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

Last updated: April 2, 2025
Sponsor: The Rotunda Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Epidural Analgesia

Clinical Study ID

NCT06850636
REC-2024-027
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Women electing to have epidural analgesia in labour

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 162
Treatment Group(s): 1
Primary Treatment: Epidural Analgesia
Phase:
Study Start date:
February 25, 2025
Estimated Completion Date:
September 30, 2025

Study 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).

Connect with a study center

  • The Rotunda Hospital, Dublin

    Dublin, D06X898
    Ireland

    Active - Recruiting

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