An interventional study of Ultrasound and Palpation in Labor Pain, sponsored by Thomas J. Vernon. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-11.
Sponsored by Thomas J. Vernon · Not applicable, Interventional, and Treatment
Placement of labor epidurals is a very common daily practice in obstetrical anesthesia. Currently, these epidurals are placed based upon palpation of landmarks to determine midline and the correct spinal level for placement. Palpation of these landmarks can be difficult, however, particularly in morbidly obese patients who have significant amounts of soft tissue overlying them. This study seeks to use ultrasound guidance to examine the spine prior to epidural placement, and see what effects this has compared to palpation alone with respect to procedure time, number of attempts, success rate in the first attempt, failure rate, complication rate, patient anxiety levels, and patient satisfaction levels.
396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.
This study's enrollment of 18 is below the median of 100 across 326 interventional studies indexed under Labor Pain.
Browse Labor Pain studies →This is the only study on the registry with Thomas J. Vernon as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
Device: Ultrasound
The control group that will have their epidural placed in the usual fashion based on palpation
Other: Palpation
Using ultrasound guidance to evaluate the spine prior to epidural placement
Using palpation only to evaluate the spine prior to epidural placement
Total Time Required for Epidural Catheter Placement
Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter
Time frame: Assessed immediately during epidural catheter placement
Epidural Procedure Time
Time required to successfully place the epidural catheter
Time frame: Assessed immediately during epidural catheter placement
Number of Attempts at Epidural Catheter Placement
Time frame: Assessed immediately during epidural catheter placement
Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt
Time frame: Assessed immediately during epidural catheter placement
Complications
Any epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported.
Time frame: Assessed immediately during epidural catheter placement and within 24 hours after delivery
Epidural Failure Rate
Any epidural catheter that fails to provide appropriate analgesia requiring them to be replaced with a new epidural catheter will be documented and reported
Time frame: Assessed within 24 hours after delivery
Epidural Catheter Placement Satisfaction Level
Immediately following epidural catheter placement, patients will be asked to rate their satisfaction level during the procedure on a 0-10 scale, with 0 being not at all satisfied, and 10 being extremely satisfied.
Time frame: Assessed immediately following epidural catheter placement
Patient Anxiety Level
Immediately following epidural catheter placement, patients will be asked to rate their anxiety level during the procedure on a 0-10 scale, where 0 is no anxiety at all, and 10 is the worst anxiety imaginable.
Time frame: Assessed immediately following epidural catheter placement
Palpation or Ultrasound Time
The time taken to evaluate the spine, either by palpation or ultrasound guidance, and mark the location for epidural catheter insertion
Time frame: Assessed immediately prior to epidural catheter placement
Overall Anesthesia Experience Satisfaction
Within 24 hours after delivery, patients will be given a 13 question survey. The survey is a modified Woman's Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) which asks patients to rate 13 various satisfaction related statements on a 1-7 scale, with 1 being totally disagree, 4 being neither agree nor disagree, and 7 being totally agree. Each of the 13 questions asked are designed to assess their overall satisfaction with their epidural catheter placement and overall anesthesia care. The total score is reported combining all 13 questions for a possible score range of 13-91. A higher total score indicates a higher overall anesthesia experience satisfaction level. No subscales were used.
Time frame: Measured within 24 hours of delivery
| Milestone | Ultrasound Group | Palpation Group |
|---|---|---|
| Started | 8 | 10 |
| Completed | 7 | 9 |
| Not completed | 1 | 1 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 |
Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter
| Minutes | Ultrasound Group | Palpation Group |
|---|---|---|
| Total Time Required for Epidural Catheter Placement | 6.1 ± 3.5 | 11.0 ± 5.3 |
Time required to successfully place the epidural catheter
| Minutes | Ultrasound Group | Palpation Group |
|---|---|---|
| Epidural Procedure Time | 4.33 ± 3.5 | 10.1 ± 5.4 |
| Number of attempts | Ultrasound Group | Palpation Group |
|---|---|---|
| Number of Attempts at Epidural Catheter Placement | 1 (1 to 1) | 5 (3 to 5) |
| Participants | Ultrasound Group | Palpation Group |
|---|---|---|
| Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt | 5 | 2 |
Any epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported.
| Complications | Ultrasound Group | Palpation Group |
|---|---|---|
| Complications | 0 | 4 |
Any epidural catheter that fails to provide appropriate analgesia requiring them to be replaced with a new epidural catheter will be documented and reported
| Participants | Ultrasound Group | Palpation Group |
|---|---|---|
| Epidural Failure Rate | 0 | 0 |
Immediately following epidural catheter placement, patients will be asked to rate their satisfaction level during the procedure on a 0-10 scale, with 0 being not at all satisfied, and 10 being extremely satisfied.
| Units on a scale | Ultrasound Group | Palpation Group |
|---|---|---|
| Epidural Catheter Placement Satisfaction Level | 9 ± 1.2 | 7.3 ± 2.8 |
Immediately following epidural catheter placement, patients will be asked to rate their anxiety level during the procedure on a 0-10 scale, where 0 is no anxiety at all, and 10 is the worst anxiety imaginable.
| Units on a scale | Ultrasound Group | Palpation Group |
|---|---|---|
| Patient Anxiety Level | 5.4 ± 1.9 | 6.0 ± 2.6 |
The time taken to evaluate the spine, either by palpation or ultrasound guidance, and mark the location for epidural catheter insertion
| Minutes | Ultrasound Group | Palpation Group |
|---|---|---|
| Palpation or Ultrasound Time | 1.8 ± 0.6 | 0.9 ± 0.1 |
Within 24 hours after delivery, patients will be given a 13 question survey. The survey is a modified Woman's Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) which asks patients to rate 13 various satisfaction related statements on a 1-7 scale, with 1 being totally disagree, 4 being neither agree nor disagree, and 7 being totally agree. Each of the 13 questions asked are designed to assess their overall satisfaction with their epidural catheter placement and overall anesthesia care. The total score is reported combining all 13 questions for a possible score range of 13-91. A higher total score indicates a higher overall anesthesia experience satisfaction level. No subscales were used.
| Units on a scale | Ultrasound Group | Palpation Group |
|---|---|---|
| Overall Anesthesia Experience Satisfaction | 79.1 ± 11.8 | 74.3 ± 9.4 |
Collected over During the patients current hospitalization (typically 2-3 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ultrasound Group | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Palpation Group | 0/9 (0%) | 0/9 (0%) | 3/9 (33.3%) |
| Event | Ultrasound Group | Palpation Group |
|---|---|---|
| ParesthesiaInjury, poisoning and procedural complications | 0/7 | 2/9 |
| Inadvertent dural punctureInjury, poisoning and procedural complications | 0/7 | 1/9 |
Ultrasound 43.75% (7/16); Palpation 56.25% (9/16)
| Age, Continuous(years) | Ultrasound Group | Palpation Group | Total |
|---|---|---|---|
| Mean | 25.3 ± 4.7 | 29.9 ± 5.5 | 27.9 ± 5.4 |
| Sex: Female, Male(Participants) | Ultrasound Group | Palpation Group | Total |
|---|---|---|---|
| Female | 7 | 9 | 16 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Ultrasound Group | Palpation Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 6 | 8 | 14 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Gravidity(Number of pregnancies) | Ultrasound Group | Palpation Group | Total |
|---|---|---|---|
| Median | 1 (1 to 2) | 2 (1 to 3) | 2 (1 to 3) |
| Parity(Number of children born) | Ultrasound Group | Palpation Group | Total |
|---|---|---|---|
| Median | 0 (0 to 1) | 0 (0 to 1) | 0 (0 to 1) |
| Estimated gestational age(Weeks) | Ultrasound Group | Palpation Group | Total |
|---|---|---|---|
| Mean | 39.6 ± 0.8 | 38.1 ± 1.1 | 38.7 ± 1.1 |
| Weight(kg) | Ultrasound Group | Palpation Group | Total |
|---|---|---|---|
| Mean | 122.0 ± 17.1 | 120.6 ± 15.8 | 121.2 ± 15.8 |
| Height(cm) | Ultrasound Group | Palpation Group | Total |
|---|---|---|---|
| Mean | 163.7 ± 5.3 | 162.1 ± 5.3 | 162.8 ± 5.2 |
4 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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