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CompletedNCT05910086Updated Jun 18, 2023

Multimodal Approach to the Intrathecal Catheter for Obstetric Accidental Dural Puncture

An observational study in Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-18.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
39
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Keywords

  • Accidental dural puncture
  • Epidural blood patch
  • Intrathecal catheter
  • Postdural puncture headache
  • Epidural anesthesia
  • Obstetrics
03

In context

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients having an accidental dural puncture during the installation of an epidural anesthesia will be included.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients without accidental dural puncture
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
39 participants (actual)
Patient registry
No

Groups and cohorts

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

    patients having an accidental dural puncture during the installation of an epidural anesthesia will be included. Analysis datas of medical record.

    Other: collection of data from the medical record

Interventions

  • Othercollection of data from the medical record

    collection of data from the medical record: 1. 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. 2. Analgesia and hemodynamics during labor, blood pressure, pulse rate, amount of local anesthetic used, whether emergency cesarean section was performed 3. Demographic data (age, weight, height, body mass index (BMI)) 4. Post-partum monitoring of decubitus or orthostatic headaches, intensity, any other associated clinical signs 5. Analgesics used and their efficacy 6. The use of one or more blood patches, with the volume injected and their efficacy 7. Identification of the breach during epidural analgesia or after delivery 8. Call the patient at 1 week to reassess the episode and its consequences.

06

What researchers measure

Primary outcomes

  1. Number of epidural blood patch

    Collect from medical records.

    Time frame: Day: 7

Secondary outcomes

  1. headache intensity

    Collect from medical records.

    Time frame: Day: 7

  2. Timeframe for blood patching

    Collect from medical records the Timeframe for blood patching

    Time frame: Day: 0

  3. Number of blood patches required

    Collect from medical records.

    Time frame: Day: 7

  4. Safety of the technique by number of adverse event

    Collect from medical record the adverse event (complications).

    Time frame: Day: 7

07

Study locations

1 site
  • CHU Saint-Etienne
    Saint-Étienne, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05910086
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Responsible party
Sponsor
First posted
Jun 18, 2023
Start date
Mar 1, 2022
Primary completion
Feb 1, 2023
Completion
Feb 1, 2023
Last update
Jun 18, 2023

Study contacts

Pascal MARTIN, MD
principal investigator · CHU Saint-Etienne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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