Labour Analgesia, Epidural Anaesthesia
Conditions
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).
Interventions
PROCEDUREEpidural Analgesia
Labour epidural analgesia
Sponsors
The Rotunda Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
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).
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite outcome: Failure of Labour epidural catheter or PIEB protocol | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain score | 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. |
| Dermatomal sensory level assessed using cold sensation | 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. |
| Bromage score | 60 minutes after insertion of labour epidural catheter | Motor block assessed at 60 minutes |
| Patient Satisfaction | 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. |
| Depth of the epidural space | At time of insertion | The depth to the epidural space in cm |
| Difficulty of epidural insertion | 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. |
Countries
Ireland
Outcome results
None listed