Higher vs Lower Lumber Epidural Catheter Insertion During Labour: A Randomised Trial to Compare Efficacy.

August 13, 2026 updated by: Tom Drew, The Rotunda Hospital
This study will randomise pregnant women to labour epidural at a higher versus a lower lumbar level. Outcomes relating to success or failure of the epidural catheter at this level will be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Epidural analgesia is widely used in different types of surgeries and procedures. Pregnant women in labour compromise the single largest group benefiting from epidural analgesia. During first stage of labour (dilatation of the cervix), an epidural should cover the sensory dermatomes from T10 to L1 to achieve a good pain relief. In the second stage of labour (descent of the baby through the cervical canal), pain is mediated via S2-S4 nerve roots. Accordingly, labour epidurals are commonly placed at the lower lumbar (L3-L4) interspace.1 A study was conducted by Moore et al., comparing high vs low lumbar epidural, showed that lower epidurals provide superior perineal analgesia, when used with a patient-controlled epidural analgesia (PCEA) infusion with continuous epidural infusion (CEI), but provided less pain relief early in labour. Another study, a metanalysis showed that another mode of delivery of the local anaesthetics is more effective; which is the Programmed Intermittent Epidural Boluses (PIEB) with PCEA. The incidence of breakthrough pain, the rates of local anaesthetic usage were significantly reduced, the labour duration was statistically shorter, and the maternal satisfaction score was significantly improved in the PIEB + PCEA group compared with that in the CEI + PCEA group.

This is a prospective randomised study where women will be randomised to a high or low epidural catheter to determine which is superior for maternal analgesia efficacy and satisfaction.

Randomised to intervention 'high epidural' or 'low epidural' groups. Within these groups there are two subgroups based on the specific lumbar vertebral level; high epidural (L 1,2 or L 2,3 levels) and low epidural (L 3,4 or L 4,5 levels).

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • Dublin
      • Dublin, Dublin, Ireland, D06X898
        • The Rotunda Hospital, Dublin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Women undergoing induction of labour who plan to have epidural analgesia

Exclusion Criteria:

Known contraindication to epidural analgesia. Neurological illness Multiple gestation Fetal abnormalities In distress or requiring immediate epidural catheter placement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Epidural analgesia performed at a higher lumbar epidural level
Epidural analgesia performed using Programmed Intermittent Epidural Boluses using an epidural catheter at a higher lumbar epidural level sited at L1,L2 or L2,L3
Procedure: Epidural Analgesia
Labour epidural analgesia
Active Comparator: Epidural analgesia performed at a lower lumbar epidural level
Epidural analgesia performed using Programmed Intermittent Epidural Boluses using an epidural catheter sited at lower epidural level (L3,L4 or L4,L5)
Procedure: Epidural Analgesia
Labour epidural analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite outcome: Failure of Labour epidural catheter or PIEB protocol
Time Frame: During labour
Composite outcome of 1/Failure to insert labour epidural at the assigned level OR 2/ Labour epidural catheter requires resiting OR 3/ Healthcare worker top up due to pain OR 4/ Failure of epidural conversion to epidural anaesthesia if caesarean section required
During labour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: 60 minutes post delivery and at postnatal follow up.
Pain scores taken 60 minutes after insertion of epidural catheter and retrospective pain scores assessed during second stage of labour taken at follow up visit. Pain scores to be assessed using a visual analogue score of 0-10, where 0 is no pain at all and 10 is the worst pain.
60 minutes post delivery and at postnatal follow up.
Dermatomal sensory level assessed using cold sensation
Time Frame: 60 minutes after insertion of the epidural catheter
Dermatomal sensory level assessed 60 minutes after insertion of the epidural catheter using ice. Assessed by placing ice at the L1 dermatome, and move cranially or caudally until the patient notices a change in cold sensation.
60 minutes after insertion of the epidural catheter
Bromage score
Time Frame: 60 minutes after insertion of labour epidural catheter
Motor block assessed at 60 minutes
60 minutes after insertion of labour epidural catheter
Patient Satisfaction
Time Frame: At follow up visit within 24 hours
Patient satisfaction assessed at follow up visit, assessed using a scale of 0-10 where 0 is extremely dissatisfied and 10 is extremely satisfied.
At follow up visit within 24 hours
Depth of the epidural space
Time Frame: At time of insertion
The depth to the epidural space in cm
At time of insertion
Difficulty of epidural insertion
Time Frame: At time of epidural insertion
Difficulty of epidural insertion as perceived by the clinican, on a scale on 1-4 where 1 is easy and 4 is very difficult.
At time of epidural insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Rotunda Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2025

Primary Completion (Actual)

January 4, 2026

Study Completion (Actual)

January 5, 2026

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

February 22, 2025

First Posted (Actual)

February 27, 2025

Study Record Updates

Last Update Posted (Actual)

August 14, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-2024-027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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