Multimodal Approach to the Intrathecal Catheter for Obstetric Accidental Dural Puncture

Spinal Anesthetics Causing Adverse Effects in Therapeutic Use Clinical Trial

Official title:

Multimodal Approach to the Intrathecal Catheter for Obstetric Accidental Dural Puncture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05910086
• Other study ID #: IRBN632022/CHUSTE
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Accidental dural puncture is an uncommon complication of epidural analgesia and can cause postdural puncture headache.

Description:

The aim of this study the effectiveness of a protocol implemented in our department, according to the recommendations of good practice, on the reduction of the use of blood patchs in patients who have had an accidental dural puncture during the implementation of their spinal anesthesia, in order to prevent the use of the blood patch. In addition, intensity of headaches is evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients having an accidental dural puncture during the installation of an epidural anesthesia

Exclusion Criteria:

• Patients without accidental dural puncture

Related Conditions & MeSH terms

• Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Intervention

Other:
• collection of data from the medical record
collection of data from the medical record: During epidural space puncture = cerebrospinal fluid (CSF) reflux, presence of glucose / strip, saline injection, intrathecal catheter insertion, intrathecal levobupivacaine and sufentanil injection, catheter insertion time, number of punctures, function of the person performing the procedure. Analgesia and hemodynamics during labor, blood pressure, pulse rate, amount of local anesthetic used, whether emergency cesarean section was performed Demographic data (age, weight, height, body mass index (BMI)) Post-partum monitoring of decubitus or orthostatic headaches, intensity, any other associated clinical signs Analgesics used and their efficacy The use of one or more blood patches, with the volume injected and their efficacy Identification of the breach during epidural analgesia or after delivery Call the patient at 1 week to reassess the episode and its consequences.

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of epidural blood patch	Collect from medical records.	Day: 7
Secondary	headache intensity	Collect from medical records.	Day: 7
Secondary	Timeframe for blood patching	Collect from medical records the Timeframe for blood patching	Day: 0
Secondary	Number of blood patches required	Collect from medical records.	Day: 7
Secondary	Safety of the technique by number of adverse event	Collect from medical record the adverse event (complications).	Day: 7