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

ConditionLabour Analgesia, Epidural Anaesthesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorThe Rotunda Hospital

About this trial

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

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Epidural Analgesia

    Procedure/Surgery

    Labour epidural analgesia

Treatment groups

162 Participants
are divided into 2 treatment groups
Group A: Epidural analgesia performed at a higher lumbar epidural levelActive comparator 1 intervention
Group B: Epidural analgesia performed at a lower lumbar epidural levelActive comparator 1 intervention

Trial outcomes

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

Time frame
During labour

Secondary outcomes

1

Pain score

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.

Time frame
60 minutes post delivery and at postnatal follow up.
2

Dermatomal sensory level assessed using cold sensation

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.

Time frame
60 minutes after insertion of the epidural catheter
3

Bromage score

Motor block assessed at 60 minutes

Time frame
60 minutes after insertion of labour epidural catheter
4

Patient Satisfaction

Patient satisfaction assessed at follow up visit, assessed using a scale of 0-10 where 0 is extremely dissatisfied and 10 is extremely satisfied.

Time frame
At follow up visit within 24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Rotunda Hospital

Lead sponsor

Source ClinicalTrials.gov
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