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OpenTrials
Completed

NCT Number: NCT05910086

Multimodal Approach to the Intrathecal Catheter for Obstetric Accidental Dural Puncture

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

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Key information

Conditions

Spinal Anesthetics Causing Adverse Effects in Therapeutic Use Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases Post-Dural Puncture Headache

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint-Etienne

Saint-Etienne, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients without accidental dural puncture

Treatment and study plan

collection of data from the medical record

Other

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.

Primary outcomes

  1. Number of epidural blood patch

    Time frame: Day: 7

    Collect from medical records.

Secondary outcomes

  1. headache intensity

    Time frame: Day: 7

    Collect from medical records.

  2. Timeframe for blood patching

    Time frame: Day: 0

    Collect from medical records the Timeframe for blood patching

  3. Number of blood patches required

    Time frame: Day: 7

    Collect from medical records.

  4. Safety of the technique by number of adverse event

    Time frame: Day: 7

    Collect from medical record the adverse event (complications).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2023
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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