PregnancyNCT02207972
Does Ultrasound Help With Placement of Labor Analgesia in Pregnant Patients?
A study testing Use of Ultrasound and No ultrasound used in people with Pregnancy, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
The investigators believe that ultrasound guided CSE technique will accurately place the epidural needle in the midline position compared to epidural needle placement via palpation of anatomical landmarks. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Use of Ultrasound and No ultrasound used
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nulliparious
- Term (>37 weeks gestation)
- Vertex presentation
- Singleton gestation
- Ability to provide informed consent
- Request for analgesia for labor pain
- Maternal age 18 years or greater
Who cannot join
- Multiparous
- Preterm (< 37 weeks gestation)
- Presentation other than vertex (breech, transverse)
- Active drug/alcohol dependence
- Previous spinal surgeries
- Known spinal deformities
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount-Sinai Roosevelt hospital
New York, New York, 10019
About this study
Official title: Does Ultrasound-guided CSE Technique Improve Midline Placement of Epidural Needle With Positive CSF Flow, Thereby Facilitating Correct Placement of the Catheter Compared to Catheter Placement Using Palpation of Anatomical Landmarks?
The investigators believe that ultrasound guided CSE technique will accurately place the epidural needle in the midline position compared to epidural needle placement via palpation of anatomical landmarks. This will result in positive CSF in the spinal needle, correct placement of the catheter, and adequate symmetrical labor analgesia/anesthesia.
Read the detailed description
Epidurals provide superior labor analgesia and anesthesia. Unfortunately, failure of epidural anesthesia and analgesia is a frequent clinical problem. In a heterogeneous cohort of 2,140 surgical patients, a failure rate of 27% for lumbar epidural was described. However, the definition of a failed epidural is broad. Different definitions include insufficient analgesia to catheter dislodgement to conversion to general anesthesia. Epidural analgesia failures may result from technical difficulties, insufficiencies or overdosing of local anesthetics, epidural septum or midline adhesions, and placement of the epidural catheter through an intervertebral foramen or into the anterior epidural space. In an imaging study of failed epidurals, incorrect catheter placement accounted for half of the failures, while the remaining patients experienced suboptimal analgesia through a correctly positioned catheter.
The incidence of overall failure was lower in patients receiving combined spinal-epidural (CSE) catheters versus epidural analgesia. In one study, the CSE technique provided decreased failure rates for labor analgesia and comparable or decreased failure rates for surgical anesthesia, when compared with reported failure rates for epidural anesthesia. It is believed that positive CSF flow in the spinal needle confirms correct epidural needle placement in the epidural space and also confirms the epidural needle to be in the midline position. Placement of the epidural needle in the midline position will minimize the incorrect placement of the catheter to one side, providing a symmetrical analgesia versus unilateral analgesia.
However, the practice of CSE and epidural catheter placement relies on the palpation of anatomical landmarks that are not always easy to feel. Therefore, the epidural needle maybe placed "off midline" despite positive loss of resistance (LOR) that causes negative CSF flow in the spinal needle and an incorrectly placed catheter. As a result, the incorrect catheter placement will result in a "failed" or suboptimal epidural analgesia.
Ultrasound has recently been utilized to facilitate lumbar epidurals and spinals. The US imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia.
- Conditions
- Pregnancy
- Being tested
- Use of Ultrasound, No ultrasound used
- Keywords
- Pregnant, labor, Epidural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of UltrasoundDevice
The ultrasound imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia.
No ultrasound usedProcedure or surgery
Palpation of anatomical landmarks is used for placement of labor analgesia
| Study group | Role | What they receive |
|---|---|---|
| Use of Ultrasound | Active comparator | Woman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml Receives: Device: Use of Ultrasound |
| No ultrasound used | Active comparator | Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml Receives: Procedure: No ultrasound used |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Accurate Epidural Placement
Number of ultrasound guided CSE technique accurately placed epidural needle in the midline position
Measured: 2 hours
Secondary outcomes (2)
Number of Participants With Successful First Attempt
The number of participants who had first attempt success to locate the epidural space and midline position
Measured: Immediate
Number of Participants Without Angle Adjustments in Space Success
the number of participants with successes without any readjustment of the angle in the space
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startMay 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PregnancyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Migdalia Saloum, MD, Principal investigator, Mount Sinai Roosevelt Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207972
- Sponsor's protocol ID
- IRB #12-172
- Status last verified
- Feb 2018
- First submitted
- 31 Jul 2014
- Last updated
- 13 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Ultrasound-guided CSE Technique Improve Midline Placement of Epidural Needle With Positive CSF Flow, Thereby Facilitating Correct Placement of the Catheter Compared to Catheter Placement Using Palpation of Anatomical Landmarks?
- ClinicalTrials.gov ID
- NCT02207972
- Acronym / sponsor ID
- IRB #12-172
- Conditions
- Pregnancy
- Keywords
- Pregnant, labor, Epidural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 4 Aug 2014 (estimated)
- Results
- Posted 13 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators believe that ultrasound guided CSE technique will accurately place the epidural needle in the midline position compared to epidural needle placement via palpation of anatomical landmarks. This will result in positive CSF in the spinal needle, correct placement of the catheter, and adequate symmetrical labor analgesia/anesthesia.
Detailed description
Epidurals provide superior labor analgesia and anesthesia. Unfortunately, failure of epidural anesthesia and analgesia is a frequent clinical problem. In a heterogeneous cohort of 2,140 surgical patients, a failure rate of 27% for lumbar epidural was described. However, the definition of a failed epidural is broad. Different definitions include insufficient analgesia to catheter dislodgement to conversion to general anesthesia. Epidural analgesia failures may result from technical difficulties, insufficiencies or overdosing of local anesthetics, epidural septum or midline adhesions, and placement of the epidural catheter through an intervertebral foramen or into the anterior epidural space. In an imaging study of failed epidurals, incorrect catheter placement accounted for half of the failures, while the remaining patients experienced suboptimal analgesia through a correctly positioned catheter.
The incidence of overall failure was lower in patients receiving combined spinal-epidural (CSE) catheters versus epidural analgesia. In one study, the CSE technique provided decreased failure rates for labor analgesia and comparable or decreased failure rates for surgical anesthesia, when compared with reported failure rates for epidural anesthesia. It is believed that positive CSF flow in the spinal needle confirms correct epidural needle placement in the epidural space and also confirms the epidural needle to be in the midline position. Placement of the epidural needle in the midline position will minimize the incorrect placement of the catheter to one side, providing a symmetrical analgesia versus unilateral analgesia.
However, the practice of CSE and epidural catheter placement relies on the palpation of anatomical landmarks that are not always easy to feel. Therefore, the epidural needle maybe placed "off midline" despite positive loss of resistance (LOR) that causes negative CSF flow in the spinal needle and an incorrectly placed catheter. As a result, the incorrect catheter placement will result in a "failed" or suboptimal epidural analgesia.
Ultrasound has recently been utilized to facilitate lumbar epidurals and spinals. The US imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of Ultrasound | Active comparator | Device: Use of UltrasoundWoman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml |
| No ultrasound used | Active comparator | Procedure: No ultrasound usedPalpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Nulliparious
- Term (>37 weeks gestation)
- Vertex presentation
- Singleton gestation
- Ability to provide informed consent
Key exclusion criteria (6 listed)
- Multiparous
- Preterm (< 37 weeks gestation)
- Presentation other than vertex (breech, transverse)
- Active drug/alcohol dependence
- Previous spinal surgeries
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 |
|---|---|---|
| Use of UltrasoundThe ultrasound imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia. | Device | Use of Ultrasound |
| No ultrasound usedPalpation of anatomical landmarks is used for placement of labor analgesia | Procedure or surgery | No ultrasound used |
Primary outcome
Number of Participants With Accurate Epidural Placement
Time frame: 2 hours
Number of ultrasound guided CSE technique accurately placed epidural needle in the midline position
2 secondary outcomes
Number of Participants With Successful First Attempt
Time frame: Immediate
Number of Participants Without Angle Adjustments in Space Success
Time frame: immediate
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Migdalia Saloum, MD principal investigator
Mount Sinai Roosevelt Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Ultrasound and No ultrasound used in people with Pregnancy, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
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 7 inclusion and 6 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 13 Feb 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 13 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Accurate Epidural Placement (time frame: 2 hours). 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 13 Feb 2018; AzTrials last refreshed its copy on 8 Nov 2026.