The Rotunda Hospital, Dublin
Dublin, D06X898, Ireland
Location status: Recruiting
Recruiting
NCT Number: NCT06850636
Higher vs Lower Lumber Epidural Catheter Insertion During Labour: A Randomised Trial to Compare Efficacy.
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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).
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Epidural Analgesia
ProcedureLabour epidural analgesia
Primary outcomes
-
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
Secondary outcomes
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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.
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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.
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Bromage score
Time frame: 60 minutes after insertion of labour epidural catheter
Motor block assessed at 60 minutes
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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.
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Depth of the epidural space
Time frame: At time of insertion
The depth to the epidural space in cm
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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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
The Rotunda Hospital
Other
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Feb 27, 2025
- Registry last updated
- Apr 3, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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