Multimodal Approach to the Intrathecal Catheter for Obstetric Accidental Dural Puncture

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Completed

CT.gov ID

NCT05910086

Collaborator

(none)

Enrollment

Location

11.1

Actual Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Spinal Anesthetics Causing Adverse Effects in Therapeutic Use	Other: collection of data from the medical record

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 Design

Study Type:

Observational

Actual Enrollment :

39 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Multimodal Approach to the Intrathecal Catheter for Obstetric Accidental Dural Puncture

Actual Study Start Date :

Mar 1, 2022

Actual Primary Completion Date :

Feb 1, 2023

Actual Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	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: 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.

Arm

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: 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.

Outcome Measures

Primary Outcome Measures

Number of epidural blood patch [Day: 7]
Collect from medical records.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Patients without accidental dural puncture

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Saint-Etienne	Saint-Étienne		France

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Saint Etienne

ClinicalTrials.gov Identifier:

NCT05910086

Other Study ID Numbers:

IRBN632022/CHUSTE

First Posted:

Jun 18, 2023

Last Update Posted:

Jun 18, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne

Accidental dural puncture

Epidural blood patch

Intrathecal catheter

Postdural puncture headache

Epidural anesthesia

Obstetrics

Study Results

No Results Posted as of Jun 18, 2023