Clinical trial NCT04696627: Long-term Complications of Unintentional Dural Puncture During Labour Epidurals and Epidural Blood Patch.
Official title: Long-term Complications of Unintentional Dural Puncture During Labour Epidurals and Epidural Blood Patch.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-Dural Puncture Headache
Chronic Headache
Keywords: post-dural puncture headache
labour epidural
chronic headache
chronic backache
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with labour epidurals inserted at Mount Sinai hospital from January 2015 to December 2019 with well-documented recognized unintentional dural punctures will be invited to participate.

Control patients who received labor epidural matched by month of delivery, age, and body mass index (grouped as either below or above a body mass index of 40) will also be approached for enrollment.

Brief summary: The investigators plan to evaluate long-term consequences of unintentional dural puncture in women who had this complication during labor epidural insertion at Mount Sinai Hospital. A dural puncture is the perforation of the dura mater (one of the layers protecting the brain and the spinal cord) by the needle that is used to find and place a catheter in the epidural space. A puncture will cause a leakage of cerebrospinal fluid through the dura that results in an acute and usually self-limited headache in half of patients who have this complication. The usual treatment for this complication is conservative with the use of oral medications like acetaminophen, anti-inflammatory and narcotics. In the severely symptomatic patient, the injection of blood in the epidural space is a more invasive approach performed to "patch" the hole that was created in the dura (epidural blood patch). The objective is to determine whether or not there is a risk of developing long-term effects from the unintentional dural puncture and its treatment by epidural blood patch by comparing women who had a dural puncture during their labour epidural insertion with or without an epidural blood patch with women who received an epidural but did not have a dural puncture during the same period of time.

The hypothesis is that women who had unintentional dural punctures during epidural insertion will develop long-term effects such as chronic headache, chronic backache, chronic auditory or visual disturbances and chronic disability more frequently than women who received an epidural but did not sustain a dural puncture. The investigators also hypothesize that the use of epidural blood patch may change the course of these complications.

Detailed description: The investigators will study women who have sustained an unintentional dural puncture at least one year prior to the start date of the study, and the investigators will study cases occurring during a period of 5 years. These women will be matched by type of procedure (labor epidural), month of delivery and age with women who have received an epidural but did not sustain an unintentional dural puncture. The group of women who sustained dural punctures will be further divided into two groups, whether they have received epidural blood patch or not, to study the influence of the epidural blood patch on the outcomes. Women will have their anesthetic records reviewed to collect data on the anesthetic technique, presence of a dural puncture and treatment if applicable. All patients who qualify will be contacted and invited to take part in this study. Those consenting to the study will be interviewed by phone or answer the survey electronically. During the interview, they will answer questions derived from validated questionnaires for the majority of our outcomes of interest. In the few outcomes where a validated questionnaire does not exist, the investigators will search for our endpoint with dichotomic (yes/no) questions. The investigators will then compare the data gathered in the three different groups to validate or invalidate our hypothesis.

Eligibility criteria: Inclusion Criteria:

* All patients with well-documented recognized unintentional dural punctures during their labor epidural insertion at Mount Sinai Hospital from January 2015 to December 2019 will be approached for enrollment. Control patients who received labor epidural matched by month of delivery and age will also be approached for enrollment.

Exclusion Criteria:

* Patients with preexisting symptoms of chronic headache, or any of the secondary outcomes prior to the unintentional dural puncture will be excluded from this study.

Primary outcomes:
measure: Presence of Chronic headache - questionnaire
timeFrame: 3 months
Secondary outcomes:
measure: Presence of Chronic lower back pain - questionnaire
timeFrame: 3 months
measure: Presence of Chronic auditory impairment - questionnaire
timeFrame: 3 months
measure: Presence of Chronic visual impairment - questionnaire
timeFrame: 3 months
measure: Medical interventions for pain/impairment - questionnaire
timeFrame: 3 months
measure: Pain disability index - questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Jose Carvalho, MD
role: PRINCIPAL_INVESTIGATOR
References: