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

NCT ID: NCT00465166

Last Updated: 2007-12-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2007-07-31

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.

Conditions

Postdural Puncture Headache

Keywords

Accidental dural puncture; Labour epidural; Ultrasound; Ligamentum flavum

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

1

Patients who had a documented, accidental dural puncture during placement of their labor epidural.

Ultrasound

Intervention Type: PROCEDURE

Lumbar ultrasound from L1-S1, carried out using a portable ultrasound system equipped with a 2-5 MHz curved array probe.

Interventions

Ultrasound

Lumbar ultrasound from L1-S1, carried out using a portable ultrasound system equipped with a 2-5 MHz curved array probe.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Previous dural puncture during labour epidural

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mount Sinai Hospital

Principal Investigators

Jose CA Carvalho, MD PhD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

07-0002-E

Identifier Type: -

Identifier Source: secondary_id

07-05

Identifier Type: -

Identifier Source: org_study_id