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.
Patient will be approached upon admission to labor and delivery floor (Standard of care). The study will be presented to the patient and if they agree, they will be consented. (Study). Upon epidural patient request patient will be randomized to A-US vs B-US based on the randomization table. Ten envelopes will be available with the randomization choice. (Study). The resident will walk in with both US devices into the room (for patient blinding) and perform scan with the device the randomization table called for. (Study). After performing scan and markings of the patients back, the research fellow or clinical fellow will be called into the room to evaluate the number of needle manipulation and provide surveys related to patient and labor analgesia satisfaction. (Study). Number of needle insertion attempts: defined as advancement of the needle through the skin in an effort to enter the epidural space; a needle requiring withdrawal from the skin for reinsertion is to be counted as an additional insertion attempt. Time to landmark identification: defined as the time interval between the start of needle puncture site identification and the time to first needle puncture attempt. The start time of needle puncture site identification in both the LT and UST corresponds to when the resident physician first places his/her hand on the patient to palpate the back. In both groups, all materials, supplies, and equipment will be prepared and readily available prior to the start of the procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
200
Labor epidural will be performed after marking patient skin using traditional ultrasound guidance
Labor epidural will be performed after marking patient skin using an automated ultrasound device
Yale University
New Haven, Connecticut, United States
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.
Time frame: From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes
Number of Needle attempts
Number of times the needle is advanced in and out of the skin
Time frame: From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes
Time to obtain ultrasound images with traditional ultrasound device
Time from placing ultrasound on patients back until markings are complete
Time frame: Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes
Time to obtain images with automated ultrasound device
Time from placing ultrasound on patients back until markings are complete
Time frame: Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes
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
Time frame: Up to 60 minutes
Accuracy of handheld ultrasound - difference between predicted epidural space distance minus actual needle distance
Accuracy will equal the difference between the estimated depth calculated by the device - actual needle depth as measured from skin to epidural space in centimeters.
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Time frame: Up to 60 minutes
Accuracy of automated ultrasound device - difference between predicted epidural space distance minus actual needle distance
Accuracy will equal the difference between the estimated depth calculated by the device - actual needle depth as measured from skin to epidural space in centimeters.
Time frame: Up to 60 minutes
Patient satisfaction
Assessed after the administration of the loading dose. Patient will be asked to rate their pain on a scale 0-10, 0 = not satisfied, 10 = completely satisfied
Time frame: 15 - 20 minutes after epidural placement