Clinical trial NCT01192074: Use of Ultrasound in Obstetric Neuraxial Analgesia and Anesthesia Data Base
Official title: Use of Ultrasound in Obstetric Neuraxial Analgesia and Anesthesia Data Base
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pregnancy
Keywords: Obstetric
Analgesia
Anesthesia
Obstetric Anesthesia
Obstetric Analgesia
ultrasound
ultrasonography
epidural analgesia
epidural anesthesia
spinal anesthesia
neuraxial anesthesia
neuraxial analgesia
pregnancy
labor
cesarean delivery
cesarean section
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2010-08-31
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant patients in labor Pregnant patients scheduled for cesarean section

Brief summary: This is a data base building project on the use of pre-procedure ultrasound for the performance of labor epidural pain relief and spinal anesthesia for cesarean deliveries. Data collection includes ultrasound measured depth, actual needle depth, angle of ultrasound probe, actual needle angle, success rates, patient height and weight, number of attempts needed to place the epidural needle or spinal needle. Currently we are looking at the agreement between ultrasound determined depth of the epidural space or intrathecal space with actual needle depth.

Detailed description: All patients presenting in labor or are having a cesarean delivery are eligible except: patients who are under age 18, have contraindications to regional anesthesia, in advanced labor, having emergency conditions and/or unable to understand the consent process.

* Data collected include:
* Ultrasound depth in transverse and oblique sagittal views
* Actual needle depth
* Level of placement
* Number of separate needle placements
* Number of needle redirects
* Angle of probe
* Angle of needle
* Total number of attempts
* Pt height
* Pt weight
* Pt BMI
* Pt age
* Pt gravity/parity
* Pt co-morbidities, e.g. pre-eclampsia
* Procedure performed
* Operator (Attending, CA-1, CA-2, CA-3, CRNA)

What is currently being examined is the correlation between ultrasound depth of the target area vs actual needle depth

Eligibility criteria: Inclusion Criteria:

* Pregnant women in labor or scheduled for induction requesting labor epidural analgesia
* Pregnant women scheduled for cesarean delivery
* Pregnant women in labor who are going to have a non-emergent cesarean delivery under spinal anesthesia

Exclusion Criteria:

* Emergency delivery
* Emergency cesarean section
* Advanced labor
* Contraindications to neuraxial analgesia/anesthesia
* Unable to understand consent
* Under the age of 18

Primary outcomes:
measure: Correlation of Ultrasound vs Needle Depth
timeFrame: Beginning of ultrasound exam to end of ultrasound exam: average 5 min
Secondary outcomes:
measure: Attempt Number
timeFrame: Beginning of placement of epidural or spinal needle to end of placement: average 10 min
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Women's and Children's Hospital
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Steven T Fogel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carvalho JC. Ultrasound-facilitated epidurals and spinals in obstetrics. Anesthesiol Clin. 2008 Mar;26(1):145-58, vii-viii. doi: 10.1016/j.anclin.2007.11.007.
citation: Arzola C, Davies S, Rofaeel A, Carvalho JC. Ultrasound using the transverse approach to the lumbar spine provides reliable landmarks for labor epidurals. Anesth Analg. 2007 May;104(5):1188-92, tables of contents. doi: 10.1213/01.ane.0000250912.66057.41.
citation: Chin KJ, Perlas A, Singh M, Arzola C, Prasad A, Chan V, Brull R. An ultrasound-assisted approach facilitates spinal anesthesia for total joint arthroplasty. Can J Anaesth. 2009 Sep;56(9):643-50. doi: 10.1007/s12630-009-9132-8. Epub 2009 Jun 23.
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. Ultrasound control for presumed difficult epidural puncture. Acta Anaesthesiol Scand. 2001 Jul;45(6):766-71. doi: 10.1034/j.1399-6576.2001.045006766.x.