Labor PainNCT05126745
Assessment of Catheter Flow Direction Using Color Flow Doppler in Labor Epidurals
An observational study of Labor Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
Epidural analgesia is commonly used for pain relief in labor and involves placement of a catheter in the epidural space. Failure of epidural analgesia may occur in 12-16% of epidural catheter placements. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- color flow Doppler ultrasonography
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 17 Nov 2021to 6 Jun 2022
- Phase
- Observational
- 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 to 55 years
- Women only
- Adult
Study population: Women who have delivered under epidural analgesia, either with vaginal or caesarean delivery, will be approached for the study before the epidural catheter is removed.
Who may be able to join
- Women who have delivered under epidural analgesia
- Women who have vaginal or caesarean delivery
- Women with the epidural catheter still in place
Who cannot join
- -Women who experience fetal or maternal complications during delivery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Catheter Flow Direction Using Color Flow Doppler in Labor Epidurals: an Observational Study
Epidural analgesia is commonly used for pain relief in labor and involves placement of a catheter in the epidural space. Failure of epidural analgesia may occur in 12-16% of epidural catheter placements. It is defined as inadequate analgesia after the local anesthetic loading dose, despite use of appropriate dose/concentration of local anesthetic. Failure to provide adequate epidural analgesia is commonly caused by malposition of the epidural catheter. Many factors may influence the position of the tip of the epidural catheter and the resulting spread of local anesthetic into the epidural space, and consequently the quality of analgesia. Previously, X-ray exposure was required to assess catheter position in the epidural space. Recent developments have allowed the anesthesiologist to assess the catheter position at the bedside after its placement, using color flow Doppler ultrasonography.
The investigators will perform an observational study to determine epidural catheter flow direction in the obstetrical population using color flow Doppler ultrasound. Women who have delivered under epidural analgesia, either vaginal or caesarean delivery, will be approached for the study before the epidural catheter is removed.
The investigators aim to determine epidural flow relative to the insertion site, describe the findings and to correlate them with other clinical outcomes.
- Conditions
- Labor Pain
- Being tested
- color flow Doppler ultrasonography
- Keywords
- epidural catheter, epidural analgesia, labor epidural, ultrasound, Doppler
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
color flow Doppler ultrasonographyDevice
Doppler ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| Patients who had an epidural placed for labour | Patients who had an epidural placed for labour may take part. Study procedures will take place after delivery and prior to removal of the epidural catheter. Receives: Device: color flow Doppler ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization of flow relative to the interspace insertion level as assessed by color flow Doppler ultrasound
Visualization of flow relative to the interspace insertion level as assessed by color flow Doppler ultrasound (at insertion level [yes/no], above insertion level [yes/no], below insertion level [yes/no], no visualization of flow in any space).
Measured: 15 min
Secondary outcomes (9)
Level of epidural catheter insertion: questionnaire
The anesthesiologist will record the intervertebral level at which the epidural was placed: L2-L3, L3-L4
Measured: 5 min
Epidural regimen: questionnaire
Settings for the epidural pump as charted by the anesthesiologist and the nurse.
Measured: 5 min
Maximum upper sensory block to ice: questionnaire
Maximum upper sensory block to ice as charted by the nurse in the electronic charting system
Measured: 5 min
Any anesthetic intervention for patchy or asymmetric block
The anesthetic record will be reviewed for any interventions done.
Measured: 5 min
Number of manual epidural top ups
The number of top ups given by nurses or physicians manually will be recorded from the chart.
Measured: 5 min
Number of PCEA (patient controlled epidural analgesia) boluses delivered
Number of PCEA (patient controlled epidural analgesia) boluses delivered will be collected from the chart.
Measured: 5 min
Duration of epidural analgesia
Time of epidural placement to delivery or placement to top up for caesarean delivery.
Measured: 5 min
Quality of analgesia questionnaire - 1st stage
Quality of analgesia during first stage as defined by the patient on a VNRS (verbal numerical rating scale) 0-10 :
On a scale from 0-10 (where 0 is not at all and 10 is the best ever), how well did your epidural work from the start of your epidural until you were fully dilated?
Measured: 5 min
Quality of analgesia questionnaire - 2nd stage
Quality of analgesia during second stage as defined by the patient on a VNRS (verbal numerical rating scale) 0-10:
On a scale from 0-10 (where 0 is not at all and 10 is the best ever), how well did your epidural work from you were fully dilated until the delivery of your baby?
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start17 Nov 2021
- Primary completion6 Jun 2022
- Study completion6 Jun 2022
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 PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose CA Carvalho, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126745
- Sponsor's protocol ID
- 21-07
- Status last verified
- Jul 2022
- First submitted
- 25 Oct 2021
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van den Bosch OFC, Gleicher Y, Arzola C, Siddiqui N, Downey K, Carvalho JCA. Color flow Doppler in spinal ultrasound: a novel technique for assessment of catheter position in labor epidurals. Reg Anesth Pain Med. 2022 Dec;47(12):775-779. doi: 10.1136/rapm-2022-103948. Epub 2022 Sep 7.
PubMed 36215115
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Catheter Flow Direction Using Color Flow Doppler in Labor Epidurals: an Observational Study
- ClinicalTrials.gov ID
- NCT05126745
- Acronym / sponsor ID
- 21-07
- Conditions
- Labor Pain
- Keywords
- epidural catheter, epidural analgesia, labor epidural, ultrasound, Doppler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 19 Nov 2021 (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.
Epidural analgesia is commonly used for pain relief in labor and involves placement of a catheter in the epidural space. Failure of epidural analgesia may occur in 12-16% of epidural catheter placements. It is defined as inadequate analgesia after the local anesthetic loading dose, despite use of appropriate dose/concentration of local anesthetic. Failure to provide adequate epidural analgesia is commonly caused by malposition of the epidural catheter. Many factors may influence the position of the tip of the epidural catheter and the resulting spread of local anesthetic into the epidural space, and consequently the quality of analgesia. Previously, X-ray exposure was required to assess catheter position in the epidural space. Recent developments have allowed the anesthesiologist to assess the catheter position at the bedside after its placement, using color flow Doppler ultrasonography.
The investigators will perform an observational study to determine epidural catheter flow direction in the obstetrical population using color flow Doppler ultrasound. Women who have delivered under epidural analgesia, either vaginal or caesarean delivery, will be approached for the study before the epidural catheter is removed.
The investigators aim to determine epidural flow relative to the insertion site, describe the findings and to correlate them with other clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who had an epidural placed for labour | – | Device: color flow Doppler ultrasonographyPatients who had an epidural placed for labour may take part. Study procedures will take place after delivery and prior to removal of the epidural catheter. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women who have delivered under epidural analgesia, either with vaginal or caesarean delivery, will be approached for the study before the epidural catheter is removed.
Key inclusion criteria (3 listed)
- Women who have delivered under epidural analgesia
- Women who have vaginal or caesarean delivery
- Women with the epidural catheter still in place
Key exclusion criteria (1 listed)
- -Women who experience fetal or maternal complications during delivery
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 |
|---|---|---|
| color flow Doppler ultrasonographyDoppler ultrasonography | Device | Patients who had an epidural placed for labour |
Primary outcome
Visualization of flow relative to the interspace insertion level as assessed by color flow Doppler ultrasound
Time frame: 15 min
Visualization of flow relative to the interspace insertion level as assessed by color flow Doppler ultrasound (at insertion level [yes/no], above insertion level [yes/no], below insertion level [yes/no], no visualization of flow in any space).
9 secondary outcomes
Level of epidural catheter insertion: questionnaire
Time frame: 5 min
Epidural regimen: questionnaire
Time frame: 5 min
Maximum upper sensory block to ice: questionnaire
Time frame: 5 min
Any anesthetic intervention for patchy or asymmetric block
Time frame: 5 min
Number of manual epidural top ups
Time frame: 5 min
Number of PCEA (patient controlled epidural analgesia) boluses delivered
Time frame: 5 min
Duration of epidural analgesia
Time frame: 5 min
Quality of analgesia questionnaire - 1st stage
Time frame: 5 min
Quality of analgesia questionnaire - 2nd stage
Time frame: 5 min
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 29 Jul 2022.
- Derived from this study: PubMed 36215115van den Bosch OFC, Gleicher Y, Arzola C, Siddiqui N, Downey K, Carvalho JCA. Color flow Doppler in spinal ultrasound: a novel technique for assessment of catheter position in labor epidurals. Reg Anesth Pain Med. 2022 Dec;47(12):775-779. doi: 10.1136/rapm-2022-103948. Epub 2022 Sep 7.
- 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.
Jose CA Carvalho, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital 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 3 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 29 Jul 2022. 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?
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?
Visualization of flow relative to the interspace insertion level as assessed by color flow Doppler ultrasound (time frame: 15 min). 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 NCT05126745, 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 29 Jul 2022.