Labor PainNCT02271100
Assessment of the Use of Ultrasound for Epidural Catheter Placement and Comparison With Palpation Technique
A study testing ultrasound guidance and palpation guidance in people with Labor Pain, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This study is intended to determine whether ultrasound imaging can improve the ability to place a spinal or epidural needle in obstetric anesthesia. By evaluating the use of ultrasound for the placement of epidural catheters the investigators hope to answer two questions: 1. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- ultrasound guidance and palpation guidance
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2016to 1 Jan 2025
- 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 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy ASA I or II parturient
- Will be receiving neuraxial placement for labor, having been consented for the procedure
Who cannot join
- ASA III or IV
- Unable to participate in the study due to severe pain
- Contraindications to neuraxial analgesia
- Previous spinal surgery in the lumbar or sacral area (L1 through Sacrum)
- BMI greater than 37
- Height less than 60 inches
- Significant scoliosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
This study is intended to determine whether ultrasound imaging can improve the ability to place a spinal or epidural needle in obstetric anesthesia. By evaluating the use of ultrasound for the placement of epidural catheters the investigators hope to answer two questions:
- How does the traditional technique based on palpation compare to one using ultrasound to place an epidural catheter? 2. Does ultrasound reduce one potential risk in epidural placement?
Read the detailed description
This study contains two phases:
- A prospective, randomized, blinded comparison of ultrasound imaging versus palpation for epidural catheter insertion in laboring women.
- A prospective, single cohort, blinded trial to assess whether ultrasound imaging provides a reliable placement below the L3 vertebra.
The initial phase of the investigation will be a randomized comparison of ultrasound versus palpation. Patients will be enrolled in early labor and will be randomized to have their epidural placed with either technique. The technique will be chosen by computer-generated randomization list maintained in opaque sequentially numbered envelopes. Description of the placement technique is below. The primary outcome will be the number of epidural catheters inserted above the intended insertion site. The investigators will also assess the total time required for epidural catheter placement, number of attempts for successful insertion, effectiveness of the epidural catheter for labor pain control.
Following completion of enrollment of the first phase, the second phase of the investigation will enroll patients only into the single-cohort ultrasound arm. The study will use the same methodology as the initial phase, but without randomization due to a single cohort. The primary outcome will be the absolute number of epidural catheters inserted above the L3 vertebral body. The investigators will also assess the effectiveness of the ultrasound markings for guiding placement.
Procedure placement technique After written, informed consent, and standard patient preparation, the epidural catheter will be placed with the patient in the sitting position by a junior resident. In the ultrasound arm, the patient will be first imaged using an appropriate probe, and the identified ultrasound landmarks marked on the skin. The skin will be prepped in the usual fashion, and the needle will be inserted at the identified site and direction determined by ultrasound. In the palpation arm, the skin will be prepped and the needle will be inserted using palpation-identified landmarks to guide the needle. All catheters will be intended to be placed at the L4-L5 interspace as the primary attempt. The L3-L4 interspace will be used as a secondary attempt.
Assessment of final position After insertion of the epidural catheter and administration of the pain relief medication, patients in both groups will be examined by a blinded observer using ultrasound to determine the catheter insertion site and the likely insertion interspace.
If, however, the investigators discover that the use of ultrasound for placement of the epidural catheter may present greater risk than previously anticipated to the pregnant woman or fetus, then the investigators will stop the study after phase 1 and not proceed with phase 2.
- Conditions
- Labor Pain
- Being tested
- ultrasound guidance, palpation guidance
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guidanceDevice
use of ultrasound for entry position estimation
palpation guidanceDevice
use of palpation for position estimation
| Study group | Role | What they receive |
|---|---|---|
| palpation guidance | Placebo comparator | placement of spinal or combined spinal epidural needle using palpation to guide entry position Receives: Device: palpation guidance |
| ultrasound guidance | Active comparator | placement of spinal or combined spinal epidural using ultrasound to guide entry position Receives: Device: ultrasound guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placement Below L3 Vertebra
Percentage of participants with catheters placed below the L3 Vertebra
Measured: immediately post epidural catheter placement
Secondary outcomes (2)
Time to Placement
The time in minutes for completion of the procedure measured from the start of the procedure defined as administration of the first medication until the epidural test dose was administered
Measured: During the procedure
Success of the Epidural Catheter Placement
Relief of labor pain defined by verbal pain score less than 4 after administration of medication; verbal pain score consisted of a scale from 0 to 10 with 0 representing no pain and 10 representing worst possible pain, with higher numbers representing greater pain felt by the patient
Measured: immediately post epidural catheter placement up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study start25 Oct 2016
- Primary completion31 Dec 2018
- Study completion1 Jan 2025
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 Labor PainStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized blinded comparison of two methods to identify landmarks for a procedure
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phillip Hess, Beth Israel Deaconess Medical Center
- Investigators
- Philip E Hess, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271100
- Sponsor's protocol ID
- 2014P000267
- Status last verified
- Mar 2026
- First submitted
- 17 Oct 2014
- Last updated
- 3 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Use of Ultrasound for Epidural Catheter Placement and Comparison With Palpation Technique
- ClinicalTrials.gov ID
- NCT02271100
- Acronym / sponsor ID
- 2014P000267
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 25 Oct 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Posted 3 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to determine whether ultrasound imaging can improve the ability to place a spinal or epidural needle in obstetric anesthesia. By evaluating the use of ultrasound for the placement of epidural catheters the investigators hope to answer two questions:
- How does the traditional technique based on palpation compare to one using ultrasound to place an epidural catheter? 2. Does ultrasound reduce one potential risk in epidural placement?
Detailed description
This study contains two phases:
- A prospective, randomized, blinded comparison of ultrasound imaging versus palpation for epidural catheter insertion in laboring women.
- A prospective, single cohort, blinded trial to assess whether ultrasound imaging provides a reliable placement below the L3 vertebra.
The initial phase of the investigation will be a randomized comparison of ultrasound versus palpation. Patients will be enrolled in early labor and will be randomized to have their epidural placed with either technique. The technique will be chosen by computer-generated randomization list maintained in opaque sequentially numbered envelopes. Description of the placement technique is below. The primary outcome will be the number of epidural catheters inserted above the intended insertion site. The investigators will also assess the total time required for epidural catheter placement, number of attempts for successful insertion, effectiveness of the epidural catheter for labor pain control.
Following completion of enrollment of the first phase, the second phase of the investigation will enroll patients only into the single-cohort ultrasound arm. The study will use the same methodology as the initial phase, but without randomization due to a single cohort. The primary outcome will be the absolute number of epidural catheters inserted above the L3 vertebral body. The investigators will also assess the effectiveness of the ultrasound markings for guiding placement.
Procedure placement technique After written, informed consent, and standard patient preparation, the epidural catheter will be placed with the patient in the sitting position by a junior resident. In the ultrasound arm, the patient will be first imaged using an appropriate probe, and the identified ultrasound landmarks marked on the skin. The skin will be prepped in the usual fashion, and the needle will be inserted at the identified site and direction determined by ultrasound. In the palpation arm, the skin will be prepped and the needle will be inserted using palpation-identified landmarks to guide the needle. All catheters will be intended to be placed at the L4-L5 interspace as the primary attempt. The L3-L4 interspace will be used as a secondary attempt.
Assessment of final position After insertion of the epidural catheter and administration of the pain relief medication, patients in both groups will be examined by a blinded observer using ultrasound to determine the catheter insertion site and the likely insertion interspace.
If, however, the investigators discover that the use of ultrasound for placement of the epidural catheter may present greater risk than previously anticipated to the pregnant woman or fetus, then the investigators will stop the study after phase 1 and not proceed with phase 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized blinded comparison of two methods to identify landmarks for a procedure
| Arm | Type | Receives |
|---|---|---|
| palpation guidance | Placebo comparator | Device: palpation guidanceplacement of spinal or combined spinal epidural needle using palpation to guide entry position |
| ultrasound guidance | Active comparator | Device: ultrasound guidanceplacement of spinal or combined spinal epidural using ultrasound to guide entry position |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy ASA I or II parturient
- Will be receiving neuraxial placement for labor, having been consented for the procedure
Key exclusion criteria (7 listed)
- ASA III or IV
- Unable to participate in the study due to severe pain
- Contraindications to neuraxial analgesia
- Previous spinal surgery in the lumbar or sacral area (L1 through Sacrum)
- BMI greater than 37
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 |
|---|---|---|
| ultrasound guidanceuse of ultrasound for entry position estimation | Device | ultrasound guidance |
| palpation guidanceuse of palpation for position estimation | Device | palpation guidance |
Primary outcome
Placement Below L3 Vertebra
Time frame: immediately post epidural catheter placement
Percentage of participants with catheters placed below the L3 Vertebra
2 secondary outcomes
Time to Placement
Time frame: During the procedure
Success of the Epidural Catheter Placement
Time frame: immediately post epidural catheter placement up to 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Philip E Hess, MD principal investigator
Beth Israel Deaconess Medical Center
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 guidance and palpation guidance in people with Labor Pain, run by Beth Israel Deaconess Medical 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 2 inclusion and 7 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 3 Mar 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 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. Some participants in this study may receive a placebo. 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 3 Mar 2026). 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?
Placement Below L3 Vertebra (time frame: immediately post epidural catheter placement). 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 3 Mar 2026.