An interventional study of ultrasound guidance and palpation guidance in Labor Pain, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Treatment
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. 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?
This study contains two phases:
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.
396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.
This study's enrollment of 110 is close to the median of 100 across 326 interventional studies indexed under Labor Pain.
Browse Labor Pain studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
placement of spinal or combined spinal epidural needle using palpation to guide entry position
Device: palpation guidance
placement of spinal or combined spinal epidural using ultrasound to guide entry position
Device: ultrasound guidance
use of ultrasound for entry position estimation
use of palpation for position estimation
Placement Below L3 Vertebra
Percentage of participants with catheters placed below the L3 Vertebra
Time frame: immediately post epidural catheter placement
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
Time frame: 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
Time frame: immediately post epidural catheter placement up to 30 minutes
| Milestone | Palpation Guidance | Ultrasound Guidance |
|---|---|---|
| Started | 55 | 55 |
| Completed | 51 | 49 |
| Not completed | 4 | 6 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Physician decision | 2 | 4 |
Percentage of participants with catheters placed below the L3 Vertebra
| Participants | Palpation Guidance | Ultrasound Guidance |
|---|---|---|
| Placement Below L3 Vertebra | 49 | 49 |
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
| seconds | Palpation Guidance | Ultrasound Guidance |
|---|---|---|
| Time to Placement | 173 ± 185 | 162 ± 121 |
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
| Participants | Palpation Guidance | Ultrasound Guidance |
|---|---|---|
| Success of the Epidural Catheter Placement | 51 | 49 |
Collected over 1 hour. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Palpation Guidance | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
| Ultrasound Guidance | 0/49 (0%) | 0/49 (0%) | 0/49 (0%) |
| Age, Continuous(years) | Palpation Guidance | Ultrasound Guidance | Total |
|---|---|---|---|
| Mean | 33.7 ± 5.2 | 33.3 ± 4.9 | 33.5 ± 5.0 |
| Sex: Female, Male(Participants) | Palpation Guidance | Ultrasound Guidance | Total |
|---|---|---|---|
| Female | 51 | 49 | 100 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Palpation Guidance | Ultrasound Guidance | Total |
|---|---|---|---|
| Hispanic or Latino | 8 | 6 | 14 |
| Not Hispanic or Latino | 43 | 43 | 86 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Palpation Guidance | Ultrasound Guidance | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 7 | 9 | 16 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 10 | 14 | 24 |
| White | 34 | 26 | 60 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Nulliparity(Participants) | Palpation Guidance | Ultrasound Guidance | Total |
|---|---|---|---|
| Count of participants | 29 | 27 | 56 |
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Beth Israel Deaconess Medical Center