Clinical trial NCT06850636: Higher vs Lower Lumber Epidural Catheter Insertion During Labour: A Randomised Trial to Compare Efficacy.
Official title: Higher vs Lower Lumber Epidural Catheter Insertion During Labour: A Randomised Trial to Compare Efficacy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Labour Analgesia, Epidural Anaesthesia
Lead sponsor: The Rotunda Hospital
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 162
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: Inclusion Criteria:

Women electing to have epidural analgesia in labour

Exclusion Criteria:

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

Primary outcomes:
measure: Composite outcome: Failure of Labour epidural catheter or PIEB protocol
timeFrame: During labour
Secondary outcomes:
measure: Pain score
timeFrame: 60 minutes post delivery and at postnatal follow up.
measure: Dermatomal sensory level assessed using cold sensation
timeFrame: 60 minutes after insertion of the epidural catheter
measure: Bromage score
timeFrame: 60 minutes after insertion of labour epidural catheter
measure: Patient Satisfaction
timeFrame: At follow up visit within 24 hours
measure: Depth of the epidural space
timeFrame: At time of insertion
measure: Difficulty of epidural insertion
timeFrame: At time of epidural insertion
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: The Rotunda Hospital, Dublin
Study officials:
References: