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Lumbar Spine Ultrasound of Patients With Previous Accidental Dural Puncture During Labour Epidural

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00465166
Recruitment Status : Completed
First Posted : April 24, 2007
Last Update Posted : December 17, 2007
Sponsor:
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Tracking Information
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
Change History
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
 
Descriptive Information
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.
Detailed Description

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen 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
Intervention Procedure: Ultrasound
Lumbar ultrasound from L1-S1, carried out using a portable ultrasound system equipped with a 2-5 MHz curved array probe.
Study Groups/Cohorts 1
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.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 12, 2007)
56
Original Enrollment
 (submitted: April 23, 2007)
20
Actual Study Completion Date July 2007
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Previous dural puncture during labour epidural

Exclusion Criteria:

  • none
Sex/Gender
Sexes Eligible for Study: Female
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  
 
Administrative Information
NCT Number NCT00465166
Other Study ID Numbers 07-05
07-0002-E
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
Collaborators Not Provided
Investigators
Principal Investigator: Jose CA Carvalho, MD PhD MOUNT SINAI HOSPITAL
PRS Account Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Verification Date December 2007