Multimodal Approach to the Intrathecal Catheter for Obstetric Accidental Dural Puncture

NCT05910086 | Completed

• 1 other identifier: IRBN632022/CHUSTE
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of epidural blood patch

  Collect from medical records.

  Day: 7

Secondary Outcomes (4)

• headache intensity

  Day: 7

• Timeframe for blood patching

  Day: 0

• Number of blood patches required

  Day: 7

• Safety of the technique by number of adverse event

  Day: 7

Study Arms (1)

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

collection of data from the medical record OTHER

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients without accidental dural puncture

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Pascal MARTIN, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 18, 2023
• Study Start: March 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)