NCT04946032Completed
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
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 25 Jun 2021
- Start date
- 23 Nov 2021
- Primary completion date
- 26 Jul 2024
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Diseases
- Obesity
- NCT number
- NCT04946032
What you commit to
- Study type: Interventional
- Participants enrolled: 200
- From 23 Nov 2021 to the primary completion date, 26 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous difficult epidural insertion.
- Previous failed epidural.
Other
- Known contraindication to epidural insertion.
- Inability or unwillingness to provide written consent.
- Imminent instrumental or operative delivery.
- Dural puncture.
- Combined spinal epidural analgesia.
- High BMI \> 40 kg/m2
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mount Sinai Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.