Long-term Complications of Unintentional Dural Puncture During Labour Epidurals and Epidural Blood Patch.

Post-Dural Puncture Headache Clinical Trial

Official title:

Long-term Complications of Unintentional Dural Puncture During Labour Epidurals and Epidural Blood Patch.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04696627
• Other study ID #: 20-03
• Status: Completed
• Start date: February 12, 2021
• Est. completion date: May 11, 2021

Study information

• Verified date: February 2021
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: May 11, 2021
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Headache
• Headache
• Headache Disorders
• Post-Dural Puncture Headache
• Wounds and Injuries

Intervention

Other:
• Questionnaire
Participants from all 3 groups will be interviewed

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Chronic headache - questionnaire	The presence of chronic headache defined as pain that lasts or recurs for more than three months.	3 months
Secondary	Presence of Chronic lower back pain - questionnaire	Presence of Chronic lower back pain, with or without neuropathic features, defined as pain that lasts or recurs for more than three months.	3 months
Secondary	Presence of Chronic auditory impairment - questionnaire	The presence of auditory impairment defined as impairment that lasts or recurs for more than three months.	3 months
Secondary	Presence of Chronic visual impairment - questionnaire	The presence of chronic visual impairment defined as impairment that lasts or recurs for more than three months.	3 months
Secondary	Medical interventions for pain/impairment - questionnaire	The treatment of any pain/impairment described by the patient.	3 months
Secondary	Pain disability index - questionnaire	Whether any pain/impairment described by the patient affects activities of daily life.	3 months