
• High BMI > 40 kg/m2

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mrinalini Balki, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Mrinalini Balki, MD

Role: CONTACT

mrinalini.balki@uhn.ca

416-586-4800 ext. 5270

Facility Contacts

Mrinalini Balki, MD

Role: primary

mrinalini.balki@uhn.ca

416-586-4800 ext. 5270

William Turner, MD

Role: backup

Linda Boonstra-Verbraak, MD

Role: backup

Kristi Downey, MSc

Role: backup

Naveed Siddiqui, MD

Role: backup

Other Identifiers

21-06

Identifier Type: -

Identifier Source: org_study_id