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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| palpation guidance | Placebo Comparator | placement of spinal or combined spinal epidural needle using palpation to guide entry position |
|
| ultrasound guidance | Active Comparator | placement of spinal or combined spinal epidural using ultrasound to guide entry position |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound guidance | Device | use of ultrasound for entry position estimation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Placement Below L3 Vertebra | Percentage of participants with catheters placed below the L3 Vertebra | immediately post epidural catheter placement |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During the procedure |
| Success of the Epidural Catheter Placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip E Hess, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Isreal Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Palpation Guidance | placement of spinal or combined spinal epidural needle using palpation to guide entry position palpation guidance: use of palpation for position estimation |
| FG001 | Ultrasound Guidance | placement of spinal or combined spinal epidural using ultrasound to guide entry position ultrasound guidance: use of ultrasound for entry position estimation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Palpation Guidance | placement of spinal or combined spinal epidural needle using palpation to guide entry position palpation guidance: use of palpation for position estimation |
| BG001 | Ultrasound Guidance |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Placement Below L3 Vertebra | Percentage of participants with catheters placed below the L3 Vertebra | Posted | Count of Participants | Participants | immediately post epidural catheter placement |
|
1 hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Palpation Guidance | placement of spinal or combined spinal epidural needle using palpation to guide entry position palpation guidance: use of palpation for position estimation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Compliance | BIDMC | 617-667-1897 | BILH-researchcompliance@bilh.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 8, 2014 | Feb 11, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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randomized blinded comparison of two methods to identify landmarks for a procedure
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| palpation guidance |
| Device |
use of palpation for position estimation |
|
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 |
| immediately post epidural catheter placement up to 30 minutes |
placement of spinal or combined spinal epidural using ultrasound to guide entry position
ultrasound guidance: use of ultrasound for entry position estimation
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Nulliparity | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | seconds | During the procedure |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | immediately post epidural catheter placement up to 30 minutes |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Ultrasound Guidance | placement of spinal or combined spinal epidural using ultrasound to guide entry position ultrasound guidance: use of ultrasound for entry position estimation | 0 | 49 | 0 | 49 | 0 | 49 |
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