Influence of Lumbar Ultrasound on Resident Learning Curve for Lateral Labor Epidural Placement (NCT02826668) | Clinical Trial Compass
TerminatedNot Applicable
Influence of Lumbar Ultrasound on Resident Learning Curve for Lateral Labor Epidural Placement
Stopped: The study was terminated due to loss of study staff and inability to recruit patients during COVID 19
United States28 participantsStarted 2014-06
Plain-language summary
The aim of this study is to evaluate the impact of lumbar spine ultrasound on the success rate and efficiency of labor epidural placement in the lateral position. The investigators hypothesize that ultrasound imaging of the lumbar spine of women in early labor will yield similar ultrasound results when done immediately prior to epidural placement. The investigators also hypothesize that the use of ultrasound with landmarks marked and depth to the epidural space estimated will facilitate epidural placement in terms of both efficiency (time required for placement) and efficacy of pain relief.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Pregnant Subjects
Inclusion Criteria:
* pregnant women
* 18 years or older
* in early labor (cervix dilated \< 5 cm
* pain visual analog score (VAS) \< 3, or both) requesting consultation by the anesthesia team for anticipated epidural pain relief.
Exclusion Criteria:
* absolute contraindications of neuraxial anesthesia including patient refusal
* uncorrected coagulopathy
* infection at the skin site of epidural placement
* increased intracranial pressure, or untreated hemodynamic instability.
* In addition, patients with a history of scoliosis or spine surgery
* body mass index (BMI) \>40 kg/m2
* allergy to local anesthetic, or allergy to opioids will be excluded.
Anesthesiologists
Inclusion criteria:
* Anesthesia residents or fellows who are performing the epidural technique in pregnant subjects who agree to be part of the study.
* Anesthesia residents or fellows with prior experience in the lumbar epidural technique, defined as having placed 20 or greater lumbar epidurals during their residency and prior to enrollment.
Exclusion criteria:
* individuals who do not want to participate in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Depth to the epidural space (cm) from baseline ultrasound compared to pre-placement ultrasound.
Timeframe: From enrollment to time of epidural placement, approximately 5 hours
2
Time required for epidural placement
Timeframe: From enrollment to time of epidural placement, approximately 5 hours
3
Need for assistance from additional anesthesiologist
Timeframe: From enrollment to time of epidural placement, approximately 5 hours
4
Number of attempts at epidural placement
Timeframe: From enrollment to time of epidural placement, approximately 5 hours
5
Incidence of paresthesias
Timeframe: From enrollment to time of epidural placement, approximately 5 hours
6
Labor pain at time of 30 minutes after placement is complete.
Timeframe: From enrollment to time of epidural placement, approximately 5 hours, plus 30 minutes.