PregnancyNCT02747238
Does Ultrasound Help Junior Anesthesia Residents With Placement of Labor Analgesia in Pregnant Patients
A study testing Ultrasound, No ultrasound and Epidural infusion in people with Pregnancy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The investigators believe that ultrasound guided CSE technique will help junior resident rotating for the first time on the labor and delivery floor to place more accurately the epidural needle in the midline position as compared to placing the epidural needle 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?
- Ultrasound, No ultrasound and Epidural infusion
- 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
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2018to 24 Feb 2020
- 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
- Nulliparous
- 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 Thereby Helping Junior Residents With Correct Placement of the Catheter Compared to the Placement Using With Anatomical Landmarks?
The investigators believe that ultrasound guided CSE technique will help junior resident rotating for the first time on the labor and delivery floor to place more accurately the epidural needle in the midline position as compared to placing the epidural needle via palpation of anatomical landmarks. This will result in increased ability to place the spinal component with positive cerebral spinal fluid (CSF) in the spinal needle, correct midline placement of the epidural catheter, and increase the likelihood of 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.
A previous study done by the research team, comparing "blind" vs US guidance technique. It did not show any significant difference in term of success rate or complications with either technique. However, the study was done by 4 trained physicians with lot of practice. At this level of training, the investigators did not observe any technique improvement with US. Which is why the investigators thought might have more success in showing an improvement in technique, with junior residents rotating for the first time on the floor. The idea is to see if there is any difference in their learning curve using the US versus the "blind" technique. Each resident will be their own control.
- Conditions
- Pregnancy
- Being tested
- Ultrasound, No ultrasound, Epidural infusion
- Keywords
- Pregnancy, Epidural, Labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 ultrasoundProcedure or surgery
Palpation of anatomical landmarks is used for placement of labor analgesia
Epidural infusionProcedure or surgery
An epidural infusion will be started in both groups, regarding of the technique used for placement, and the same solution of Bupivacaine 0.0625% with 2mcg fentanyl/cc will be used in both groups
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Active comparator | Woman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started Receives: Device: Ultrasound; Procedure: Epidural infusion |
| No ultrasound | Active comparator | Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Receives: Procedure: No ultrasound; Procedure: Epidural infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Learning Curve of Anesthesia Residents
The success rate of epidural with each technique and improvement
Measured: 1 month
Secondary outcomes (3)
Number of Attempts
The number of attempts to locate the epidural space and midline position via ultrasound guided CSE technique.
Measured: 30 minutes
Percentage of Accurate Epidural Placement
Percentage of accurate epidural placement assessed by participant reporting pain 2 hours after CSE placed
Measured: 2 hours
Number of Angle Adjustments in Space
The number of angle adjustments of the epidural needle via ultrasound guided CSE technique.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study start29 Jan 2018
- Primary completion24 Feb 2020
- Study completion24 Feb 2020
Why it stopped: lack of enrollment
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.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara S Orlando, Icahn School of Medicine at Mount Sinai
- Investigators
- Barbara Orlando, MD, Principal investigator, Mount-Sinai Roosevelt Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747238
- Sponsor's protocol ID
- GCO 15-1180
- Status last verified
- Mar 2021
- First submitted
- 3 Jun 2015
- Last updated
- 15 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. 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 Thereby Helping Junior Residents With Correct Placement of the Catheter Compared to the Placement Using With Anatomical Landmarks?
- ClinicalTrials.gov ID
- NCT02747238
- Acronym / sponsor ID
- GCO 15-1180
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Epidural, Labor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of enrollment
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Posted 15 Apr 2021
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 help junior resident rotating for the first time on the labor and delivery floor to place more accurately the epidural needle in the midline position as compared to placing the epidural needle via palpation of anatomical landmarks. This will result in increased ability to place the spinal component with positive cerebral spinal fluid (CSF) in the spinal needle, correct midline placement of the epidural catheter, and increase the likelihood of 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.
A previous study done by the research team, comparing "blind" vs US guidance technique. It did not show any significant difference in term of success rate or complications with either technique. However, the study was done by 4 trained physicians with lot of practice. At this level of training, the investigators did not observe any technique improvement with US. Which is why the investigators thought might have more success in showing an improvement in technique, with junior residents rotating for the first time on the floor. The idea is to see if there is any difference in their learning curve using the US versus the "blind" technique. Each resident will be their own control.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Active comparator | Device: Ultrasound, Procedure: Epidural infusionWoman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started |
| No ultrasound | Active comparator | Procedure: No ultrasound, Procedure: Epidural infusionPalpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Nulliparous
- 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 |
|---|---|---|
| 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 | Ultrasound |
| No ultrasoundPalpation of anatomical landmarks is used for placement of labor analgesia | Procedure or surgery | No ultrasound |
| Epidural infusionAn epidural infusion will be started in both groups, regarding of the technique used for placement, and the same solution of Bupivacaine 0.0625% with 2mcg fentanyl/cc will be used in both groups | Procedure or surgery | No ultrasound, Ultrasound |
Primary outcome
Learning Curve of Anesthesia Residents
Time frame: 1 month
The success rate of epidural with each technique and improvement
3 secondary outcomes
Number of Attempts
Time frame: 30 minutes
Percentage of Accurate Epidural Placement
Time frame: 2 hours
Number of Angle Adjustments in Space
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- 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.
Barbara Orlando, 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 Ultrasound, No ultrasound and Epidural infusion in people with Pregnancy, run by Icahn School of Medicine at Mount Sinai 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: stopped early, as of the sponsor's last update on 15 Apr 2021. 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 15 Apr 2021). 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?
Learning Curve of Anesthesia Residents (time frame: 1 month). 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 15 Apr 2021.