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

NCT06850636 | Recruiting

• 1 other identifier: REC-2024-027
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labour Analgesia, Epidural Anaesthesia

Outcome Measures

Primary Outcomes (1)

• Composite outcome: Failure of Labour epidural catheter or PIEB protocol

  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 Outcomes (6)

• Pain score

  60 minutes post delivery and at postnatal follow up.

• Dermatomal sensory level assessed using cold sensation

  60 minutes after insertion of the epidural catheter

• Bromage score

  60 minutes after insertion of labour epidural catheter

• Patient Satisfaction

  At follow up visit within 24 hours

• Depth of the epidural space

  At time of insertion

Study Arms (2)

Epidural analgesia performed at a higher lumbar epidural level

ACTIVE COMPARATOR

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

Epidural analgesia performed at a lower lumbar epidural level

ACTIVE COMPARATOR

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

Interventions

Epidural Analgesia PROCEDURE

Labour epidural analgesia

Epidural analgesia performed at a higher lumbar epidural level; Epidural analgesia performed at a lower lumbar epidural level

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women electing to have epidural analgesia in labour

You may not qualify if:

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

Sponsors & Collaborators

• The Rotunda Hospital: lead

Study Sites (1)

The Rotunda Hospital, Dublin

Dublin, Dublin, D06X898, Ireland

RECRUITING

MeSH Terms

Interventions

Analgesia, Epidural

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Central Study Contacts

Thomas Drew, FCAI

CONTACT

018171753; tdrew@rotunda.ie

Mohamed Mostafa

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Consultant Anaesthesiologist

Model Details: 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 Record Dates

• First Submitted: February 18, 2025
• First Posted: February 27, 2025
• Study Start: February 25, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)