Spinal Anesthetics Causing Adverse Effects in Therapeutic UseNCT05910086
Multimodal Approach to the Intrathecal Catheter for Obstetric Accidental Dural Puncture
An observational study of Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Accidental dural puncture is an uncommon complication of epidural analgesia and can cause postdural puncture headache. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
- What is being tested?
- collection of data from the medical record
- Type of treatment
- Injection or infusion
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2022to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients having an accidental dural puncture during the installation of an epidural anesthesia will be included.
Who may be able to join
- patients having an accidental dural puncture during the installation of an epidural anesthesia
Who cannot join
- Patients without accidental dural puncture
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- collection of data from the medical record
- Keywords
- Accidental dural puncture, Epidural blood patch, Intrathecal catheter, Postdural puncture headache, Epidural anesthesia, Obstetrics
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of data from the medical recordOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: collection of data from the medical record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of epidural blood patch
Collect from medical records.
Measured: Day: 7
Secondary outcomes (4)
headache intensity
Collect from medical records.
Measured: Day: 7
Timeframe for blood patching
Collect from medical records the Timeframe for blood patching
Measured: Day: 0
Number of blood patches required
Collect from medical records.
Measured: Day: 7
Safety of the technique by number of adverse event
Collect from medical record the adverse event (complications).
Measured: Day: 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Mar 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Anesthetics Causing Adverse Effects in Therapeutic UseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal MARTIN, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910086
- Sponsor's protocol ID
- IRBN632022/CHUSTE
- Status last verified
- Jun 2023
- First submitted
- 9 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Approach to the Intrathecal Catheter for Obstetric Accidental Dural Puncture
- ClinicalTrials.gov ID
- NCT05910086
- Acronym / sponsor ID
- IRBN632022/CHUSTE
- Keywords
- Accidental dural puncture, Epidural blood patch, Intrathecal catheter, Postdural puncture headache, Epidural anesthesia, Obstetrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Accidental dural puncture is an uncommon complication of epidural analgesia and can cause postdural puncture headache.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients having an accidental dural puncture during the installation of an epidural anesthesia | – | Other: collection of data from the medical recordpatients having an accidental dural puncture during the installation of an epidural anesthesia will be included. Analysis datas of medical record. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients having an accidental dural puncture during the installation of an epidural anesthesia will be included.
Key inclusion criteria (1 listed)
- patients having an accidental dural puncture during the installation of an epidural anesthesia
Key exclusion criteria (1 listed)
- Patients without accidental dural puncture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of data from the medical recordcollection 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. | Other | patients having an accidental dural puncture during the installation of an epidural anesthesia |
Primary outcome
Number of epidural blood patch
Time frame: Day: 7
Collect from medical records.
4 secondary outcomes
headache intensity
Time frame: Day: 7
Timeframe for blood patching
Time frame: Day: 0
Number of blood patches required
Time frame: Day: 7
Safety of the technique by number of adverse event
Time frame: Day: 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
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Post-Dural Puncture Headache, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal MARTIN, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of epidural blood patch (time frame: Day: 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.