Clinical trial NCT02392533: Ultrasound and Neuraxial Anesthesia in Pregnancy
Official title: Ultrasound Confirmation of Neuraxial Anesthetic Vertebral Level in Post-partum Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infusion Site Anaesthesia
Keywords: ultrasound
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-partum patients who had neuraxial anesthesia for their delivery.

Brief summary: Ultrasonography is routinely performed during pregnancy by obstetricians to visualize the fetus, making patients familiar and comfortable with its usage. Ultrasonography does not result in adverse effects to the mother or fetus and is readily available at most facilities, yet is not routinely used to identify lumbar interspaces prior to providing neuraxial anesthesia. Ultrasonography is a valuable tool for accurately identifying lumbar intervertebral spaces and is more accurate than simple palpation of obscure anatomic landmarks. The investigators are interested to know the accuracy of anatomic landmark palpation in predicting the lumbar interspace of neuraxial anesthesia administration compared to identification of the interspace by ultrasound. The investigators are also interested in presenting anesthesia providers with feedback regarding their accuracy and then investigating whether this feedback causes a change in provider practice (i.e. use of ultrasound) or improved identification of the interspace prior to providing neuraxial anesthesia.

Detailed description: Informed consent will be obtained and documented. All post-partum patients who received neuraxial anesthesia will be asked to provide consent for ultrasound to be used at their bedside to identify the interspace where the neuraxial anesthetic was administered. A low frequency ultrasound probe and sterile gel will be used to perform the less than five-minute study. The site of the neuraxial anesthetic placement will be identified by the puncture mark on the skin. The investigators will note the patient's medical record number and BMI, the names of the resident and attending anesthesiologist who placed the neuraxial anesthetic, the documented intervertebral space at the time of neuraxial anesthetic placement, anesthetic type, whether ultrasound was used for the initial neuraxial placement, and the documented intervertebral space identified post-partum by ultrasound.

Following 3 months of data collection, information regarding the documented intervertebral space versus the actual intervertebral space that the neuraxial anesthetic was administered will be provided to each anesthesiologist and resident. Following delivery of this information, an additional 3 months of data collection will be performed (the same as the first 3 months) to evaluate whether a practice change took place.

Eligibility criteria: Inclusion Criteria: All post-partum patients \> 18 years old who had neuraxial anesthesia for delivery and are English Speaking.

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Exclusion Criteria: Age \< 18 years and non-English speaking, and did not have neuraxial anesthesia for delivery.

Primary outcomes:
measure: Ultrasound identification of lumbar interspace
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago MEDICINE
state: Illinois
Study officials:
affiliation: The University of Chicago MEDICINE
name: Barbara Scavone, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wallace DH, Currie JM, Gilstrap LC, Santos R. Indirect sonographic guidance for epidural anesthesia in obese pregnant patients. Reg Anesth. 1992 Jul-Aug;17(4):233-6.
citation: Grau T, Bartusseck E, Conradi R, Martin E, Motsch J. Ultrasound imaging improves learning curves in obstetric epidural anesthesia: a preliminary study. Can J Anaesth. 2003 Dec;50(10):1047-50. doi: 10.1007/BF03018371.
citation: Grau T, Leipold RW, Conradi R, Martin E, Motsch J. Efficacy of ultrasound imaging in obstetric epidural anesthesia. J Clin Anesth. 2002 May;14(3):169-75. doi: 10.1016/s0952-8180(01)00378-6.
citation: Broadbent CR, Maxwell WB, Ferrie R, Wilson DJ, Gawne-Cain M, Russell R. Ability of anaesthetists to identify a marked lumbar interspace. Anaesthesia. 2000 Nov;55(11):1122-6. doi: 10.1046/j.1365-2044.2000.01547-4.x.