Does Ultrasound of the Spine Improve Labor Epidurals/Spinal Anesthesia in Obstetric Patients?
Recruitment status was Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||The Utility of Pre-procedure Ultrasound for Neuraxial Analgesia/Anesthesia in Obstetric Patients|
- Number of attempts needed for proper needle placement [ Time Frame: 30 min or less ] [ Designated as safety issue: No ]An attempt is defined as a separate needle puncture. A needle pass is defined as the passage of a needle through a single puncture site
- Time [ Time Frame: 30 min ] [ Designated as safety issue: No ]The time for performance of an ultrasound exam as well as the time for needle placement for labor epidurals or spinal anesthesia
- Patient Satisfaction [ Time Frame: 30 min ] [ Designated as safety issue: No ]Patients will be given a questionaire grading their satisfaction on a 1 to 5 scale 1-very unsatisfied, 5-very satisfied
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||October 2011|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: Ultrasound Group
Patients in the Ultrasound Group will have a pre-procedure ultrasound of the spine prior to needle placement
Ultrasound examination of the lumbar spine. The level of the lumbar interspace will be determined by the oblique/sagittal method. The transverse method will be used to determine the best lumbar interspace and the distance from the skin to the target (epidural space or intrathecal space)
No Intervention: No Ultrasound Group
Patients in the No Ultrasound Group will not have a pre-procedure ultrasound of the spine performed prior to needle placement.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243216
|Contact: Steven T Fogel, M.D.||firstname.lastname@example.org|
|United States, Missouri|
|Women's and Children's Hospital||Recruiting|
|Columbia, Missouri, United States, 65201|
|Contact: Steven T Fogel, M.D. 573-882-2568 email@example.com|
|Principal Investigator: Steven T Fogel, M.D.|
|Principal Investigator:||Steven T Fogel, M.D.||University of Missouri-Columbia School of Medicine|