Multimodal Approach to the Intrathecal Catheter for Obstetric Accidental Dural Puncture

June 16, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne
Accidental dural puncture is an uncommon complication of epidural analgesia and can cause postdural puncture headache.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Étienne, France
        • CHU Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients without accidental dural puncture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of epidural blood patch
Time Frame: Day: 7
Collect from medical records.
Day: 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
headache intensity
Time Frame: Day: 7
Collect from medical records.
Day: 7
Timeframe for blood patching
Time Frame: Day: 0
Collect from medical records the Timeframe for blood patching
Day: 0
Number of blood patches required
Time Frame: Day: 7
Collect from medical records.
Day: 7
Safety of the technique by number of adverse event
Time Frame: Day: 7
Collect from medical record the adverse event (complications).
Day: 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Pascal MARTIN, MD, CHU Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

June 9, 2023

First Submitted That Met QC Criteria

June 16, 2023

First Posted (Estimated)

June 19, 2023

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRBN632022/CHUSTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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