Lumbar Spine Ultrasound of Patients With Previous Accidental Dural Puncture During Labour Epidural
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|ClinicalTrials.gov Identifier: NCT00465166|
Recruitment Status : Completed
First Posted : April 24, 2007
Last Update Posted : December 17, 2007
|First Submitted Date||April 23, 2007|
|First Posted Date||April 24, 2007|
|Last Update Posted Date||December 17, 2007|
|Study Start Date||February 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Lumbar Spine Ultrasound of Patients With Previous Accidental Dural Puncture During Labour Epidural|
|Official Title||Lumbar Spine Ultrasound of Patients With Previous Accidental Dural Puncture During Labour Epidural|
|Brief Summary||Accidental dural puncture is a potential complication of epidural analgesia for labour and delivery. When it happens, it may cause debilitating headaches and other symptoms that prevent mothers from talking care of their newborns. Accidental dural puncture is related to the operator performance and to individual anatomical variations of the spine. The purpose of this study is to do a lumbar spine ultrasound on the patients who have had accidental dural punctures and analyze if there is any abnormal anatomy seen. Then, we will compare the position of any spinal abnormality to the position of the dural puncture reported in the anaesthesia record.|
Effective epidural analgesia depends on accurate identification of the epidural space for delivery of analgesic mixtures. The technique of loss of resistance to either saline or air is the most commonly used method to locate the epidural space. Although this technique has a high success rate, it is associated with a significant incidence of accidental dural punctures. Accidental dural punctures might be related to the operator performance or to individual anatomical variations.
A normal ligamentum flavum is fundamental in the loss of resistance technique. However, many cadaver dissection and radiological studies in the literature have showed that the ligamentum flavum may in fact not fuse at the midline; thereby leaving a gap between its left and right portions. Ligamentum flavum midline gaps are thought to be a potential cause of failed recognition of loss of resistance during epidural needle placement and consequently accidental dural puncture. Therefore, if it were feasible to avoid inserting the epidural needle at the same level where a ligamentum flavum midline gap exists, then dural punctures may be less likely.
Lumbar spine ultrasound has been very useful in consistently identifying important anatomical landmarks for epidural needle placement including the ligamentum flavum. It is unknown at this time whether ultrasound is a useful modality to detect abnormal anatomy. Our study will evaluate by ultrasound scan the lumbar vertebral column of patients who have had a previously recognized accidental dural puncture. Our objective is to determine whether or not there is a correlation between accidental dural punctures and abnormalities of ligamentum flavum as seen by ultrasound imaging. Our hypothesis is that patients who have had accidental dural punctures have abnormal anatomy of ligamentum flavum that can be detected by lumbar spine ultrasound.
Lumbar ultrasound imaging from L1-S1 will be performed with the patient in the sitting position. The best possible image captured at the transverse approach for each of the interspaces from L5-S1 to L1-L2 will be saved for analysis of both ligamentum flavum (primary outcome) and symmetry (secondary outcome). A normal ligamentum flavum is described as a hyperechoic continuous midline band, which is aligned with the hyperechoic signal of the transverse processes. An abnormal ligamentum flavum will be described as a non-continuous or even absent signal. The presence of symmetric anatomy is defined as an equal distant between the left and right articular processes and the transverse processes to the midline.
Incidence of abnormal ligamentum flavum and asymmetry will be presented in a descriptive way and the level of anatomical abnormality detected by ultrasound will be correlated to the level of dural puncture reported on the anaesthesia record.
|Study Design||Observational Model: Cohort
Time Perspective: Retrospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Population||Patients who had a documented, accidental dural puncture during placement of their labor epidural.|
|Condition||Postdural Puncture Headache|
Lumbar ultrasound from L1-S1, carried out using a portable ultrasound system equipped with a 2-5 MHz curved array probe.
Patients who had a documented, accidental dural puncture during placement of their labor epidural.
Intervention: Procedure: Ultrasound
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Actual Study Completion Date||July 2007|
|Primary Completion Date||Not Provided|
|Ages||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Canada|
|Removed Location Countries|
|Other Study ID Numbers||07-05
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Dr. Jose Carvalho, Mount Sinai Hospital|
|Study Sponsor||Samuel Lunenfeld Research Institute, Mount Sinai Hospital|
|PRS Account||Samuel Lunenfeld Research Institute, Mount Sinai Hospital|
|Verification Date||December 2007|