Establishment of a Predictive Model for Post-dural Puncture Headache

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Spinal and Epidural Anaesthesia-Induced Headache During Pregnancy
• Intervention / Treatment: Drug: Supplement fluids

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 Type: Observational
• Enrollment (Estimated): 480

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital of Tongji Medical College of Huazhong Universtiy of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients who need dural puncture

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: 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; Other Names: Blood patch; Bed rest
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	Drug: 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; Other Names: Blood patch; Bed rest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optic nerve sheath diameter (ONSD) measurement by MRI	ONSD Measurement by MRI	1 hour before dural puncture
Optic nerve sheath diameter (ONSD) measurement by MRI	ONSD Measurement by MRI	24 hours after dural puncture
Optic nerve sheath diameter (ONSD) measurement by B ultrasound	ONSD Measurement by B ultrasound	1 hour before dural puncture
Optic nerve sheath diameter (ONSD) measurement by B ultrasound	ONSD Measurement by B ultrasound	8 hours after dural puncture
Optic nerve sheath diameter (ONSD) measurement by B ultrasound	ONSD Measurement by B ultrasound	24 hours after dural puncture
Optic nerve sheath diameter (ONSD) measurement by B ultrasound	ONSD Measurement by B ultrasound	48 hours after dural Puncture
Intraocular Pressure messurement	Intraocular Pressure measurement by Icare	1 Hour before dural Puncture
Intraocular Pressure messurement	Intraocular Pressure measurement by Icare	8 hours after dural puncture
Intraocular Pressure messurement	Intraocular Pressure measurement by Icare	24 hours after dural puncture
Intraocular Pressure messurement	Intraocular Pressure measurement by Icare	48 hours after dural puncture

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of punctures	number of punctures	24 hours after dural puncture
type of puncture needle	type of puncture needle	24 hours after dural puncture
Onset time of postoperative headache and duration	Onset time of postoperative headache" and "duration	24 hours after dural puncture

Collaborators and Investigators

• Sponsor: YiLin Zhao
• Investigators: Principal Investigator: Yilin Zhao, Huazhong Universty of Science and Technology

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2025
• Primary Completion (Estimated): May 20, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Headache; Complications; Spinal anestheisa; Pural-Puncture
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Dural Puncture Headache
• Other Study ID Numbers: 101787

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No