Establishment of a Predictive Model for Post-dural Puncture Headache

NCT ID: NCT06800859

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 480 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2025-12-30

Brief 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). 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

Conditions

Spinal and Epidural Anaesthesia-Induced Headache During Pregnancy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Post-dural Puncture Headache Group in adult

Perform MRI and (or) ultrasound and (or) intraocular pressure measurement before and 24 hours after the puncture

Supplement fluids

Intervention Type: DRUG

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

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

No interventions assigned to this group

Post-dural Puncture Headache Group in children

Perform MRI and (or) ultrasound and (or) intraocular pressure measurement before and 24 hours after the puncture

Supplement fluids

Intervention Type: DRUG

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

Interventions

Supplement fluids

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

Intervention Type: DRUG

Other Intervention Names

Bed rest; Blood patch

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yilin Zhao

OTHER

Sponsor Role: lead

Responsible Party

Yilin Zhao

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yilin Zhao

Role: PRINCIPAL_INVESTIGATOR

Huazhong Universty of Science and Technology

Locations

Tongji Hospital of Tongji Medical College of Huazhong Universtiy of Science and Technology

Wuhan, Hubei, China

Countries

China

Other Identifiers

101787

Identifier Type: -

Identifier Source: org_study_id