Labour Analgesia, Epidural AnaesthesiaNCT06850636
Higher vs Lower Lumber Epidural Catheter Insertion During Labour: A Randomised Trial to Compare Efficacy.
A study testing Epidural Analgesia in people with Labour Analgesia, Epidural Anaesthesia, run by The Rotunda Hospital at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labour Analgesia, Epidural Anaesthesia
- What is being tested?
- Epidural Analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteIreland
- Study dates
- 25 Feb 2025to 5 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women undergoing induction of labour who plan to have epidural analgesia
Who cannot join
- Known contraindication to epidural analgesia. Neurological illness Multiple gestation Fetal abnormalities In distress or requiring immediate epidural catheter placement
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Labour Analgesia, Epidural Anaesthesia
- Being tested
- Epidural Analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural AnalgesiaProcedure or surgery
Labour epidural analgesia
| Study group | Role | What they receive |
|---|---|---|
| Epidural analgesia performed at a higher lumbar epidural level | Active comparator | Epidural analgesia performed using Programmed Intermittent Epidural Boluses using an epidural catheter at a higher lumbar epidural level sited at L1,L2 or L2,L3 Receives: Procedure: Epidural Analgesia |
| Epidural analgesia performed at a lower lumbar epidural level | Active comparator | Epidural analgesia performed using Programmed Intermittent Epidural Boluses using an epidural catheter sited at lower epidural level (L3,L4 or L4,L5) Receives: Procedure: Epidural Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During labour
Secondary outcomes (6)
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.
Measured: 60 minutes post delivery and at postnatal follow up.
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.
Measured: 60 minutes after insertion of the epidural catheter
Bromage score
Motor block assessed at 60 minutes
Measured: 60 minutes after insertion of labour epidural catheter
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.
Measured: At follow up visit within 24 hours
Depth of the epidural space
The depth to the epidural space in cm
Measured: At time of insertion
Difficulty 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.
Measured: At time of epidural insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start25 Feb 2025
- Primary completion4 Jan 2026
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour Analgesia, Epidural AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Rotunda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Drew, The Rotunda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850636
- Sponsor's protocol ID
- REC-2024-027
- Status last verified
- Aug 2026
- First submitted
- 18 Feb 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Higher vs Lower Lumber Epidural Catheter Insertion During Labour: A Randomised Trial to Compare Efficacy.
- ClinicalTrials.gov ID
- NCT06850636
- Acronym / sponsor ID
- REC-2024-027
- Conditions
- Labour Analgesia, Epidural Anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- The Rotunda HospitalUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 4 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Epidural analgesia performed at a higher lumbar epidural level | Active comparator | Procedure: Epidural AnalgesiaEpidural analgesia performed using Programmed Intermittent Epidural Boluses using an epidural catheter at a higher lumbar epidural level sited at L1,L2 or L2,L3 |
| Epidural analgesia performed at a lower lumbar epidural level | Active comparator | Procedure: Epidural AnalgesiaEpidural analgesia performed using Programmed Intermittent Epidural Boluses using an epidural catheter sited at lower epidural level (L3,L4 or L4,L5) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing induction of labour who plan to have epidural analgesia
Key exclusion criteria (1 listed)
- Known contraindication to epidural analgesia. Neurological illness Multiple gestation Fetal abnormalities In distress or requiring immediate epidural catheter placement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural AnalgesiaLabour epidural analgesia | Procedure or surgery | Epidural analgesia performed at a higher lumbar epidural level, Epidural analgesia performed at a lower lumbar epidural level |
Primary outcome
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
6 secondary outcomes
Pain score
Time frame: 60 minutes post delivery and at postnatal follow up.
Dermatomal sensory level assessed using cold sensation
Time frame: 60 minutes after insertion of the epidural catheter
Bromage score
Time frame: 60 minutes after insertion of labour epidural catheter
Patient Satisfaction
Time frame: At follow up visit within 24 hours
Depth of the epidural space
Time frame: At time of insertion
Difficulty of epidural insertion
Time frame: At time of epidural insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural Analgesia in people with Labour Analgesia, Epidural Anaesthesia, run by The Rotunda Hospital at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome: Failure of Labour epidural catheter or PIEB protocol (time frame: During labour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.