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

NCT04946032 | Recruiting

• 1 other identifier: 21-06
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

epidural catheter; epidural analgesia; labor epidural

Outcome Measures

Primary Outcomes (5)

• Sensory block level < T10

  Sensory block level to ice will be measured 1 hour after the loading dose is administered. Yes: inadequate block No: adequate block

  1 hour

• Block height discrepancy

  Unilateral block or block height discrepancy of \>3 dermatomal levels at any time prior to delivery. Yes: inadequate block No: adequate block

  24 hours

• Re-siting of the epidural

  Re-siting of the epidural at any time during labour will indicate an inadequate block, for any of the following reasons: * Inadequate analgesia * Persistent unilateral block * Persistent intravascular placement * Extensive motor block * Hypotension * High block

  24 hours

• Adjustment of catheter length

  Adjustment of catheter length at any time during labour would also indicate an inadequate block.

  24 hours

• Abandonment of epidural or substitute for alternative method of analgesia after initial failure: questionnaire

  The epidural analgesia will also be considered inadequate if the procedure is abandoned or another method of analgesia is used. This will be recorded by the anesthesiologist.

  24 hours

Secondary Outcomes (10)

• Pain score >3 at any time during labour: questionnaire

  24 hours

• Number of epidural top-ups administered by the nursing team

  24 hours

• Number of epidural top-ups administered by the anesthesiologist

  24 hours

• Pain scores recorded throughout labour: questionnaire

  24 hours

• Hourly sensory block height assessment

  24 hours

Study Arms (2)

4 cm epidural catheter

ACTIVE COMPARATOR

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

Other: Epidural catheter

5 cm epidural catheter

ACTIVE COMPARATOR

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

Other: Epidural catheter

Interventions

Epidural catheter OTHER

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

Also known as: epidural

4 cm epidural catheter; 5 cm epidural catheter

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

RECRUITING

MeSH Terms

Conditions

Labor Pain

Interventions

Injections, Epidural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mrinalini Balki, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mrinalini Balki, MD

CONTACT

416-586-4800; mrinalini.balki@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The anesthesiologist placing the epidural will know the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: June 30, 2021
• Study Start: November 23, 2021
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)