Labor AnalgesiaNCT00954317
Do Epidurals Placed at a Lower Level Improve Labor Analgesia?
A study testing epidural placed low and high epidural in people with Labor Analgesia, run by Royal Victoria Hospital, Canada at 1 site in Canada.
Trial summary
The investigators wish to compare the analgesia provided by epidurals placed high in the lumbar spine versus epidurals place low in the lumbar spine. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Analgesia
- What is being tested?
- epidural placed low and high epidural
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Jan 2014
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women in active labor
Who cannot join
- known contraindications to epidural analgesia
- moderate to severe systemic illness as evidenced by an American Society of Anesthesiologists (ASA) score of 3 or higher.
- known abnormalities of the spinal column
- any neurologic illness
- multiple gestations, fetal abnormalities or fetal presentation other than vertex
- recent history of analgesic usage
Show all 9Show fewer
- an inability to communicate in English or French
- Body Mass Index greater than 40
- patients in pain requesting an immediate epidural
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
albert r moore, md
About this study
Official title: Do Epidurals Placed at a Lower Level Improve Labour Analgesia
The investigators wish to compare the analgesia provided by epidurals placed high in the lumbar spine versus epidurals place low in the lumbar spine.
- Conditions
- Labor Analgesia
- Being tested
- epidural placed low, high epidural
- Keywords
- epidural, labour analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural placed lowProcedure or surgery
epidural placed low
high epiduralProcedure or surgery
high epidural
| Study group | Role | What they receive |
|---|---|---|
| Low epidural | Active comparator | epidural placed in the lower lumbar vertebral column Receives: Procedure: epidural placed low |
| high epidural | Experimental | high epidural Receives: Procedure: high epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of epidural medication boluses required
Measured: 30 minutes and 1 hour
Secondary outcomes (1)
Labour progress
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor AnalgesiaStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Victoria Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Moore, Royal Victoria Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954317
- Sponsor's protocol ID
- SDR-08-052
- Status last verified
- Nov 2012
- First submitted
- 5 Aug 2009
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Moore A, Villeneuve V, Bravim B, El-Bahrawy A, El-Mouallem E, Kaufman I, Hatzakorzian R, Li Pi Shan W. The Labor Analgesia Requirements in Nulliparous Women Randomized to Epidural Catheter Placement in a High or Low Intervertebral Space. Anesth Analg. 2017 Dec;125(6):1969-1974. doi: 10.1213/ANE.0000000000002076.
PubMed 28504988
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Epidurals Placed at a Lower Level Improve Labour Analgesia
- ClinicalTrials.gov ID
- NCT00954317
- Acronym / sponsor ID
- SDR-08-052
- Conditions
- Labor Analgesia
- Keywords
- epidural, labour analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Royal Victoria Hospital, CanadaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 7 Aug 2009 (estimated)
- 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.
The investigators wish to compare the analgesia provided by epidurals placed high in the lumbar spine versus epidurals place low in the lumbar spine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low epidural | Active comparator | Procedure: epidural placed lowepidural placed in the lower lumbar vertebral column |
| high epidural | Experimental | Procedure: high epiduralhigh epidural |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women in active labor
Key exclusion criteria (9 listed)
- known contraindications to epidural analgesia
- moderate to severe systemic illness as evidenced by an American Society of Anesthesiologists (ASA) score of 3 or higher.
- known abnormalities of the spinal column
- any neurologic illness
- multiple gestations, fetal abnormalities or fetal presentation other than vertex
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 placed lowepidural placed low | Procedure or surgery | Low epidural |
| high epiduralhigh epidural | Procedure or surgery | high epidural |
Primary outcome
Number of epidural medication boluses required
Time frame: 30 minutes and 1 hour
1 secondary outcome
Labour progress
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2012.
- Derived from this study: PubMed 28504988Moore A, Villeneuve V, Bravim B, El-Bahrawy A, El-Mouallem E, Kaufman I, Hatzakorzian R, Li Pi Shan W. The Labor Analgesia Requirements in Nulliparous Women Randomized to Epidural Catheter Placement in a High or Low Intervertebral Space. Anesth Analg. 2017 Dec;125(6):1969-1974. doi: 10.1213/ANE.0000000000002076.
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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.
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 placed low and high epidural in people with Labor Analgesia, run by Royal Victoria Hospital, Canada at 1 site in Canada.
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 9 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: status not confirmed, as of the sponsor's last update on 30 Nov 2012. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact albert r moore, md (514.934.1934 ext. 34880, moore_albert@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of epidural medication boluses required (time frame: 30 minutes and 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00954317, which also lists 1 linked publication.
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 30 Nov 2012.