About this trial
In this double blinded randomized controlled trial, the investigators would like to compare the effects on needle manipulation when relatively inexperienced sonographist (\< 1 year of ultrasound experience) perform ultrasound guided labor epidurals utilizing a traditional handheld ultrasound versus a handheld device that was engineered to provide automated guidance. The primary outcome of this study would be number of needle passes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
ASA-1, ASA-2, and ASA-3
Patients with no known back deformities
Ability to sit upright for epidural placement
No prior lumbar surgery
Disqualifiers
Coagulopathy
Low platelet count
Allergies to local anesthetics
Trial design
Parallel
Treatments tested in this trial
Traditional ultrasound
DeviceLabor epidural will be performed after marking patient skin using traditional ultrasound guidance
Automated ultrasound
DeviceLabor epidural will be performed after marking patient skin using an automated ultrasound device
Treatment groups
Trial outcomes
Primary outcomes
Number of needle passes
Number of ventral needle movements without removing needle from skin. A needle pass is defined as any forward advancement or withdraw and forward redirection of the needle without withdraw from the skin.
Secondary outcomes
Number of Needle attempts
Number of times the needle is advanced in and out of the skin
Time to obtain ultrasound images with traditional ultrasound device
Time from placing ultrasound on patients back until markings are complete
Time to obtain images with automated ultrasound device
Time from placing ultrasound on patients back until markings are complete
Time from local anesthetic injection till time of epidural space identification
Time will be recorded once local anesthetic is injected and stopped upon obtaining loss of resistance
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: