Spinal and Epidural Anaesthesia-Induced Headache During PregnancyNCT06800859
Establishment of a Predictive Model for Post-dural Puncture Headache
An observational study of Spinal and Epidural Anaesthesia-Induced Headache During Pregnancy, run by Yilin Zhao at 1 site in China.
Trial summary
The goal of this clinical trial is to establish a predictive model for post-dural puncture headache. The main questions it aims to answer are: Changes in intracranial pressure after spinal puncture (or lumbar puncture). Read more about this study
- Who is it for?
- Ages 3 to 34 years
- Conditions the study is for
- Spinal and Epidural Anaesthesia-Induced Headache During Pregnancy
- What is being tested?
- Supplement fluids
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2025to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 to 34 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients who need dural puncture
Who may be able to join
- BMI ≤ 30 kg/m² Normal liver and kidney function before surgery Normal coagulation function before surgery Hemoglobin > 70 g/L Platelet count > 80 × 10⁹/L
Who cannot join
- Patients who experience major bleeding during or after surgery Patients with cerebrospinal fluid leakage or other serious malformations Patients with mental health disorders or cognitive dysfunction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital of Tongji Medical College of Huazhong Universtiy of Science and Technology
Wuhan, Hubei, 430030
About this study
The goal of this clinical trial is to establish a predictive model for post-dural puncture headache. The main questions it aims to answer are:
Changes in intracranial pressure after spinal puncture (or lumbar puncture). When post-dural puncture headache occurs, the optic nerve sheath diameter (ONSD) change When the optic nerve sheath diameter (ONSD) and (or) Intraocular Pressure (IOP) reaches a certain threshold, does proactive treatment reduce the incidence of postoperative headaches? Researchers will measure the optic nerve sheath diameter (ONSD) using ultrasound and ( or ) magnetic resonance imaging (MRI) before and after spinal puncture.
Read more
Researchers will measure the Intraocular Pressure (IOP) using ICARE before and after spinal puncture.
Participants will:
Undergo ultrasound and (or) magnetic resonance imaging (MRI) examinations before and after spinal puncture Undergo ICARE examinations before and after spinal puncture
Read the detailed description
Post-dural Puncture Headache (PDPH) refers to a specific type of headache that occurs after patients receive intrathecal anesthesia or a lumbar puncture, resulting from the leakage of cerebrospinal fluid (CSF) due to the puncture of the dura mater and arachnoid mater. This type of headache typically occurs within 24 to 48 hours after the puncture and is characterized primarily by positional headaches, meaning that the headache worsens when the patient is standing or sitting and improves when lying down. The headache is often accompanied by symptoms such as neck stiffness, nausea, vomiting, tinnitus, and blurred vision.
The primary mechanism of PDPH is the leakage of cerebrospinal fluid from the puncture site after the dura and arachnoid are punctured, leading to a decrease in CSF pressure. The reduction in cerebrospinal fluid can cause several physiological changes:Decreased CSF Pressure: The reduction of CSF leads to a drop in intracranial pressure, which alters the mechanisms that support the brain, resulting in pain.Meningeal Tension: The decrease in CSF may cause tension on the meninges and nerve roots, leading to pain sensations.Vasodilation: The drop in intracranial pressure can trigger a reflexive dilation of cerebral blood vessels, further exacerbating the pain.The incidence of PDPH is associated with various factors, including the patient's age, sex, body type, type of surgery performed, and the type and size of the puncture needle used. Smaller needles (such as 25G or thinner) and non-cutting needles (such as Sprotte needles) can significantly reduce the incidence of PDPH, whereas larger and cutting needles (such as Quincke needles) are associated with a higher incidence. Younger patients and females are more prone to developing PDPH. Additionally, multiple punctures increase the risk of PDPH.
Timely and effective treatment can significantly reduce the occurrence of PDPH; however, there is currently a lack of monitoring methods for PDPH. This study aims to establish a predictive model for the occurrence of PDPH by measuring postural cerebrospinal fluid pressure using ultrasound, which can enable early prediction and treatment of PDPH, thereby significantly improving patient comfort and recovery processes.
The goal of this clinical trial is to establish a predictive model for post-dural puncture headache,with the goal of implementing proactive interventions and treatments to reduce the incidence of PDPH and improve clinical management. Therefore, establishing an effective early warning model is crucial Participants will receive ultrasound, magnetic resonance imaging (MRI) and (or ) ICARE examinations before and after spinal puncture
- Being tested
- Supplement fluids
- Keywords
- Spinal anestheisa, Pural-Puncture, Headache, Complications
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplement fluidsDrug
Also called Bed rest, Blood patch
To ensure optimal recovery and manage potential complications, patients are advised to supplement fluids by increasing their oral intake or receiving intravenous fluids as necessary. Bed rest is recommended to reduce physical strain and promote healing. Additionally, a blood patch procedure may be performed to alleviate symptoms such as headaches that can occur after certain medical procedures, particularly spinal taps. This involves injecting a small amount of the patient's own blood into the epidural space to seal any leaks of cerebrospinal fluid, thereby providing relief and aiding in recovery. Proper monitoring and follow-up care are essential to ensure the effectiveness of these interventions
| Study group | Role | What they receive |
|---|---|---|
| No Post-dural Puncture Headache Group in adult | Perform MRI and (or) ultrasound and (or) intraocular pressure measurement before and 24 hours after the puncture | |
| Post-dural Puncture Headache Group in adult | Perform MRI and (or) ultrasound and (or) intraocular pressure measurement before and 24 hours after the puncture Receives: Drug: Supplement fluids | |
| No Post-dural Puncture Headache Group in children | Perform MRI and (or) ultrasound and (or) intraocular pressure measurement before and 24 hours after the puncture | |
| Post-dural Puncture Headache Group in children | Perform MRI and (or) ultrasound and (or) intraocular pressure measurement before and 24 hours after the puncture Receives: Drug: Supplement fluids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter (ONSD) measurement by MRI
ONSD Measurement by MRI
Measured: 1 hour before dural puncture
Optic nerve sheath diameter (ONSD) measurement by MRI
ONSD Measurement by MRI
Measured: 24 hours after dural puncture
Optic nerve sheath diameter (ONSD) measurement by B ultrasound
ONSD Measurement by B ultrasound
Measured: 1 hour before dural puncture
Optic nerve sheath diameter (ONSD) measurement by B ultrasound
ONSD Measurement by B ultrasound
Measured: 8 hours after dural puncture
Optic nerve sheath diameter (ONSD) measurement by B ultrasound
ONSD Measurement by B ultrasound
Measured: 24 hours after dural puncture
Optic nerve sheath diameter (ONSD) measurement by B ultrasound
ONSD Measurement by B ultrasound
Measured: 48 hours after dural Puncture
Intraocular Pressure messurement
Intraocular Pressure measurement by Icare
Measured: 1 Hour before dural Puncture
Intraocular Pressure messurement
Intraocular Pressure measurement by Icare
Measured: 8 hours after dural puncture
Intraocular Pressure messurement
Intraocular Pressure measurement by Icare
Measured: 24 hours after dural puncture
Intraocular Pressure messurement
Intraocular Pressure measurement by Icare
Measured: 48 hours after dural puncture
Secondary outcomes (3)
number of punctures
number of punctures
Measured: 24 hours after dural puncture
type of puncture needle
type of puncture needle
Measured: 24 hours after dural puncture
Onset time of postoperative headache and duration
Onset time of postoperative headache" and "duration
Measured: 24 hours after dural puncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start20 Jan 2025 (estimated)
- Primary completion20 May 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal and Epidural Anaesthesia-Induced Headache During PregnancyStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yilin Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yilin Zhao, Tongji Hospital
- Investigators
- Yilin Zhao, Principal investigator, Huazhong Universty of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800859
- Sponsor's protocol ID
- 101787
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Predictive Model for Post-dural Puncture Headache
- ClinicalTrials.gov ID
- NCT06800859
- Acronym / sponsor ID
- 101787
- Keywords
- Spinal anestheisa, Pural-Puncture, Headache, Complications
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Yilin ZhaoUniversity, hospital or other
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 20 May 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 30 Jan 2025 (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.
The goal of this clinical trial is to establish a predictive model for post-dural puncture headache. The main questions it aims to answer are:
Changes in intracranial pressure after spinal puncture (or lumbar puncture). When post-dural puncture headache occurs, the optic nerve sheath diameter (ONSD) change When the optic nerve sheath diameter (ONSD) and (or) Intraocular Pressure (IOP) reaches a certain threshold, does proactive treatment reduce the incidence of postoperative headaches? Researchers will measure the optic nerve sheath diameter (ONSD) using ultrasound and ( or ) magnetic resonance imaging (MRI) before and after spinal puncture.
Researchers will measure the Intraocular Pressure (IOP) using ICARE before and after spinal puncture.
Participants will:
Undergo ultrasound and (or) magnetic resonance imaging (MRI) examinations before and after spinal puncture Undergo ICARE examinations before and after spinal puncture
Detailed description
Post-dural Puncture Headache (PDPH) refers to a specific type of headache that occurs after patients receive intrathecal anesthesia or a lumbar puncture, resulting from the leakage of cerebrospinal fluid (CSF) due to the puncture of the dura mater and arachnoid mater. This type of headache typically occurs within 24 to 48 hours after the puncture and is characterized primarily by positional headaches, meaning that the headache worsens when the patient is standing or sitting and improves when lying down. The headache is often accompanied by symptoms such as neck stiffness, nausea, vomiting, tinnitus, and blurred vision.
The primary mechanism of PDPH is the leakage of cerebrospinal fluid from the puncture site after the dura and arachnoid are punctured, leading to a decrease in CSF pressure. The reduction in cerebrospinal fluid can cause several physiological changes:Decreased CSF Pressure: The reduction of CSF leads to a drop in intracranial pressure, which alters the mechanisms that support the brain, resulting in pain.Meningeal Tension: The decrease in CSF may cause tension on the meninges and nerve roots, leading to pain sensations.Vasodilation: The drop in intracranial pressure can trigger a reflexive dilation of cerebral blood vessels, further exacerbating the pain.The incidence of PDPH is associated with various factors, including the patient's age, sex, body type, type of surgery performed, and the type and size of the puncture needle used. Smaller needles (such as 25G or thinner) and non-cutting needles (such as Sprotte needles) can significantly reduce the incidence of PDPH, whereas larger and cutting needles (such as Quincke needles) are associated with a higher incidence. Younger patients and females are more prone to developing PDPH. Additionally, multiple punctures increase the risk of PDPH.
Timely and effective treatment can significantly reduce the occurrence of PDPH; however, there is currently a lack of monitoring methods for PDPH. This study aims to establish a predictive model for the occurrence of PDPH by measuring postural cerebrospinal fluid pressure using ultrasound, which can enable early prediction and treatment of PDPH, thereby significantly improving patient comfort and recovery processes.
The goal of this clinical trial is to establish a predictive model for post-dural puncture headache,with the goal of implementing proactive interventions and treatments to reduce the incidence of PDPH and improve clinical management. Therefore, establishing an effective early warning model is crucial Participants will receive ultrasound, magnetic resonance imaging (MRI) and (or ) ICARE examinations before and after spinal puncture
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No Post-dural Puncture Headache Group in adult | – | –Perform MRI and (or) ultrasound and (or) intraocular pressure measurement before and 24 hours after the puncture |
| Post-dural Puncture Headache Group in adult | – | Drug: Supplement fluidsPerform MRI and (or) ultrasound and (or) intraocular pressure measurement before and 24 hours after the puncture |
| No Post-dural Puncture Headache Group in children | – | –Perform MRI and (or) ultrasound and (or) intraocular pressure measurement before and 24 hours after the puncture |
| Post-dural Puncture Headache Group in children | – | Drug: Supplement fluidsPerform MRI and (or) ultrasound and (or) intraocular pressure measurement before and 24 hours after the puncture |
Who may qualify
- Ages
- 3 to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients who need dural puncture
Key inclusion criteria (1 listed)
- BMI ≤ 30 kg/m² Normal liver and kidney function before surgery Normal coagulation function before surgery Hemoglobin > 70 g/L Platelet count > 80 × 10⁹/L
Key exclusion criteria (1 listed)
- Patients who experience major bleeding during or after surgery Patients with cerebrospinal fluid leakage or other serious malformations Patients with mental health disorders or cognitive dysfunction
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 |
|---|---|---|
| Supplement fluidsAlso: Bed rest, Blood patchTo ensure optimal recovery and manage potential complications, patients are advised to supplement fluids by increasing their oral intake or receiving intravenous fluids as necessary. Bed rest is recommended to reduce physical strain and promote healing. Additionally, a blood patch procedure may be performed to alleviate symptoms such as headaches that can occur after certain medical procedures, particularly spinal taps. This involves injecting a small amount of the patient's own blood into the epidural space to seal any leaks of cerebrospinal fluid, thereby providing relief and aiding in recovery. Proper monitoring and follow-up care are essential to ensure the effectiveness of these interventions | Drug | Post-dural Puncture Headache Group in adult, Post-dural Puncture Headache Group in children |
Primary outcome
Optic nerve sheath diameter (ONSD) measurement by MRI
Time frame: 1 hour before dural puncture
ONSD Measurement by MRI
Optic nerve sheath diameter (ONSD) measurement by MRI
Time frame: 24 hours after dural puncture
ONSD Measurement by MRI
Optic nerve sheath diameter (ONSD) measurement by B ultrasound
Time frame: 1 hour before dural puncture
ONSD Measurement by B ultrasound
Optic nerve sheath diameter (ONSD) measurement by B ultrasound
Time frame: 8 hours after dural puncture
ONSD Measurement by B ultrasound
Optic nerve sheath diameter (ONSD) measurement by B ultrasound
Time frame: 24 hours after dural puncture
ONSD Measurement by B ultrasound
Optic nerve sheath diameter (ONSD) measurement by B ultrasound
Time frame: 48 hours after dural Puncture
ONSD Measurement by B ultrasound
Intraocular Pressure messurement
Time frame: 1 Hour before dural Puncture
Intraocular Pressure measurement by Icare
Intraocular Pressure messurement
Time frame: 8 hours after dural puncture
Intraocular Pressure measurement by Icare
Intraocular Pressure messurement
Time frame: 24 hours after dural puncture
Intraocular Pressure measurement by Icare
Intraocular Pressure messurement
Time frame: 48 hours after dural puncture
Intraocular Pressure measurement by Icare
3 secondary outcomes
number of punctures
Time frame: 24 hours after dural puncture
type of puncture needle
Time frame: 24 hours after dural puncture
Onset time of postoperative headache and duration
Time frame: 24 hours after dural puncture
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
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.
Yilin Zhao principal investigator
Huazhong Universty of Science and Technology
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 and Epidural Anaesthesia-Induced Headache During Pregnancy, run by Yilin Zhao at 1 site in China.
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: enrolling by invitation, as of the sponsor's last update on 30 Jan 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Optic nerve sheath diameter (ONSD) measurement by MRI (time frame: 1 hour before dural puncture). The study lists 10 primary outcomes in all. 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 30 Jan 2025; AzTrials last refreshed its copy on 26 Oct 2026.