Clinical trial NCT01243216: Does Ultrasound of the Spine Improve Labor Epidurals/Spinal Anesthesia in Obstetric Patients?
Official title: The Utility of Pre-procedure Ultrasound for Neuraxial Analgesia/Anesthesia in Obstetric Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pregnancy
Labor Pain
Keywords: Pregnancy
Labor
Epidural Analgesia
Epidural Anesthesia
Spinal Anesthesia
Ultrasound
Neuraxial Analgesia
Neuraxial Anesthesia
Cesarean delivery
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2010-11-18
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators are interested in determining the utility of ultrasound of the spine for labor epidurals or spinal anesthesia for women in labor or having a cesarean delivery. The investigators hypothesized that in women with poor spinal landmarks that the use of ultrasound of the spine will improve the process of placing labor epidurals or spinal anesthetics

Detailed description: Ultrasound has been in use for peripheral regional anesthesia for several years and is becoming more common. It is currently routinely used here at the University of Missouri. Ultrasound for neuraxial anesthesia, however, is less common and is only being done in a few centers.. There have been several case reports of its use in obstetric anesthesia for patients with prior spinal surgery or spinal deformity. There have been even few prospective randomized studies. While its use may have significant advantages, it is not yet clear what those advantages are and in whom it may be most beneficial. The investigators seek to answer the following questions regarding the use of preprocedure ultrasound for neuraxial analgesia/anesthesia in obstetric patients:

* Are there benefits to the use of pre procedure ultrasound for neuraxial analgesia/anesthesia?
* If so, what are the benefits?
* If measurable, to what extent does the patient benefit?
* Do all patients benefit or only a specific subgroup?
* Is there a "cost" to the use of pre procedure ultrasound, i.e. extra time needed to perform the ultrasound exam vs a "savings" with the use of pre procedure ultrasound, i.e., less time to perform the epidural analgesic or spinal anesthetic as a direct result of the use of ultrasound?
* In particular the investigators hypothesize that in patients whose spinal landmarks are not palpable or are barely palpable, ultrasound will be found to be beneficial as determined by metrics described below (see item #6). In patients whose landmarks are prominent or easily palpable pre procedure ultrasound will not be of significant benefit.

Eligibility criteria: Inclusion Criteria:

* Women in labor
* Women scheduled for cesarean delivery

Exclusion Criteria:

* Under age 18
* Emergency cesarean deliveries
* Unable to cooperate with ultrasound examination or regional anesthesia
* Advanced labor
* Contraindications to regional anesthesia
* Unable to understand the consent process

Primary outcomes:
measure: Number of attempts needed for proper needle placement
timeFrame: 30 min or less
Secondary outcomes:
measure: Time
timeFrame: 30 min
measure: Patient Satisfaction
timeFrame: 30 min
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Women's and Children's Hospital
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia School of Medicine
name: Steven T Fogel, M.D.
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.